Study of TG-1801 Alone or in Combination With Ublituximab in Subjects With B-Cell Lymphoma or Chronic Lymphocytic Leukemia
Stopped early · Phase 1
Conditions studied: CLL, SLL, Richter's Transformation, Indolent Lymphoma, Follicular Lymphoma, Marginal Zone Lymphoma, Aggressive Lymphoma, DLBCL, Mediastinal Large B-cell Lymphoma, MCL
In brief
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.
Key facts
- Study ID
- NCT04806035
- Run by
- TG Therapeutics, Inc.
- People needed
- 21
- Starts
- 2021-04-28
- Expected to finish
- 2024-06-12
- Last updated by the study team
- 2024-07-31
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- TG Therapeutics Investigational Trial Site — Fayetteville, Arkansas, United States
- TG Therapeutics Investigational Trial Site — Hackensack, New Jersey, United States
- TG Therapeutics Investigational Trial Site — Chattanooga, Tennessee, United States
- TG Therapeutics Investigational Trial Site — Nashville, Tennessee, United States
- TG Therapeutics Investigational Trial Site — Houston, Texas, United States
Full record on ClinicalTrials.gov
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