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Can a smart drug spare healthy cells while killing lymphoma?

NCT ID NCT07758491

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Sep 03, 2026 · Updated 3 times

Summary

This trial is testing an experimental drug called FG-M131 in people with a type of blood cancer called peripheral T-cell lymphoma that has come back or not responded to prior treatment. FG-M131 is designed to target and destroy cancerous T cells that carry a marker called TRBC1, while leaving healthy T cells with a different marker (TRBC2) mostly unharmed. The study has two parts: first, to find the safest dose, and second, to see how well it shrinks tumors. The goal is to learn whether this targeted approach is safe and shows promise against this hard-to-treat cancer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
FG-M131, an antibody-drug conjugate that targets TRBC1 on malignant T cells
What this could lead to
If successful, this could lead to a new targeted treatment option for people with relapsed or refractory T-cell lymphoma, potentially improving response rates and survival.
What could go wrong
This is an early-phase trial, so safety and effectiveness are not yet established. The drug may cause side effects or may not work for all patients.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 110 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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;

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Beijing Cancer Hospital

    Beijing, China

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Other studies related to the condition(s) this trial covers.