CIVIC: Cellular Immunotherapy for Viral Induced Cancer - EBV Positive Lymphomas
Study Details
Study Description
Brief Summary
To investigate the efficacy of autologous Epstein-barr virus (EBV)-specific T cells for the treatment of EBV positive Diffuse Large B Cell Lymphoma (DLBCL), Hodgkin Lymphoma (HL) and Post-transplant Lymphoproliferative Disease (PTLD) after failing first line treatment.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: baltaleucel-T Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. |
Biological: baltaleucel-T
Autologous EBV-specific T cells
|
Outcome Measures
Primary Outcome Measures
- Best Overall Response [1 year]
Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up.
Secondary Outcome Measures
- Adverse Events [1 year]
Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration.
Eligibility Criteria
Criteria
Inclusion Criteria:
- The study will include three primary cohorts, with any of the following EBV+ diseases:
Cohort A - DLBCL, 1) in first or subsequent relapse, not eligible for autologous transplantation following salvage therapy OR 2) relapse following autologous transplantation.
Cohort B - HL, brentuximab vedotin (BV) treatment failure or unable to tolerate BV.
Cohort C - PTLD, rituximab treatment failure.
-
Presence of active lymphoma or active PTLD, based on imaging performed within the previous 3 months.
-
Tumor positive for EBV encoded RNA (EBER) based on report from certified laboratory.
-
Absolute lymphocyte count (ALC) >500/µL
-
Male or female ≥ 12 years of age
-
Weight ≥ 35 kg
-
Eastern Cooperative Oncology Group (ECOG) performance score 0-2, inclusively or Lansky score ≥ 60, as age appropriate
-
Able to understand and comply with the requirements of the study and to provide written informed consent or age appropriate assent for pediatric patients.
Exclusion Criteria:
-
Known central nervous system (CNS) lymphoma
-
Primary refractory HL or DLBCL
-
Bulky disease
-
Relapse or progression following previous autologous EBV specific T cell treatment.
-
Use of systemic corticosteroids > 0.5 mg/kg/day prednisolone or equivalent does of alternative corticosteroid within 10 days prior to obtaining 200 mL starting material
-
Positive for HIV, hepatitis B, hepatitis C, syphilis or human T cell leukemia virus (HTLV).
-
Patient is pregnant or lactating
-
Systemic fungal, bacterial, viral or other infection that is not controlled
-
Prior allogeneic hematopoietic stem cell transplantation (allo HSCT)
-
Known history of primary immunodeficiency
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | MD Anderson Cancer Center | Houston | Texas | United States | 77030 |
Sponsors and Collaborators
- Cell Medica Ltd
Investigators
- Study Director: Kurt Gunter, MD, Cell Medica, Inc
Study Documents (Full-Text)
More Information
Publications
None provided.- CM-2015-01
Study Results
Participant Flow
| Recruitment Details | Study was closed early due to inadequate recruitment. |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Baltaleucel-T |
|---|---|
| Arm/Group Description | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells |
| Period Title: Overall Study | |
| STARTED | 1 |
| COMPLETED | 0 |
| NOT COMPLETED | 1 |
Baseline Characteristics
| Arm/Group Title | Baltaleucel-T |
|---|---|
| Arm/Group Description | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells |
| Overall Participants | 1 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
1
100%
|
| >=65 years |
0
0%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
0
0%
|
| Male |
1
100%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
1
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
0
0%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
1
100%
|
| Region of Enrollment (participants) [Number] | |
| United States |
1
100%
|
| Cohort B - Hodgkin Lymphoma (HL) (Count of Participants) | |
| Count of Participants [Participants] |
1
100%
|
Outcome Measures
| Title | Best Overall Response |
|---|---|
| Description | Best single observed response, complete response (CR) or partial response (PR) per Lugano 2014 Disease Response Criteria, during 12 month follow-up. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| Subject was withdrawn early before first disease assessment timepoint. |
| Arm/Group Title | Balteleucel-T |
|---|---|
| Arm/Group Description | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. balteleucel-T: Autologous EBV-specific T cells |
| Measure Participants | 0 |
| Title | Adverse Events |
|---|---|
| Description | Adverse events will be recorded from the time of the first investigational cell product dose is administered until 30 days after the last administration. Serious events recorded for up to 1 year after administration. |
| Time Frame | 1 year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Balteleucel-T |
|---|---|
| Arm/Group Description | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. balteleucel-T: Autologous EBV-specific T cells |
| Measure Participants | 1 |
| Count of Participants [Participants] |
1
100%
|
Adverse Events
| Time Frame | 1 month | |
|---|---|---|
| Adverse Event Reporting Description | Prescheduled hospital admissions, hospital admissions for elective surgery, transfusions, diagnostic procedures are not considered to be SAEs. Events related to progression of the underlying malignancy will likewise not be categorized as serious. | |
| Arm/Group Title | Baltaleucel-T | |
| Arm/Group Description | Treatment consist of up to 5 doses of 2x10E7 cells/m2 administered intravenously every 2 weeks. baltaleucel-T: Autologous EBV-specific T cells | |
All Cause Mortality |
||
| Baltaleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | |
Serious Adverse Events |
||
| Baltaleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | |
| Blood and lymphatic system disorders | ||
| Hemophagocytic Lymphohistiosytosis | 1/1 (100%) | 1 |
| Immune system disorders | ||
| Cytokine Release Syndrome | 1/1 (100%) | 1 |
Other (Not Including Serious) Adverse Events |
||
| Baltaleucel-T | ||
| Affected / at Risk (%) | # Events | |
| Total | 1/1 (100%) | |
| Blood and lymphatic system disorders | ||
| Anemia | 1/1 (100%) | 2 |
| General disorders | ||
| Fatigue | 1/1 (100%) | 1 |
| Investigations | ||
| Platelet Count Decreased | 1/1 (100%) | 1 |
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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Kurt Gunter (Chief Medical Officer) |
|---|---|
| Organization | Cell Medica |
| Phone | 832-581-4480 |
| Kurt.Gunter@cellmedica.com |
- CM-2015-01