Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
A Phase 1 Study of Cosibelimab (TG-1501) in Subjects With Relapsed or Refractory Lymphoma

Conditions
-----------------
B-cell Non Hodgkin Lymphoma, Richter's Transformation

Intervention / Treatment
-----------------
* Drug: Cosibelimab
* Drug: Cosibelimab + Ublituximab + Bendamustine combination
* Drug: Cosibelimab + Ublituximab + Bendamustine combination


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A<br>Cosibelimab (TG-1501) single-agent | Drug: Cosibelimab<br>* Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle<br>|
| Experimental: Cohort B<br>Cosibelimab + Ublituximab + Bendamustine combination | Drug: Cosibelimab + Ublituximab + Bendamustine combination<br>* Cosibelimab (Intravenous infusion): Cycle 1-6 Days 1&15, Cycles 7-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2&3, Cycles 2-6 Days 1&2.<br>|
| Experimental: Cohort C<br>Cosibelimab + Ublituximab + Bendamustine combination | Drug: Cosibelimab + Ublituximab + Bendamustine combination<br>* Cosibelimab (Intravenous infusion): Cycle 1-12 Day 1, Cycles 15-24 Day 1 every 3 cycles; Ublituximab (Intravenous infusion): Cycles 1-6 Day 1, Cycles 9-24 every 3 Cycles; Bendamustine (Intravenous infusion): Cycle 1 Days 2&3, Cycles 2-6 Days 1&2.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events That Are Related to Treatment | Number of Participants With Treatment-Related Adverse Events, any potential abnormal laboratory results and any dose-limiting toxicities | 6 months of therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | Objective response in subjects treated with interventions | Up to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapsed or refractory