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A Phase I/II Study of FG-M131 in TRBC1+ Relapsed/Refractory Peripheral T-Cell Lymphoma
Sponsor: FutureGen Biopharmaceutical (Beijing) Co., Ltd
Summary
FG-M131 for injection is an antibody-drug conjugate (ADC) targeting the T-cell receptor beta chain constant region 1 (TRBC1). TRBC1 is a subunit of the αβ T-cell receptor (TCR) complex. Targeting TRBC1 can eliminate TRBC1-positive malignant T cells while sparing TRBC2-positive normal T cells, providing a novel strategy for the treatment of T-cell malignancies. This study is a multicenter, open-label Phase I/II clinical trial in patients with TRBC1-positive relapsed/refractory peripheral T-cell lymphoma, designed to evaluate the safety, tolerability, pharmacokinetic profile, and preliminary antitumor activity of FG-M131 for injection in this patient population. The study consists of a Phase I dose-escalation stage and a Phase IIa cohort-expansion stage.
Official title: An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M131 in Patients With TRBC1-positive Relapsed/Refractory Peripheral T-cell Lymphoma
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
110
Start Date
2026-08-30
Completion Date
2031-04
Last Updated
2026-08-11
Healthy Volunteers
No
Interventions
FG-M131
Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
FG-M131
1\~2 dose levels of FG-M131 will be tested according to the result from dose escalation stage
Locations (1)
Beijing Cancer Hospital
Beijing, China