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
This trial does not accept healthy volunteersQualifiers
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
Sequential
Treatments tested in this trial
FG-M131
DrugAccelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
FG-M131
Drug1\~2 dose levels of FG-M131 will be tested according to the result from dose escalation stage
Treatment groups
Trial outcomes
Primary outcomes
Safety assessed by Adverse Events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Maximum Tolerated Dose (MTD)
MTD
Objective Response Rate (ORR)
ORR is defined as the proportion of participants who have a best overall response of Complete Response (CR) or Partial Response (PR) as assessed by investigator evaluation.
Complete Response Rate (CRR)
CRR is defined as the proportion of participants who have a best overall response of Complete Response (CR) as assessed by investigator evaluation
Secondary outcomes
Progression Free Survival (PFS)
PFS is defined as the duration from randomization to the first imaging confirmation of progressive disease by investigator evaluation or death due to any cause (whichever occurs first).
Duration Of Response (DOR)
DOR is defined as the time from the date of the first response (CR/PR) until the date of progressive disease as assessed by investigator evaluation or death due to any cause (whichever occurs first).
Overall Survival (OS)
OS is defined as the time from randomization to deathdue to any cause.
Maximum measured plasma concentration of FG-M131
Cmax
Sponsors and contacts
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