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A Phase I Trial to Establish the Safety and Maximum Tolerated Dose of High-affinity Autologous BCMA-targeting Chimeric Antigen Receptor (CAR) T-cells in Patients With Relapsed and Refractory B-cell Malignancies

Study acronym: CARLOTTA01
StatusRecruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Re-verified, no change to tracked fieldsv8
  2. Primary completion date: Jun 2025 to Jun 2027
    • Study completion date: Jun 2026 to Jun 2027
    v7
  3. Re-verified, no change to tracked fieldsv6
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2024 to Feb 15, 2024
    • Site details revised
    v5
  5. Start date: Dec 2023 to Feb 2024v4
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  1. Start date: Jul 2023 to Dec 2023v3
  2. Primary endpoints: 3 to 5
    • Eligibility criteria expanded, about 52 words
    • Study title expanded, about 3 words
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
The purpose of this phase I study is to determine whether MDC-CAR-BCMA001 (BCMA directed CAR T-cells) is safe and tolerable in the treatment of relapsed and refractory B-cell malignancies
Trial Details
NCT Number NCT05836896
Lead Sponsor Technische Universität Dresden
Collaborators: German Cancer Research Center
Conditions
(from sponsor)		 Neoplasms, Relapsed Diffuse Large B-cell Lymphoma (DLBCL), Refractory Diffuse Large B-cell Lymphoma (DLBCL), Multiple Myeloma, Refractory, Multiple Myeloma in Relapse
Related terms Lymphoma, Large B-Cell, Diffuse, Multiple Myeloma, Neoplasms
Enrollment 16 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov