Status:
TERMINATED
Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
Lead Sponsor:
TG Therapeutics, Inc.
Conditions:
CLL
SLL
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief 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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 12 2024
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT04806035
Start Date
April 28 2021
End Date
June 12 2024
Last Update
July 31 2024
Active Locations (5)
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1
TG Therapeutics Investigational Trial Site
Fayetteville, Arkansas, United States, 72703
2
TG Therapeutics Investigational Trial Site
Hackensack, New Jersey, United States, 07601
3
TG Therapeutics Investigational Trial Site
Chattanooga, Tennessee, United States, 37404
4
TG Therapeutics Investigational Trial Site
Nashville, Tennessee, United States, 37203