Brief Summary

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

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P25-P50 for phase_1

Timeline

Completed

Started Apr 2019

Typical duration for phase_1

Geographic Reach

1 country

9 active sites

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.3 years study duration

First Submitted

Initial submission to the registry

December 11, 2018

Completed

8 days until next milestone

First Posted

Study publicly available on registry

December 19, 2018

Completed

4 months until next milestone

Study Start

First participant enrolled

April 17, 2019

Completed

3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2022

Completed

3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2022

Completed

Last Updated

August 22, 2022

Status Verified

August 1, 2022

Enrollment Period

3 years

First QC Date

December 11, 2018

Last Update Submit

August 19, 2022

Conditions

B-cell Non Hodgkin Lymphoma Richter's Transformation

Keywords

relapsed or refractory

Outcome Measures

Primary Outcomes (1)

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 Outcomes (1)

Overall Response Rate
Up to 12 months

Study Arms (3)

Cohort A

EXPERIMENTAL

Cosibelimab (TG-1501) single-agent

Drug: Cosibelimab

Cohort B

EXPERIMENTAL

Cosibelimab + Ublituximab + Bendamustine combination

Drug: Cosibelimab + Ublituximab + Bendamustine combination

Cohort C

EXPERIMENTAL

Cosibelimab + Ublituximab + Bendamustine combination

Drug: Cosibelimab + Ublituximab + Bendamustine combination

Interventions

CosibelimabDRUG

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

Cohort A

Cosibelimab + Ublituximab + Bendamustine combinationDRUG

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 B

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.