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;