A Phase I/II Study of FG-M131 in TRBC1+ Relapsed/Refractory Peripheral T-Cell Lymphoma

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 requiring systemic treatment with corticosteroids (\>20 mg/day prednisone or equivalent) or other immunosuppressive agents within 14 days prior to the first dose;
* Have received oral retinoid drugs for any indication within 3 weeks prior to the first dose;
* Have adverse reactions from prior treatments that have not recovered to CTCAE v5.0 Grade ≤1 (excluding alopecia and anemia) prior to the first dose;
* Presence or history of central nervous system lymphoma, leptomeningeal disease, or spinal cord compression;
* Have a history of severe allergic reactions or are allergic to the investigational drug;
* Have experienced a clinically significant cardiac disease within 6 months before the first dose;
* Have uncontrolled systemic diseases assessed by the investigator, including diabetes, hypertension, pulmonary fibrosis, interstitial lung disease, etc.;
* Known history of Hepatitis C or chronic active Hepatitis B;
* Clinically uncontrolled diseases such as diabetes mellitus, thyroid disease, or other severe systemic diseases requiring systemic treatment;
* Active or progressive infection requiring systemic therapy within 2 weeks prior to the first dose;
* Known or suspected active autoimmune disease requiring systemic therapy within 2 years prior to the first dose;
* Are pregnant or breastfeeding;