Description:
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.
Clinical Trials /
Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
NCT03778073
Related Conditions:
- B-Cell Non-Hodgkin Lymphoma
Recruiting Status:
Recruiting
Phase:
Phase 1
Trial Eligibility
Document
Title
- Brief Title: Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma
- Official Title: A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma
Clinical Trial IDs
- ORG STUDY ID: TG-1501-101
- NCT ID: NCT03778073
Conditions
- B-cell Non Hodgkin Lymphoma
- Richter's Transformation
Interventions
| Drug | Synonyms | Arms |
|---|---|---|
| Cosibelimab | Cohort A | |
| Cosibelimab + Ublituximab + Bendamustine combination | Cohort B | |
| Cosibelimab + Ublituximab + Bendamustine combination | Cohort C |
Purpose
Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or
refractory B-cell Non Hodgkin's Lymphoma.
Detailed Description
This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent
cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.
Trial Arms
| Name | Type | Description | Interventions |
|---|---|---|---|
| Cohort A | Experimental | Cosibelimab (TG-1501) single-agent |
|
| Cohort B | Experimental | Cosibelimab + Ublituximab + Bendamustine combination |
|
| Cohort C | Experimental | Cosibelimab + Ublituximab + Bendamustine combination |
|
Eligibility Criteria
Key Inclusion Criteria:
- Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
- Measurable disease and adequate organ function as specified in the protocol
Key Exclusion Criteria:
- Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, or prior therapy with
bendamustine.
- Subjects receiving cancer therapy or investigational drug within 21 days of Cycle 1
Day 1.
- Prior autologous stem cell transplant within 3 months
- Active Hepatitis B or Hepatitis C
| Maximum Eligible Age: | N/A |
| Minimum Eligible Age: | 18 Years |
| Eligible Gender: | All |
| Healthy Volunteers: | No |
Primary Outcome Measures
| Measure: | Adverse Events That Are Related to Treatment |
| Time Frame: | 6 months of therapy |
| Safety Issue: | |
| Description: | Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities |
Secondary Outcome Measures
| Measure: | Overall Response Rate |
| Time Frame: | Up to 12 months |
| Safety Issue: | |
| Description: | Objective response in subjects treated with interventions |
Details
| Phase: | Phase 1 |
| Primary Purpose: | Interventional |
| Overall Status: | Recruiting |
| Lead Sponsor: | TG Therapeutics, Inc. |
Trial Keywords
- relapsed or refractory
Last Updated
August 23, 2021
