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

NCT07758491 | Not Yet Recruiting Phase 1

• 1 other identifier: FG-M131-01
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

PTCL; TRBC1 ADC; CTCL

Keywords

PTCL; TRBC1 ADC; CTCL

Outcome Measures

Primary Outcomes (4)

• Safety assessed by Adverse Events (AEs)

  An AE is any adverse medical event that occurs during a clinical study, whether or not related with medicinal product, including signs, symptoms, abnormal laboratory test results and diseases. The incidence and severity of AEs during the clinical study are recorded and analyzed.

  Up to 24 months

• Maximum Tolerated Dose (MTD)

  MTD

  21 days

• 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.

  Up to 24 months

• 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

  Up to 24 months

Secondary Outcomes (7)

• Progression Free Survival (PFS)

  Up to 24 months

• Duration Of Response (DOR)

  Up to 24 months

• Overall Survival (OS)

  Up to 24 months

• Maximum measured plasma concentration of FG-M131

  Up to 24 months

• Time to maximum plasma concentration of FG-M131

  Up to 24 months

Study Arms (2)

Dose Escalation Cohort

EXPERIMENTAL

Dose Escalation Cohort Eight dose levels of FG-M131 will be tested according to an accelerated titration method followed by a adaptive BOIN design.

Drug: FG-M131

Dose Expansion Cohort

EXPERIMENTAL

Once the effective dose has been determined, 2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose.

Drug: FG-M131

Interventions

FG-M131 DRUG

Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)

Dose Escalation Cohort

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• FutureGen Biopharmaceutical (Beijing) Co., Ltd: lead

Study Sites (1)

Beijing Cancer Hospital

Beijing, China

Location

Central Study Contacts

Zhaoyu Jin

CONTACT

+8610-60709130; pr@futuregenbiopharm.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2026
• First Posted: August 11, 2026
• Study Start (Estimated): August 30, 2026
• Primary Completion (Estimated): January 1, 2031
• Study Completion (Estimated): April 1, 2031
• Last Updated: August 11, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)