Suspended

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

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What is being tested

TG-1801

+ Ublituximab

Biological
Who is being recruted

Hemic and Lymphatic Diseases+9

+ Immune System Diseases

+ Immunoproliferative Disorders

Over 18 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 1
Interventional
Study Start: April 2021
See protocol details

Summary

Principal SponsorTG Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: April 28, 2021

Actual date on which the first participant was enrolled.

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 TitleA Phase 1b Multi-cohort Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
NCT04806035
Principal SponsorTG Therapeutics, Inc.
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

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

21 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Hemic and Lymphatic DiseasesImmune System DiseasesImmunoproliferative DisordersLymphatic DiseasesLymphomaLymphoma, FollicularLymphoma, Non-HodgkinLymphoproliferative DisordersNeoplasmsNeoplasms by Histologic TypeLymphoma, B-CellLymphoma, B-Cell, Marginal Zone

Criteria

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

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

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

Group II

Experimental
TG-1801 Single Agent, escalating doses

Group III

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

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Suspended

TG Therapeutics Investigational Trial Site

Fayetteville, United StatesOpen TG Therapeutics Investigational Trial Site in Google Maps
Suspended

TG Therapeutics Investigational Trial Site

Hackensack, United States
Suspended

TG Therapeutics Investigational Trial Site

Chattanooga, United States
Suspended

TG Therapeutics Investigational Trial Site

Nashville, United States
Suspended5 Study Centers