drugset / Trial / NCT06508931
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
Phase 2
Recruiting
31 enrolled
Miltenyi Biomedicine GmbH
PPD, Part of Thermo Fisher Scientific · collab
NaSingle-groupOpen-labelTreatment
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.
Timeline
- Start
- 2025-08-04
- Primary completion
- 2029-12-31
- Completion
- 2029-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | zamtocabtagene autoleucel | Cell therapy | 2.5e+06 cells/kg | — |