Study of SD-101 in Combination With Localized Low-dose Radiation in Patients With Untreated Low-grade B-cell Lymphoma
Study Details
Study Description
Brief Summary
To assess the safety and tolerability of escalating doses of SD-101 in combination with localized low-dose radiation therapy in adult subjects with untreated low-grade B-cell lymphoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SD-101 in combination with low-dose radiation PART 1 Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1 COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2 Cycle 1: Required Radiation: 2 fractions of 2 Gy over 2 days at Days -1 and 1 COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 Cycle 2: Optional Radiation: 2 fractions of 2 Gy over 2 days at Days 180 and 181 COHORT 1: 1 mg/mL at Days 181, 188, 195, 202, and 209 COHORT 2: 8 mg/mL at Days 181, 188, 195, 202, and 209 |
Drug: SD-101
Radiation: Radiation therapy
|
Outcome Measures
Primary Outcome Measures
- Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD). [Up to Day 36]
- Number of Participants Experiencing Injection-site Reactions (ISRs) [Up to Day 36]
Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain
- Number of Participants Experiencing Serious Adverse Events (SAEs) [Up to 38 weeks]
- Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB) [Change from Day 8 to Day 9]
Fold change of IFN-responsive gene expression relative to Day 8
Secondary Outcome Measures
- Number of Participants With Preliminary Response - Local (Injected Lesions) [Up to 38 weeks]
Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
- Number of Participants With Preliminary Response - Systemic (Non-injected Lesions) [Up to 38 weeks]
Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Biopsy confirmed, untreated, low-grade B-cell lymphoma, including follicular (Grade 1, 2, or 3A) [Harris, Swerdlow et al. 2008] or marginal, or CLL/SLL with lymph node involvement.
-
At least 2 sites of measurable disease per Cheson criteria (must measure at least 1.5 cm in any diameter or 1.0 cm in the shortest diameter if one of the diameters is not ≥ 1.5 cm), one of which must be palpable and easily accessible in a low-risk site (eg, inguinal, axillary, cervical, subcutaneous) for intratumoral injection (denoted as "Lesion A" in Treatment Cycle 1) and at least one additional untreated lesion that is located outside the radiation field of the treated lesion (Lesion A) and is accessible for an FNA aspirate.
-
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0 or 1
-
Aged 18 years and older
-
Absolute neutrophil count (ANC) ≥ 1500/mm3
-
Platelet count > 100,000/µL
-
Serum creatinine (Cr) ≤ 1.5 x upper limit of normal (ULN).
-
Serum total bilirubin ≤ 1.5 x the ULN.
-
Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
-
International normalized ratio or prothrombin time (PT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy and the PT or partial thromboplastin time (PTT) must be within the therapeutic range of the intended use of anticoagulants.
-
Activated PTT (aPTT) ≤ 1.5 x ULN unless subject is receiving anticoagulant therapy, and the PT or PTT is within therapeutic range of intended use of anticoagulants.
-
Female subjects must have a negative urine or serum pregnancy test within 72 hours prior to taking study medication if of childbearing potential as defined in this protocol. Women of childbearing potential (WOCBP) must be willing to use 2 medically acceptable method of contraceptive from Day 1 through 120 days after the last dose of trial treatment. The 2 medically acceptable birth control methods can be either 2 barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom (by the partner), cooper intrauterine device, sponge, or spermicide as per local regulations or guidelines. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
-
Ability to understand and sign informed consent form (ICF) and comply with treatment protocol
Exclusion Criteria:
-
Diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy (including immune modulators or systemic corticosteroids) within 7 days prior to study enrollment.
-
Positive for hepatitis B (HBsAg reactive), HCV ribonucleic acid (RNA) qualitative, or human immunodeficiency virus (HIV)( HIV 1/2 antibodies)
-
Diagnosis of mantle or diffuse large-cell lymphoma, Grade 3B follicular lymphoma [Harris, Swerdlow et al. 2008] or gastric mucosa-associated lymphoid tissue (MALT) lymphoma
-
Clinically significant pleural effusion
-
Active infection including cytomegalovirus
-
Pregnant or breast feeding within the projected duration of trial participation through 4 months after the last dose of study treatment.
-
Autoimmune disease including systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjӧgren's syndrome, autoimmune thrombocytopenia, history of uveitis, or other if clinically significant
-
Lymphoma involvement of the central nervous system
-
Received any prior therapy for lymphoma
-
Use of any investigational agent within the last 28 days
-
Serious, non-healing wound, ulcer, or bone fracture.
-
If a subject received major surgery, must have recovered adequately from the toxicity and/or complications from the intervention prior to enrollment.
