Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-04-17

Study Completion Date

2022-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Phase 1 open label, multi-center, dose-escalation study for individuals with relapsed or refractory B-cell Non Hodgkin's Lymphoma.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

NCT04806035

CLL SLL Richter's Transformation +7 more

TERMINATED PHASE1

Study of the Efficacy and Safety of Ublituximab in Patients With Relapsed or Refractory B-cell Non-Hodgkin Lymphoma

NCT01647971

Non-Hodgkins Lymphoma B-cell Lymphoma Waldenstrom's Macroglobulinemia +4 more

COMPLETED PHASE1/PHASE2

Study of Immunotherapy in Combination With Ublituximab and Umbralisib in Patients With Relapsed-refractory CLL or Richter's Transformation

NCT02535286

Chronic Lymphocytic Leukemia Richter Syndrome

COMPLETED PHASE1

Umbralisib and Rituximab as Initial Therapy for Patients With Follicular Lymphoma and Marginal Zone Lymphoma

NCT03919175

Lymphoma Follicular Lymphoma Follicular Lymphoma, Grade 1 +4 more

TERMINATED PHASE2

A Study Evaluating Safety and Efficacy of C-CAR011 in Subjects With B-NHL

NCT03299738

Refractory or Relapsed B-cell Non-Hodgkin Lymphoma

UNKNOWN PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

This study will evaluate the safety profile, pharmacokinetics, and efficacy of single-agent cosibelimab as well as the combination of Cosibelimab + Ublituximab + Bendamustin.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

B-cell Non Hodgkin Lymphoma Richter's Transformation

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Cohort A

Cosibelimab (TG-1501) single-agent

Group Type EXPERIMENTAL

Cosibelimab

Intervention Type DRUG

Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle

Cohort B

Cosibelimab + Ublituximab + Bendamustine combination

Group Type EXPERIMENTAL

Cosibelimab + Ublituximab + Bendamustine combination

Intervention Type DRUG

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.

Cohort C

Cosibelimab + Ublituximab + Bendamustine combination

Group Type EXPERIMENTAL

Cosibelimab + Ublituximab + Bendamustine combination

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cosibelimab

Intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle

Intervention Type DRUG

Cosibelimab + Ublituximab + Bendamustine combination

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.

Intervention Type DRUG

Cosibelimab + Ublituximab + Bendamustine combination

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Histologically confirmed relapsed or refractory B-cell non-Hodgkin lymphoma (NHL).
* Measurable disease and adequate organ function as specified in the protocol

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No