RecruitingPhase 2NCT06508931

Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms

A Single-arm, Multi-center, Open-label Phase II Study to Determine the Safety and Efficacy of MB-CART2019.1 in Pediatric Subjects With Relapsed/Refractory Mature B-cell Neoplasms Who Have Relapsed After One or More Prior Therapies, Including Subjects With Primary Refractory Disease


Sponsor

Miltenyi Biomedicine GmbH

Enrollment

31 participants

Start Date

Aug 4, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single-arm, multi-center, open-label Phase II study to determine the safety and efficacy of MB-CART2019.1 in pediatric and adolescent subjects (aged between 6 months and \<18 years, ≥6 kg body weight \[BW\]) with mature B-cell neoplasms and aggressive lymphomas that relapsed after or are refractory to one or more prior therapies, including subjects with primary refractory disease.


Eligibility

Min Age: 6 MonthsMax Age: 17 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a CAR T-cell therapy called zamtocabtagene autoleucel (MB-CART2019.1) in children and young adults whose B-cell blood cancers — such as certain types of leukemia or lymphoma — have come back or stopped responding to other treatments. CAR T-cell therapy uses the patient's own immune cells, which are modified in a lab to find and attack cancer cells. **You may be eligible if...** - You are a child or young adult (age requirements based on local regulations) - You have been diagnosed with a relapsed or refractory CD19+ and/or CD20+ B-cell cancer (such as Burkitt lymphoma, diffuse large B-cell lymphoma, or other aggressive B-cell cancers) - Your cancer has come back or has not responded to prior treatment - A parent or guardian can provide consent on your behalf if needed **You may NOT be eligible if...** - Your cancer does not express CD19 or CD20 - You have severe organ problems or active uncontrolled infections - You have certain other medical conditions that make this therapy unsafe 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

DRUGzamtocabtagene autoleucel (MB-CART2019.1)

Tandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy.


Locations(1)

Institut Gustave Roussy

Villejuif, France

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NCT06508931


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