Clinical Trial

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

Study acronym: DALY PED
Recruiting Phase 2
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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.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2024-07-17; most recent amendment 2026-05-04.
Status change: Not Yet Recruiting → Recruiting 2025-09-22
Trial Details
NCT Number NCT06508931
Lead Sponsor Miltenyi Biomedicine GmbH
Collaborators: PPD, Part of Thermo Fisher Scientific
Conditions B-Cell Neoplasm
Enrollment 31 participants
Start Date 2025-08-04
Primary Completion 2029-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-05-05