MedTrace Logo

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

NCT06508931 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2026-05-05

No results posted yet for this study

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.

Conditions

  • B-Cell Neoplasm

Interventions

DRUG

zamtocabtagene autoleucel (MB-CART2019.1)

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

Sponsors & Collaborators

  • PPD, Part of Thermo Fisher Scientific

    collaborator INDUSTRY

  • Miltenyi Biomedicine GmbH

    lead INDUSTRY

Principal Investigators

  • Birgit Burkhardt, Prof. Dr. · Uniklinik Münster, Klinik für Kinder- und Jugendmedizin Pädiatrische Hämatologie/Onkologie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-08-04
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • France
  • Germany
  • Italy
  • Netherlands

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06508931 on ClinicalTrials.gov