Clinical Trials /

Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma

NCT03778073

Description:

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

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Classical Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma
  • Official Title: A Phase 1 Study of TG-1501 in Subjects With Relapsed or Refractory Lymphoma

Clinical Trial IDs

  • ORG STUDY ID: TG-1501-101
  • NCT ID: NCT03778073

Conditions

  • Classical Hodgkin Lymphoma
  • B-cell Non Hodgkin Lymphoma

Interventions

DrugSynonymsArms
TG-1501TG-1501

Purpose

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

Detailed Description

      Planned enrollment includes 3 subjects at each dose level. TG-1501 will be administered as a
      60-minute IV infusion at fixed dose levels on Days 1 and 15 of every 28-day cycle or only on
      Day 1 of every 28-day cycle.
    

Trial Arms

NameTypeDescriptionInterventions
TG-1501ExperimentalTG-1501 will be administered as a 60-minute intravenous infusion on Days 1 and 15 of every 28-day cycle or only on Day 1 of every 28-day cycle.
  • TG-1501

Eligibility Criteria

        Inclusion Criteria:

          -  Histologically confirmed relapsed or refractory classical Hodgkin lymphoma (cHL) or
             B-cell non-Hodgkin lymphoma (NHL).

          -  Measurable disease and adequate organ function as specified in the protocol

          -  Life expectancy of at least 3 months

        Exclusion Criteria:

          -  Prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, antibody, or any other
             antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint
             pathways.

          -  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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

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

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:Up to 12 months
Safety Issue:
Description:Objective response in subjects treated with TG-1501

Details

Phase:Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:TG Therapeutics, Inc.

Trial Keywords

  • relapsed or refractory

Last Updated

November 4, 2019