PTCLPhase 1/2NCT07758491
A Phase I/II Study of FG-M131 in TRBC1+ Relapsed/Refractory Peripheral T-Cell Lymphoma
A Phase 1/2 study testing FG-M131 in people with PTCL and TRBC1 ADC, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- What is being tested?
- FG-M131
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteChina
- Study dates
- 30 Aug 2026to Apr 2031
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- Expected survival ≥3 months;
- Have at least one measurable tumor lesion;
- Adequate cardiac, bone marrow, liver, renal function;
Who cannot join
- 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;
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- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing Cancer Hospital
Beijing
Yuqin Song, +8610-88196118, SongYQ_VIP@163.com
About this study
Official title: An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M131 in Patients With TRBC1-positive Relapsed/Refractory Peripheral T-cell Lymphoma
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.
- Being tested
- FG-M131
- Keywords
- PTCL, TRBC1 ADC, CTCL
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FG-M131Drug
Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles)
FG-M131Drug
1~2 dose levels of FG-M131 will be tested according to the result from dose escalation stage
| Study group | Role | What they receive |
|---|---|---|
| FG-M131 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. Receives: Drug: FG-M131 |
| 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. Receives: Drug: FG-M131 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessed by Adverse Events (AEs)
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: Up to 24 months
Maximum Tolerated Dose (MTD)
MTD
Measured: 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.
Measured: 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
Measured: Up to 24 months
Secondary outcomes (7)
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).
Measured: Up to 24 months
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).
Measured: Up to 24 months
Overall Survival (OS)
OS is defined as the time from randomization to deathdue to any cause.
Measured: Up to 24 months
Maximum measured plasma concentration of FG-M131
Cmax
Measured: Up to 24 months
Time to maximum plasma concentration of FG-M131
Tmax
Measured: Up to 24 months
Half-life of FG-M131
T1/2
Measured: Up to 24 months
ADA
Incidence of anti-FG-M131 antibody and/or neutralizing antibody positivity
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Aug 2026
- Study start30 Aug 2026 (estimated)
- Primary completionJan 2031 (estimated)
- Study completionApr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTCLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07758491
- Sponsor's protocol ID
- FG-M131-01
- Status last verified
- Aug 2026
- First submitted
- 6 Aug 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multicenter Phase I/II Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of FG-M131 in Patients With TRBC1-positive Relapsed/Refractory Peripheral T-cell Lymphoma
- ClinicalTrials.gov ID
- NCT07758491
- Acronym / sponsor ID
- FG-M131-01
- Keywords
- PTCL, TRBC1 ADC, CTCL
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- FutureGen Biopharmaceutical (Beijing) Co., LtdIndustry (pharma, biotech, devices)
- Study start
- 30 Aug 2026 (estimated)
- Primary completion
- Jan 2031 (estimated)
- Study completion
- Apr 2031 (estimated)
- First posted
- 11 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FG-M131 Dose Escalation Cohort | Experimental | Drug: FG-M131Dose Escalation Cohort Eight dose levels of FG-M131 will be tested according to an accelerated titration method followed by a adaptive BOIN design. |
| FG-M131 Dose Expansion Cohort | Experimental | Drug: FG-M131Once the effective dose has been determined, 2 expansion cohorts will be opened to evaluate the efficacy and safety of the selected dose. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FG-M131Accelerated titration method, IV infusion Q3W; Adaptive BOIN design, IV infusion Q3W. (21-day cycles) | Drug | FG-M131 Dose Escalation Cohort |
| FG-M1311~2 dose levels of FG-M131 will be tested according to the result from dose escalation stage | Drug | FG-M131 Dose Expansion Cohort |
Primary outcome
Safety assessed by Adverse Events (AEs)
Time frame: Up to 24 months
Incidence and severity of adverse events (AEs) graded by Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Maximum Tolerated Dose (MTD)
Time frame: 21 days
MTD
Objective Response Rate (ORR)
Time frame: Up to 24 months
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)
Time frame: Up to 24 months
CRR is defined as the proportion of participants who have a best overall response of Complete Response (CR) as assessed by investigator evaluation
7 secondary outcomes
Progression Free Survival (PFS)
Time frame: Up to 24 months
Duration Of Response (DOR)
Time frame: Up to 24 months
Overall Survival (OS)
Time frame: Up to 24 months
Maximum measured plasma concentration of FG-M131
Time frame: Up to 24 months
Time to maximum plasma concentration of FG-M131
Time frame: Up to 24 months
Half-life of FG-M131
Time frame: Up to 24 months
ADA
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing FG-M131 in people with PTCL and TRBC1 ADC, run by FutureGen Biopharmaceutical (Beijing) Co., Ltd at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhaoyu Jin (+8610-60709130, pr@futuregenbiopharm.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety assessed by Adverse Events (AEs) (time frame: Up to 24 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.