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

TG Therapeutics

Status and phase: Terminated; Phase 1

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

Treatments: Biological: Ublituximab; Biological: TG-1801

Study type: Interventional

Funder types: Industry

Identifiers

NCT04806035

TG-1801-102

Details and patient eligibility

About

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.

Enrollment: 21 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 3 patient groups

Cohort A: TG-1801

Experimental group

Description:

TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling.

Treatment:

Biological: TG-1801

Cohort B: TG-1801

Experimental group

Description:

TG-1801 Single Agent, escalating doses

Treatment:

Biological: TG-1801

Cohort C: TG-1801 + Ublituximab

Experimental group

Description:

TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.

Treatment:

Biological: TG-1801

Biological: Ublituximab