RecruitingPhase 2NCT07077512

Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma

A Single-arm, Phase II Clinical Study of Relmacabtagene Autoleucel Combined With Sintilimab for Relapsed/Refractory B-cell Lymphoma.


Sponsor

Sun Yat-sen University

Enrollment

30 participants

Start Date

Sep 15, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a prospective, single-arm, multicenter, phase II clinical trial to evaluate the efficacy and safety of Relmacabtagene Autoleucel in combination with the Sintilimab regimen for the treatment of relapsed/refractory B-cell lymphoma


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of relmacabtagene autoleucel (a CAR-T cell therapy targeting CD19) together with sintilimab (an immune checkpoint blocker) in patients with relapsed or refractory B-cell lymphoma, including diffuse large B-cell lymphoma, follicular lymphoma, and mantle cell lymphoma. **You may be eligible if...** - You are between 18 and 70 years old - You have been diagnosed with DLBCL, follicular lymphoma (FL), or mantle cell lymphoma (MCL) confirmed by biopsy with CD19-positive tumors - Your cancer has come back or not responded to prior treatment - You have at least one measurable or evaluable tumor - Your overall health is adequate (ECOG 0–2) and expected survival is at least 3 months - Your heart, lungs, liver, and kidneys are functioning adequately **You may NOT be eligible if...** - You are outside the 18–70 age range - Your tumors are CD19-negative - Your organ function does not meet the study requirements - Your overall health is too poor Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGAutoleucel (Relmacabtagene Autoleucel)

Relmacabtagene Autoleucel will be reinfused 2 to 7 days after lymphodepletion (fludarabine + cyclophosphamide).

DRUGSintilimab (PD-1 inhibitor)

Patients will receive intravenous Sintilimab (200 mg every 3 weeks) starting on Day 28 after reinfusion, continuing until disease progression or intolerable toxicity, with a maximum duration of 1 year.


Locations(3)

Sun Yat-sen Universitiy Cancer Center

Guangzhou, China

Fifth Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

Guangzhou overseas Chinese hospital

Guangzhou, China

View Full Details on ClinicalTrials.gov

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NCT07077512


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