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

Study acronym: DALY PED
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study sites: 1 to 5v5
  2. Study title shortened, about 2 wordsv4 See this version in full on ClinicalTrials.gov ↗
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Jul 1, 2025 to Aug 4, 2025v3 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 1, 2025 to Aug 4, 2025
  4. Start date: Apr 1, 2025 to Jul 1, 2025 Primary completion date: Sep 29, 2029 to Dec 31, 2029 · Completion date: Oct 1, 2029 to Dec 31, 2029 · Eligibility criteria revised · 1 morev2 Show 4 more changesShow less
    • Primary completion date: Sep 29, 2029 to Dec 31, 2029
    • Completion date: Oct 1, 2029 to Dec 31, 2029
    • Eligibility criteria revised
    • Collaborators expanded, about 6 words

    See this version in full on ClinicalTrials.gov ↗

  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
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
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov