Clinical Trials /

Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

NCT04806035

Description:

A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination with Ublituximab in Subjects with B-Cell Lymphoma or Chronic Lymphocytic Leukemia

Related Conditions:
  • B-Cell Non-Hodgkin Lymphoma
  • Chronic Lymphocytic Leukemia
  • Richter Syndrome
  • Transformed Non-Hodgkin Lymphoma
Recruiting Status:

Recruiting

Phase:

Phase 1

Trial Eligibility

Document

Title

  • Brief Title: Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
  • Official Title: A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia

Clinical Trial IDs

  • ORG STUDY ID: TG-1801-102
  • NCT ID: NCT04806035

Conditions

  • CLL
  • SLL
  • Richter's Transformation
  • Indolent Lymphoma
  • Follicular Lymphoma
  • Marginal Zone Lymphoma
  • Aggressive Lymphoma
  • DLBCL
  • Mediastinal Large B-cell Lymphoma
  • MCL

Interventions

DrugSynonymsArms
TG-1801NI-1701TG-1801
UblituximabTG-1101, LFB-R603TG-1801 + Ublituximab

Purpose

A Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination with Ublituximab in Subjects with B-Cell Lymphoma or Chronic Lymphocytic Leukemia

Trial Arms

NameTypeDescriptionInterventions
TG-1801ExperimentalTG-1801 Single Agent
  • TG-1801
TG-1801 + UblituximabExperimentalTG-1801 in combination with ublituximab
  • TG-1801
  • Ublituximab

Eligibility Criteria

        Inclusion Criteria:

          -  B-cell non-Hodgkin lymphoma (NHL) including RT and transformed FL, that warrants
             systemic therapy

          -  Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by iwCLL
             (Hallek 2018)

          -  Treatment Status:

               1. NHL subjects: relapsed to or refractory after at least two prior standard
                  systemic therapies (excluding antibiotics)

               2. RT subjects: must have relapsed after or be refractory to at least two prior line
                  of therapy for CLL/SLL or RT

               3. CLL subjects: relapsed to or refractory after at least two prior standard
                  therapies

          -  Measurable disease defined as:

               1. NHL (including SLL): at least 1 measurable disease lesion > 1.5 cm

               2. CLL: at least 1 measurable disease lesion

        Exclusion Criteria:

          -  Prior therapy with any agent blocking the CD47/SIRPα pathway or any previous CD19
             targeting therapy,

          -  Subjects receiving cancer therapy (i.e. chemotherapy, radiation therapy,
             immunotherapy, biologic therapy, hormonal therapy, surgery and/or tumor embolization)
             or any investigational drug within 21 days of Day 1 of Cycle 1

          -  Prior autologous SCT within 6 months.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:RP2D
Time Frame:24 months
Safety Issue:
Description:To determine the recommended Phase 2 dose (RP2D)

Secondary Outcome Measures

Measure:Overall Response Rate
Time Frame:24 months
Safety Issue:
Description:To evaluate the overall response rate (ORR) of TG-1801 alone and in combination with ublituximab

Details

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

Last Updated

August 23, 2021