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BCMA-targeted LCAR-BCDR Cells in Patients With Relapsed/Refractory Multiple Myeloma

StatusCompleted
PhasePhase 1
Started
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Record History

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  1. Reclassified as completed (was terminated) Show 4 more changesShow less
    • Eligibility criteria expanded, about 19 words
    • Study description revised
    • Site details revised at 3 of 6 sites
    • Collaborators: details revised at 3 of 6 entries
  2. Lead sponsor: Weijun Fu to Shanghai Changzheng Hospital
    • Study description expanded, about 42 words
    • Study sites revised (6)
    • Collaborators: 1 to 6
    v9
  3. Trial status: Recruiting to Terminated Sponsor's reason: Per sponsor requestv8 Show 4 more changesShow less
    • Primary completion date changed from estimate of Jun 2024 to May 27, 2025
    • Enrollment target: estimated 32 to confirmed 24
    • Study completion date changed from estimate of Sep 2026 to May 27, 2025
    • Site details revised at 6 of 6 sites
  4. Study sites: 5 to 6v7
  5. Study sites: 4 to 5v6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 3 to 4v5
  2. Site details revised at 1 of 3 sitesv4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Aug 2022 to Sep 1, 2022
    • Site details revised at 3 of 3 sites
    v3
  4. Start date: May 2022 to Aug 2022
    • Study sites: 1 to 3
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is a prospective, single-arm, open-label, dose-finding and dose-expansion study that evaluates the safety, tolerability, PK, and anti-tumor efficacy of LCAR-BCDR cell preparations in relapsed/refractory multiple myeloma subjects who received adequate standard therapy.
Trial Details
NCT Number NCT05376345
Lead Sponsor Shanghai Changzheng Hospital
Collaborators: Nanjing Legend Biotech Co., First Affiliated Hospital of Wenzhou Medical University, Beijing Boren Hospital, Zhejiang Provincial People's Hospital, Shanghai Fourth People's Hospital Tongji University, Institute of Hematology & Blood Diseases Hospital, China
Conditions
(from sponsor)		 Relapsed/Refractory Multiple Myeloma
Related terms Multiple Myeloma
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov