NCT06508931 Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
| NCT ID | NCT06508931 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Miltenyi Biomedicine GmbH |
| Condition | B-Cell Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 31 participants |
| Start Date | 2025-08-04 |
| Primary Completion | 2029-12-31 |
Trial Parameters
Eligibility Fast-Check
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Brief 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 Criteria
Inclusion Criteria: 1. Is able to provide age-appropriate assent/consent (as applicable, according to local legislation) and/or have a guardian able to provide consent signed and dated by the parent(s) or by subject's legal guardian before conduct of any study-specific procedures. 2. Has histologically confirmed mature CD19+ and/or CD20+ B-cell neoplasm such as: * Burkitt lymphoma/Burkitt leukemia * Diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS) * Primary mediastinal (thymic) large B-cell lymphoma * Burkitt-like lymphoma with 11q aberration * Aggressive mature B-cell lymphoma * Other rare aggressive B-cell non-Hodgkin lymphoma (NHL) after sponsor approval. 3. Has r/r B-cell neoplasms after one or more prior therapies or primary refractory to first-line therapy. 4. Is a pediatric/adolescent (aged between 6 months and \<18 years). 5. Has a BW of ≥ 6 kg. 6. Measurable disease based on the International Pediatric NHL Response Criteria (which refers to the Lugano crite