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

Phase 1

Terminated

• Conditions: Indolent Lymphoma; Follicular Lymphoma; DLBCL; SLL; Mediastinal Large B-cell Lymphoma; CLL; Richter's Transformation; Marginal Zone Lymphoma; Aggressive Lymphoma; MCL
• Interventions: Biological: TG-1801; Biological: Ublituximab

• Registration Number: NCT04806035
• Lead Sponsor: TG Therapeutics, Inc.

Brief Summary

The primary objective of this study is to determine the recommended phase 2 dose (RP2D) and characterize the safety profile of TG-1801. As per protocol v3.0, ublituximab will be discontinued.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-05
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-19
• Study Start: 2021-04-28
• Primary Completion: 2024-06-12
• Study Completion: 2024-06-12
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-29
• Last Update Posted: 2024-07-31

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• B-cell non-Hodgkin lymphoma (NHL) including Richter's Transformation (RT) and transformed follicular lymphoma (FL), that warrants systemic therapy

• Chronic Lymphocytic Leukemia (CLL), that warrants systemic therapy as defined by International Workshop on Chronic Lymphocytic Leukemia (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: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (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 centimeters (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 Cycle 1 Day 1.
• Prior autologous stem cell transplant (SCT) within 6 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort C: TG-1801 + Ublituximab	Ublituximab	TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.
Cohort A: TG-1801	TG-1801	TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.
Cohort B: TG-1801	TG-1801	TG-1801 Single Agent, escalating doses
Cohort C: TG-1801 + Ublituximab	TG-1801	TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.

Primary Outcome Measures

Name	Time	Method
RP2D	Up to 24 months	To determine the recommended Phase 2 dose (RP2D)

Secondary Outcome Measures

Name	Time	Method
Overall Response Rate	Up to 24 months	To evaluate the overall response rate (ORR) of TG-1801

Trial Locations

Locations (1)

TG Therapeutics Investigational Trial Site; 🇺🇸 Houston, Texas, United States