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

Study Overview
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Brief Summary
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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.

Official Title
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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

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

Intervention / Treatment
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* Biological: TG-1801
* Biological: Ublituximab


Participation Criteria
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Eligibility Criteria
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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: NHL subjects: relapsed to or refractory after at least two prior standard systemic therapies (excluding antibiotics) RT subjects: relapsed or refractory after at least two prior lines of therapy for CLL/ Small lymphocytic lymphoma (SLL) or RT CLL subjects: relapsed to or refractory after at least two prior standard therapies Measurable disease defined as: NHL (including SLL): at least 1 measurable disease lesion > 1.5 centimeters (cm) 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort A: TG-1801<br>TG-1801 Single Agent As per protocol v3.0, Cohort A is no longer enrolling. | Biological: TG-1801<br>* It is a bispecific, first-in-class, CD47 and CD19 antibody<br>* Other names: NI-1701;|
| Experimental: Cohort B: TG-1801<br>TG-1801 Single Agent, escalating doses | Biological: TG-1801<br>* It is a bispecific, first-in-class, CD47 and CD19 antibody<br>* Other names: NI-1701;|
| Experimental: Cohort C: TG-1801 + Ublituximab<br>TG-1801 in combination with ublituximab As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling. | Biological: TG-1801<br>* It is a bispecific, first-in-class, CD47 and CD19 antibody<br>* Other names: NI-1701;Biological: Ublituximab<br>* recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks<br>* Other names: LFB-R603;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RP2D | To determine the recommended Phase 2 dose (RP2D) | Up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate | To evaluate the overall response rate (ORR) of TG-1801 | Up to 24 months |