RecruitingPhase 2NCT06695013

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk R/R B-NHL

Immunobridging/Maintenance Therapy Versus Non-bridging Therapy in CAR-T Therapy for Low-risk Relapsed/Refractory B Cell Non-Hodgkin Lymphoma(R/R B-NHL): A Multicenter, Prospective, Randomized, Open-label, Controlled Clinical Study


Sponsor

Ruijin Hospital

Enrollment

144 participants

Start Date

Nov 20, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to explore whether adding immunotherapy bridging treatment for low-risk refractory/relapsed B-NHL can demonstrate better outcomes, in order to find the most effective treatment plan for low-risk patients.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two approaches before CAR-T cell therapy — a cutting-edge cancer treatment where a patient's own immune cells are modified to attack cancer — in patients with relapsed or refractory B-cell non-Hodgkin's lymphoma. One approach uses bridging immunotherapy to keep the disease under control while CAR-T cells are being made; the other skips that bridging therapy. **You may be eligible if...** - You are 18 or older - You have B-cell non-Hodgkin's lymphoma confirmed by biopsy, and it has relapsed or not responded to at least one prior treatment including standard chemotherapy and an anti-CD20 drug - You have not previously received CAR-T cell therapy targeting CD19 - Your organs are functioning well enough to tolerate the treatment - You have sufficient vein access for the cell collection procedure (leukapheresis) **You may NOT be eligible if...** - You have had an allogeneic bone marrow transplant (donor transplant) - You have a history of epilepsy, stroke, dementia, or autoimmune neurological disease - You have another active cancer (with limited exceptions) - You have serious heart failure (NYHA class III–IV) or a heart ejection fraction below 50% - You are allergic to the study treatment components 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

DRUGzanubrutinib

zanubrutinib 160 mg BID orally

DRUGCAR-T

CAR-T Cell therapy

RADIATIONBridging radiotherapy

For patients in the experimental group, the decision regarding radiotherapy will depend on whether the specific lesions are suitable.

DRUGTislelizumab

200mg IV Q3-4W


Locations(1)

Ruijin

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

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Visit

NCT06695013


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