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Engineered immune cells target CD5 in Hard-to-Treat T-Cell lymphomas

NCT ID NCT07022964

Cure Sponsor: Beijing GoBroad Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Last updated Sep 11, 2026

Summary

Researchers are testing a new immune cell therapy called CD5 CAR-T in people with mature T-cell lymphomas that have come back or stopped responding to standard treatment. The trial enrolls about 36 participants, ages 14 to 70, who have few remaining options. Participants receive an infusion of engineered immune cells designed to recognize and attack lymphoma cells that carry the CD5 protein. The main goal is to measure safety and dose-limiting side effects within the first three weeks, and to see how many participants respond to the treatment.

What this could mean

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

Active substance
CD5 CAR-T cells, a type of immune cell therapy engineered to target the CD5 protein on lymphoma cells
What this could lead to
If it works, this approach could offer a new treatment option for people with T-cell lymphomas that have stopped responding to standard therapy, and could help them reach a stem cell transplant.
What could go wrong
This is an early-phase trial with a small number of participants, so safety and effectiveness are still unknown. CAR-T therapies can cause serious side effects, and the treatment may not work for everyone.

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 36 people

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

Started

Jun 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

14 to 70 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 (Patients who met all the inclusion criteria were eligible for enrolment): * Relapsed or refractory CD7-positive T-cell lymphomas that were treated with with standard chemotherapy, with poor prognosis from currently available treatments at and no available treatment options (e.g., HSCT or chemotherapy); * Male or female, age 14-70; * Eastern Cooperative Oncology Group (ECOG) Physical Status Score 0-2; * life expectancy is at least 60 days; * Subjects should be capable of understanding and signing the informed consent form prior to any screening procedures. Subjects are willing to follow the study visit schedule and associated study procedures as specified in the protocol. Candidates between the ages of 19-70 years old will need to be sufficiently aware of and capable of signing the informed consent form; underage candidates between the ages of 14-18 years old will need to be sufficiently aware of the informed consent form and their legal guardian will also need to sign the informed consent form separately. Exclusion Criteria (Patients who fulfil any of the following criteria may not be enrolled): * Patients with history of allogeneic HSCT but PBMNC is not available from prior- transplant donor for preparation of CAR T cells and peripheral blood tumour load \>30%; patients without history of allogeneic HSCT and peripheral blood tumour load \>30%; * Intracranial hypertension or cerebral impaired consciousness; * Symptomatic heart failure or severe arrhythmia; * Symptoms of severe respiratory failure; * With other types of malignancy; * Diffuse intravascular coagulation; * Serum creatinine and/or urea nitrogen ≥ 1.5 times the normal value; * With sepsis or other uncontrollable infection; * Suffering from uncontrollable diabetes mellitus; * Severe mental disorders; * Have significant intracranial lesions on cranial MRI; * Organ transplantation (excluding haematopoietic stem cell transplantation) history; * Female patients (patients of childbearing potential) with positive blood HCG test; * Hepatitis (including hepatitis B and C) and positive screening for AIDS and syphilis.

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Conditions

The condition(s) this trial relates to.

mature T-cell and NK-cell non-Hodgkin lymphoma primary cutaneous T-cell non-Hodgkin lymphoma T-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

T-cell lymphoma (PTCL and CTCL) T-cell non-Hodgkin lymphoma

How to take part

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

  1. The places running it

    3 sites. 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 GoBroad Hospital

    RECRUITING

    Beijing, 102200, China

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    RECRUITING

    Shanghai, 200025, China

  • Shanghai Liquan Hospital

    RECRUITING

    Shanghai, 200435, China

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