-
Clinically significant cardiovascular disease (eg, uncontrolled hypertension, myocardial infarction, unstable angina), New York Heart Association (NYHA) Grade II or greater congestive heart failure, serious cardiac arrhythmia requiring medication within 1 year prior to Day -1 (Visit 1); Grade II or greater peripheral vascular disease at study entry
-
Any other significant medical or psychiatric condition, laboratory abnormality, or difficulty complying with protocol requirements that may increase the risk associated with study participation or study drug administration that may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for this study
-
History of sensitivity to any component of SD-101
-
A diagnosis of cancer within the last 3 years prior to enrollment or any known additional malignancy that is progressing or requires active treatment. Exceptions are B-cell lymphoma, basal cell carcinoma of the skin, squamous cell carcinoma of the skin that has undergone potentially curative therapy, and in situ cervical cancer.
-
Is taking systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Stanford University School of Medicine | Stanford | California | United States | 94305-5151 |
| 2 | Northwestern University | Chicago | Illinois | United States | 60611 |
| 3 | University of Iowa Hospitals and Clinics | Iowa City | Iowa | United States | 52242 |
| 4 | Washington University School of Medicine | Saint Louis | Missouri | United States | 63110 |
| 5 | University of Rochester Medical Center | Rochester | New York | United States | 14642 |
Sponsors and Collaborators
- Dynavax Technologies Corporation
Investigators
- Study Director: Abraham Leung, MD, Dynavax Technologies Corporation
Study Documents (Full-Text)
More Information
Publications
None provided.- DV3-LYM-01
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Period Title: PART 1: Dose Escalation | ||||
| STARTED | 3 | 3 | 3 | 4 |
| COMPLETED | 2 | 0 | 0 | 0 |
| NOT COMPLETED | 1 | 3 | 3 | 4 |
| Period Title: PART 1: Dose Escalation | ||||
| STARTED | 7 | 0 | 0 | 9 |
| COMPLETED | 0 | 0 | 0 | 0 |
| NOT COMPLETED | 7 | 0 | 0 | 9 |
Baseline Characteristics
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL | Total |
|---|---|---|---|---|---|
| Arm/Group Description | PART 1 COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 | Total of all reporting groups |
| Overall Participants | 10 | 3 | 3 | 13 | 29 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
7
70%
|
2
66.7%
|
2
66.7%
|
7
53.8%
|
18
62.1%
|
| >=65 years |
3
30%
|
1
33.3%
|
1
33.3%
|
6
46.2%
|
11
37.9%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
56.9
(13.53)
|
56
(9.54)
|
61
(16.52)
|
62.7
(12.32)
|
59.8
(12.59)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
4
40%
|
2
66.7%
|
1
33.3%
|
6
46.2%
|
13
44.8%
|
| Male |
6
60%
|
1
33.3%
|
2
66.7%
|
7
53.8%
|
16
55.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |||||
| Hispanic or Latino |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Not Hispanic or Latino |
10
100%
|
3
100%
|
3
100%
|
13
100%
|
29
100%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
1
10%
|
0
0%
|
0
0%
|
0
0%
|
1
3.4%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| White |
8
80%
|
3
100%
|
3
100%
|
12
92.3%
|
26
89.7%
|
| More than one race |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Unknown or Not Reported |
1
10%
|
0
0%
|
0
0%
|
1
7.7%
|
2
6.9%
|
| Region of Enrollment (Count of Participants) | |||||
| United States |
10
100%
|
3
100%
|
3
100%
|
13
100%
|
29
100%
|
Outcome Measures
| Title | Number of Participants Experiencing Dose-limiting Toxicities (DLTs) and Maximum Tolerated Dose (MTD). |
|---|---|
| Description | |
| Time Frame | Up to Day 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 10 | 3 | 3 | 13 |
| Number [participants] |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | 1 mg/mL, 2 mg/mL, 4 mg/mL, 8 mg/mL |
|---|---|---|
| Comments | MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted. | |
| Type of Statistical Test | Other | |
| Comments | MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted. | |
| Statistical Test of Hypothesis | p-Value | |
| Comments | ||
| Method | ||
| Comments | ||
| Other Statistical Analysis | MTD was not observed because no DLTs occurred at the maximum dose tested. Because this is a safety endpoint, a statistical analysis was not conducted. | |
| Title | Number of Participants Experiencing Injection-site Reactions (ISRs) |
|---|---|
| Description | Injection site reaction 1 = Redness, Injection site reaction 2 = Swelling, Injection site reaction 3 = Pain |
| Time Frame | Up to Day 36 |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 10 | 3 | 3 | 13 |
| Injection site reaction 1 |
4
40%
|
0
0%
|
1
33.3%
|
5
38.5%
|
| Injection site reaction 2 |
4
40%
|
1
33.3%
|
2
66.7%
|
2
15.4%
|
| Injection site reaction 3 |
7
70%
|
3
100%
|
1
33.3%
|
6
46.2%
|
| Title | Number of Participants Experiencing Serious Adverse Events (SAEs) |
|---|---|
| Description | |
| Time Frame | Up to 38 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| Safety population |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 10 | 3 | 3 | 13 |
| Renal and urinary disorders |
0
0%
|
0
0%
|
0
0%
|
1
7.7%
|
| Respiratory, thoracic and mediastinal disorders |
0
0%
|
0
0%
|
1
33.3%
|
0
0%
|
| Total # of participants with SAEs |
0
0%
|
0
0%
|
1
33.3%
|
1
7.7%
|
| Title | Pharmacodynamic Profile - Expression of IFN-responsive Genes (GBP-1, ISG-54, MCP-1, and MxB) |
|---|---|
| Description | Fold change of IFN-responsive gene expression relative to Day 8 |
| Time Frame | Change from Day 8 to Day 9 |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29 PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 10 | 3 | 3 | 13 |
| Geometric Mean (Standard Deviation) [Fold Change] |
7.42
(4.78)
|
8.06
(2.05)
|
9.89
(.59)
|
7.78
(7.54)
|
| Title | Number of Participants With Preliminary Response - Local (Injected Lesions) |
|---|---|
