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New combo therapy aims to beat back tough lymphomas

NCT ID NCT07077512

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial is testing a combination of two drugs—a CAR-T cell therapy (relmacabtagene autoleucel) and a PD-1 inhibitor (sintilimab)—in 30 adults with relapsed or refractory B-cell lymphoma. The goal is to see if the combo can shrink tumors and improve survival. Participants receive the CAR-T infusion first, then start the PD-1 inhibitor about a month later, continuing for up to a year.

What this could mean

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

Active substance
CAR-T cell therapy (relmacabtagene autoleucel) plus a PD-1 inhibitor (sintilimab)
What this could lead to
If successful, this combination could offer a new treatment option for patients with hard-to-treat B-cell lymphomas that have not responded to standard therapies.
What could go wrong
This is a small, early-phase trial with only 30 participants, so results may not apply to everyone. Side effects from CAR-T therapy and PD-1 inhibitors can be serious, including immune reactions and organ inflammation.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 30 people

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

Started

Sep 2025

Expected to finish

Jul 2027

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

18 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: 1. The patient must be aware of and voluntarily sign the informed consent form (ICF). 2. Aged between 18 and 70 years, both male and female. 3. Pathologically diagnosed with DLBCL, FL, or MCL, with histological confirmation of CD19 positivity (immunohistochemistry or flow cytometry, with flow cytometry used for re-evaluation if immunohistochemistry is CD19-negative). 4. The patient must be willing to receive regorafenib and sintilimab treatment and be deemed suitable for this treatment by the investigator. 5. Relapsed/refractory DLBCL, FL, or MCL. 6. At least one measurable or evaluable lesion. 7. Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 8. Expected survival of ≥3 months. 9. Adequate function of the heart, lungs, liver, kidneys, and other organs. Exclusion Criteria: 1. History of another malignancy that has not been in complete remission for at least 2 years, except for: non-melanoma skin cancer, completely resected stage I tumors with low recurrence potential, treated localized prostate cancer, biopsy-confirmed cervical carcinoma in situ, or squamous intraepithelial lesions detected by Pap smear and so on. 2. Active Hepatitis B: a) Positive for Hepatitis B surface antigen (HBsAg) and/or Hepatitis B core antibody (HBcAb) , with HBV-DNA below the lower limit of the reference value can be included. 3. Hepatitis C, HIV, or syphilis infection. 4. Uncontrolled systemic fungal, bacterial, viral, or other infections. 5. Acute or chronic graft-versus-host disease (GVHD). 6. Known hypersensitivity or allergy to any study drug or excipient. 7. Clinically significant central nervous system (CNS) disease or symptoms, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric illness. 8. Pregnant or breastfeeding women, and women of childbearing age who do not wish to use contraception. 9. Mentally ill individuals or those unable to provide informed consent. 10. The investigator deems the patient unsuitable for the study due to medical, psychological, familial, social, or geographical reasons or an inability to comply with the study protocol. 11. Previous CAR-T cell therapy or other gene-modified T-cell treatments. 12. Previous CD19-targeted therapy. 13. Previous allogeneic hematopoietic stem cell transplantation.

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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

    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

  • Fifth Affiliated Hospital of Guangzhou Medical University

    NOT_YET_RECRUITING

    Guangzhou, 510060, China

  • Guangzhou overseas Chinese hospital

    NOT_YET_RECRUITING

    Guangzhou, 510632, China

  • Sun Yat-sen Universitiy Cancer Center

    RECRUITING

    Guangzhou, 51000, China

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