Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

TG Therapeutics

Status and phase: Terminated; Phase 1

Conditions: Richter's Transformation; B-cell Non Hodgkin Lymphoma

Treatments: Drug: Cosibelimab; Drug: Cosibelimab + Ublituximab + Bendamustine combination

Study type: Interventional

Funder types: Industry

Identifiers

NCT03778073

TG-1501-101

Details and patient eligibility

About

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

Full description

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

Enrollment: 18 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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18 participants in 3 patient groups

Cohort A

Experimental group

Description:

Cosibelimab (TG-1501) single-agent

Treatment:

Drug: Cosibelimab

Cohort B

Experimental group

Description:

Cosibelimab + Ublituximab + Bendamustine combination

Treatment:

Drug: Cosibelimab + Ublituximab + Bendamustine combination

Drug: Cosibelimab + Ublituximab + Bendamustine combination

Cohort C

Experimental group

Description:

Cosibelimab + Ublituximab + Bendamustine combination

Treatment:

Drug: Cosibelimab + Ublituximab + Bendamustine combination

Drug: Cosibelimab + Ublituximab + Bendamustine combination