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Study of Cosibelimab in Subjects With Relapsed or Refractory Lymphoma

NCT03778073 · Status: TERMINATED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2022-08-22

No results posted yet for this study

Summary

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

Conditions

  • B-cell Non Hodgkin Lymphoma
  • Richter's Transformation

Interventions

DRUG

Cosibelimab

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

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.

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.

Sponsors & Collaborators

  • TG Therapeutics, Inc.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-17
Primary Completion
2022-05-03
Completion
2022-08-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778073 on ClinicalTrials.gov