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

July 29, 2024 updated by: TG Therapeutics, Inc.

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

21

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arkansas
      • Fayetteville, Arkansas, United States, 72703
        • TG Therapeutics Investigational Trial Site
    • New Jersey
      • Hackensack, New Jersey, United States, 07601
        • TG Therapeutics Investigational Trial Site
    • Tennessee
      • Chattanooga, Tennessee, United States, 37404
        • TG Therapeutics Investigational Trial Site
      • Nashville, Tennessee, United States, 37203
        • TG Therapeutics Investigational Trial Site
    • Texas
      • Houston, Texas, United States, 77030
        • TG Therapeutics Investigational Trial Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: TG-1801

TG-1801 Single Agent

As per protocol v3.0, Cohort A is no longer enrolling.
Biological: TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
Other Names:
  • NI-1701
Experimental: Cohort B: TG-1801
TG-1801 Single Agent, escalating doses
Biological: TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
Other Names:
  • NI-1701
Experimental: 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.
Biological: TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
Other Names:
  • NI-1701
Biological: Ublituximab
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks
Other Names:
  • TG-1101
  • LFB-R603

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

TG Therapeutics, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 28, 2021

Primary Completion (Actual)

June 12, 2024

Study Completion (Actual)

June 12, 2024

Study Registration Dates

First Submitted

March 5, 2021

First Submitted That Met QC Criteria

March 16, 2021

First Posted (Actual)

March 19, 2021

Study Record Updates

Last Update Posted (Actual)

July 31, 2024

Last Update Submitted That Met QC Criteria

July 29, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TG-1801-102

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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