| Description | Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions. |
| Time Frame | Up to 38 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 9 | 3 | 3 | 13 |
| Count of Participants [Participants] |
6
60%
|
3
100%
|
1
33.3%
|
8
61.5%
|
| Title | Number of Participants With Preliminary Response - Systemic (Non-injected Lesions) |
|---|---|
| Description | Subjects with maximum decrease of 50% or greater in sum of products of diameters of lesions. |
| Time Frame | Up to 38 weeks |
Outcome Measure Data
| Analysis Population Description |
|---|
| ITT population |
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL |
|---|---|---|---|---|
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 |
| Measure Participants | 9 | 3 | 3 | 13 |
| Count of Participants [Participants] |
2
20%
|
0
0%
|
0
0%
|
2
15.4%
|
Adverse Events
| Time Frame | Up to 38 weeks | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | ||||||||
| Arm/Group Title | 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL | ||||
| Arm/Group Description | PART 1: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 1: 1 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 2: 2 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1 COHORT 3: 4 mg/mL at Days 1, 8, 15, 22, and 29 | PART 1: COHORT 4: 8 mg/mL at Days 1, 8, 15, 22, and 29; PART 2: COHORT 2: 8 mg/mL at Days 1, 8, 15, 22, and 29 | ||||
All Cause Mortality |
||||||||
| 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
Serious Adverse Events |
||||||||
| 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/13 (7.7%) | ||||
| Renal and urinary disorders | ||||||||
| Focal segmental glomerulosclerosis | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Pulmonary embolism | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| 1 mg/mL | 2 mg/mL | 4 mg/mL | 8 mg/mL | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 10/10 (100%) | 3/3 (100%) | 3/3 (100%) | 13/13 (100%) | ||||
| Blood and lymphatic system disorders | ||||||||
| Anaemia | 1/10 (10%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Lymphadenopathy | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Neutropenia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 3/13 (23.1%) | ||||
| Thrombocytopenia | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Cardiac disorders | ||||||||
| Atrioventricular block first degree | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Tachycardia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Eye disorders | ||||||||
| Dry eye | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Eye irritation | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Gastrointestinal disorders | ||||||||
| Abdominal Discomfort | 1/10 (10%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Abdominal pain | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Abdominal pain lower | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Abdominal pain upper | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Constipation | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Diarrhoea | 3/10 (30%) | 0/3 (0%) | 1/3 (33.3%) | 4/13 (30.8%) | ||||
| Nausea | 2/10 (20%) | 1/3 (33.3%) | 0/3 (0%) | 8/13 (61.5%) | ||||
| Pancreatic cyst | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Paraesthesia oral | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Stomatitis | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Swollen tongue | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Vomiting | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 5/13 (38.5%) | ||||
| General disorders | ||||||||
| Asthenia | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Chest discomfort | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Chills | 8/10 (80%) | 2/3 (66.7%) | 3/3 (100%) | 13/13 (100%) | ||||
| Exercise tolerance decreased | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Fatigue | 8/10 (80%) | 3/3 (100%) | 3/3 (100%) | 12/13 (92.3%) | ||||
| Feeling hot | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Gait disturbance | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Influenza like illness | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Injection Site Erythema | 4/10 (40%) | 0/3 (0%) | 1/3 (33.3%) | 3/13 (23.1%) | ||||
| Injection Site Swelling | 3/10 (30%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Injection site discolouration | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Injection site pain | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Injection site pruritus | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Injection site rash | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Local swelling | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Malaise | 9/10 (90%) | 2/3 (66.7%) | 3/3 (100%) | 13/13 (100%) | ||||
| Oedema | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Oedema peripheral | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Peripheral swelling | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Pyrexia | 4/10 (40%) | 1/3 (33.3%) | 2/3 (66.7%) | 12/13 (92.3%) | ||||
| Hepatobiliary disorders | ||||||||
| Hyperbilirubinaemia | 0/10 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Immune system disorders | ||||||||
| Food allergy | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Infections and infestations | ||||||||
| Bronchitis | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Herpes virus infection | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Nasopharyngitis | 1/10 (10%) | 2/3 (66.7%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Pneumonia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Upper respiratory tract infection | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Urinary tract infection | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 1/13 (7.7%) | ||||
| Viral infection | 1/10 (10%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Injury, poisoning and procedural complications | ||||||||
