About this trial
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.
Eligibility criteria
Qualifiers
Voluntarily sign the informed consent form, understand the study, are willing to comply with and have the ability to complete all trial procedures;
Age 18-75 years (inclusive), any gender;
Histologically and/or cytologically confirmed peripheral T-cell lymphoma or cutaneous T-cell lymphoma;
Relapsed or refractory lymphoma after at least one prior line of therapy；
Disqualifiers
Have received a live vaccine within 3 months prior to the first dose;
Have received radiotherapy within 4 weeks prior to the first dose;
Have received other anti-tumor drug therapy within 3 weeks or within 5 half-lives of the anti-tumor drug prior to the first dose;
Have undergone major surgery within 4 weeks prior to the first dose;
Trial design
Treatments tested in this trial
- FG-M131
- FG-M131