Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Sponsor
ImmuneOnco Biopharmaceuticals (Shanghai) Inc. (Other)
Overall Status
Recruiting
CT.gov ID
NCT04746131
Collaborator
Worldwide Clinical Trials (Other)
90
1
1
38.8
2.3
Study Details
Study Description
Brief Summary
The purpose of this study is to assess the safety and efficacy of IMM0306-02 in patients with refractory or relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
90 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Safety and Pharmacokinetic Study of IMM0306 in Patients With Refractory or Relapsed CD20-positive B-cell Non-Hodgkin's Lymphoma (B-NHL)
Actual Study Start Date
:
Jan 15, 2021
Anticipated Primary Completion Date
:
Apr 11, 2024
Anticipated Study Completion Date
:
Apr 11, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: IMM0306 IMM0306 Dose escalation: 0.1mg/kg, 0.2mg/kg, 0.4mg/kg, 0.8mg/kg,1.2mg/kg and 1.6mg/kg through intravenous administration weekly up to 52 weeks. |
Drug: IMM0306
IMM0306 is an bi-specific antibody
|
Outcome Measures
Primary Outcome Measures
- Maximum Tolerated Dose (MTD) of IMM0306 as measured by incidence of DLTs (Dose Limiting Toxicity) [End of Study (52 Weeks)]
DLT is defined as one of the following toxicities occurring during the DLT assessment for Cycle 1.
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
18-75 years old
-
Diagnosed with B-NHL
-
Relapsed after or be refractory to at least 2 line of standard therapy
Exclusion Criteria:
-
Active central nervous system (CNS) metastases
-
Positive Direct Antiglobulin Test (DAT)
-
Active autoimmune disorder
-
Skin disorders that do not requires hormone replacement therapy
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Christ Hospital | Cincinnati | Ohio | United States | 45219 |
Sponsors and Collaborators
- ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
- Worldwide Clinical Trials
Investigators
- Study Director: Cheng Huang, MD, VP，Clinical Development
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
ClinicalTrials.gov Identifier:
NCT04746131
Other Study ID Numbers:
- IMM0306
First Posted:
Feb 9, 2021
Last Update Posted:
Apr 4, 2022
Last Verified:
Apr 1, 2022
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by ImmuneOnco Biopharmaceuticals (Shanghai) Inc.
Additional relevant MeSH terms: