A Phase I/II Study of FG-M131 in TRBC1+ Relapsed/Refractory Peripheral T-Cell Lymphoma (NCT07758491) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
A Phase I/II Study of FG-M131 in TRBC1+ Relapsed/Refractory Peripheral T-Cell Lymphoma
China110 participantsStarted 2026-08-30
Plain-language 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.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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；
* Able to provide tumor tissue specimens;
* ECOG performance status of 0 or 1;
* Expected survival ≥3 months;
* Have at least one measurable tumor lesion;
* Adequate cardiac, bone marrow, liver, renal function;
Exclusion Criteria:
* 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;
* Have previously received any therapy targeting the TRBC1 antigen or any antibody-drug conjugate with MMAE payload;
* Have received autologous stem cell transplantation within 3 months prior to the first dose;
* Have previously received allogeneic stem cell transplantation;
* Have a history of other malignancies within 5 years prior to the first dose;
* Have received high-dose systemic vitamin A therapy (daily dose \>15,000 IU \[i.e., 5,000 mcg\]) within 3 weeks prior to the first dose of study drug;
* Have any condition …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.