Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

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

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03778073

Enrollment

Registered

2018-12-19

Start date

2019-04-17

Completion date

2022-08-01

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

B-cell Non Hodgkin Lymphoma, Richter's Transformation

Keywords

relapsed or refractory

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.

Interventions

DRUGCosibelimab

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

DRUGCosibelimab + 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.

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion 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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Overall Response Rate	Up to 12 months	Objective response in subjects treated with interventions

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026