| Excoriation | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Post procedural haematoma | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Post-traumatic neck syndrome | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Investigations | ||||||||
| Aspartate aminotransferase increased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Blood bilirubin increased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Blood calcium decreased | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Blood chloride increased | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Dna antibody positive | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Eosinophil count decreased | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Gamma-glutamyltransferase increased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Lymphocyte count decreased | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Lymphocyte count increased | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Neutrophil count decreased | 2/10 (20%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Neutrophil count increased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Platelet count decreased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Protein total decreased | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| White blood cell count decreased | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Metabolism and nutrition disorders | ||||||||
| Decreased appetite | 2/10 (20%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Hyperglycaemia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Hyperuricaemia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Hypoalbuminaemia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Musculoskeletal and connective tissue disorders | ||||||||
| Arthralgia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Back pain | 0/10 (0%) | 1/3 (33.3%) | 1/3 (33.3%) | 1/13 (7.7%) | ||||
| Medial tibial stress syndrome | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Muscle spasms | 2/10 (20%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Musculoskeletal chest pain | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Musculoskeletal stiffness | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Myalgia | 7/10 (70%) | 3/3 (100%) | 3/3 (100%) | 13/13 (100%) | ||||
| Neck pain | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Pain in extremity | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Neoplasms benign, malignant and unspecified (incl cysts and polyps) | ||||||||
| Haemangioma | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Nervous system disorders | ||||||||
| Dizziness | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Dysgeusia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Headache | 8/10 (80%) | 3/3 (100%) | 3/3 (100%) | 11/13 (84.6%) | ||||
| Hypoaesthesia | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Parosmia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Presyncope | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Psychiatric disorders | ||||||||
| Anxiety | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Confusional state | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Disorientation | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Insomnia | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Renal and urinary disorders | ||||||||
| Hypertonic bladder | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Pollakiuria | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Proteinuria | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Urinary incontinence | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Reproductive system and breast disorders | ||||||||
| Menstruation irregular | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Respiratory, thoracic and mediastinal disorders | ||||||||
| Chronic obstructive pulmonary disease | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Cough | 1/10 (10%) | 1/3 (33.3%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Dyspnoea | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Increased viscosity of bronchial secretion | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Nasal congestion | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Oropharyngeal Pain | 2/10 (20%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Paranasal sinus hypersecretion | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 0/13 (0%) | ||||
| Pleuritic pain | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Sinus congestion | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Sneezing | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Upper-airway cough syndrome | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Skin and subcutaneous tissue disorders | ||||||||
| Cold sweat | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Cutis laxa | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Erythema | 1/10 (10%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Hyperhidrosis | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Night Sweats | 3/10 (30%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Rash | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Rash maculo-papular | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Skin hyperpigmentation | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Skin mass | 0/10 (0%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Skin ulcer | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
| Vascular disorders | ||||||||
| Deep vein thrombosis | 0/10 (0%) | 0/3 (0%) | 1/3 (33.3%) | 0/13 (0%) | ||||
| Haematoma | 1/10 (10%) | 0/3 (0%) | 0/3 (0%) | 2/13 (15.4%) | ||||
| Hot flush | 1/10 (10%) | 1/3 (33.3%) | 0/3 (0%) | 0/13 (0%) | ||||
| Hypotension | 0/10 (0%) | 0/3 (0%) | 0/3 (0%) | 1/13 (7.7%) | ||||
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Robert Janssen MD \ VP & Chief Medical Officer |
|---|---|
| Organization | Dynavax Technologies, Inc. |
| Phone | 510-665-0414 |
| rjanssen@dynavax.com |
- DV3-LYM-01