RecruitingPhase 1NCT07108868

A Phase I Dose Finding Study of MB-CART2219.1

A Phase I Dose Finding Study of MB-CART2219.1 Targeting CD19/CD22 in Adult and Pediatric Patients With Relapsed/Refractory B-cell Malignancies


Sponsor

University Hospital Tuebingen

Enrollment

36 participants

Start Date

Jun 23, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

A Phase I dose finding study of MB-CART2219.1 targeting CD19/CD22 in adult and pediatric patients with relapsed/refractory B-cell malignancies


Eligibility

Min Age: 12 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This early-phase study is finding the right dose of MB-CART2219.1 — a dual-targeting CAR-T cell therapy that attacks both CD19 and CD22 proteins found on certain blood cancer cells. It is being tested in adults with lymphoma and in children/teenagers (12+) with B-cell acute lymphoblastic leukemia (B-ALL). **You may be eligible if (adults with lymphoma):** - You are 18 or older - Your cancer cells express CD19 or CD22 - You are able to follow study requirements and commit to 15-year follow-up (required by regulations for gene therapy) **You may be eligible if (pediatric B-ALL patients):** - You are 12 or older - You have B-cell acute lymphoblastic leukemia with CD19 or CD22 expression - Your parent or guardian has consented and you have also given assent **You may NOT be eligible if:** - Your cancer cells do not express CD19 or CD22 - You cannot commit to the required long-term follow-up - You have significant health conditions that would make this treatment 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

BIOLOGICALCAR-T cells targeting CD19 and CD22

Using the 3+3 design, the following dose levels will be assessed: Dose level 1: 0.5x10e6 CAR-transduced T cells/kg; Dose level 2: 1x10e6 CAR-transduced T cells/kg; Dose level 3: 2x10e6 CAR-transduced T cells/kg; Dose level 0: 0.25x10e6 CAR-transduced T cells/kg


Locations(2)

University Hospital , Department of Internal Medicine II

Tübingen, Baden-Wurttemberg, Germany

University Hospital, Clinic for Pediatric Medicine

Tübingen, Baden-Wurttemberg, Germany

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NCT07108868


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