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NCT04806035 Clinical Trial

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

Follicular Lymphoma Clinical Trial

Official title:
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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT04806035
Other study ID # TG-1801-102
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received
Last updated
Start date April 23, 2021
Est. completion date December 1, 2024

Study information
Verified date May 2024
Source TG Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 60
Est. completion date December 1, 2024
Est. primary completion date December 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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/SIRPa 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 Design

Related Conditions & MeSH terms

Intervention

Biological:
• TG-1801
It is a bispecific, first-in-class, CD47 and CD19 antibody
• Ublituximab
recombinant chimeric anti-CD20 monoclonal antibody, available in 25 mg/mL administered as an IV infusion once every 4 weeks

Locations
Country Name City State
United States TG Therapeutics Investigational Trial Site Chattanooga Tennessee
United States TG Therapeutics Investigational Trial Site Fayetteville Arkansas
United States TG Therapeutics Investigational Trial Site Hackensack New Jersey
United States TG Therapeutics Investigational Trial Site Houston Texas
United States TG Therapeutics Investigational Trial Site Nashville Tennessee

Sponsors (1)
Lead Sponsor Collaborator
TG Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary RP2D To determine the recommended Phase 2 dose (RP2D) Up to 24 months
Secondary Overall Response Rate To evaluate the overall response rate (ORR) of TG-1801 Up to 24 months
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