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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-28

Study Completion Date

2024-06-12

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.

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Detailed Description

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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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort A: TG-1801

TG-1801 Single Agent

As per protocol v3.0, Cohort A is no longer enrolling.

Group Type EXPERIMENTAL

TG-1801

Intervention Type BIOLOGICAL

It is a bispecific, first-in-class, CD47 and CD19 antibody

Cohort B: TG-1801

TG-1801 Single Agent, escalating doses

Group Type EXPERIMENTAL

TG-1801

Intervention Type BIOLOGICAL

It is a bispecific, first-in-class, CD47 and CD19 antibody

Cohort C: TG-1801 + Ublituximab

TG-1801 in combination with ublituximab

As per protocol v3.0, ublituximab will be discontinued and the Cohort C is no longer enrolling.

Group Type EXPERIMENTAL

TG-1801

Intervention Type BIOLOGICAL

It is a bispecific, first-in-class, CD47 and CD19 antibody

Ublituximab

Intervention Type BIOLOGICAL

recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks

Interventions

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TG-1801

It is a bispecific, first-in-class, CD47 and CD19 antibody

Intervention Type BIOLOGICAL

Ublituximab

recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks

Intervention Type BIOLOGICAL

Other Intervention Names

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NI-1701 TG-1101 LFB-R603

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:

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No