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A Study to Evaluate Efficacy and Safety of Ciltacabtagene Autoleucel

Study acronym: CARTITUDE-10
StatusRecruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Lead sponsor: Janssen Research & Development, LLC to Janssen Research & Development, LLC Trial sites expanded: 17 → 20 locations · Eligibility criteria expanded, about 9 words · Secondary endpoints: details revised at 3 of 9 entries Show 3 more changesShow less
    • Trial sites expanded: 17 → 20 locations
    • Eligibility criteria expanded, about 9 words
    • Secondary endpoints: details revised at 3 of 9 entries
  2. 3 versions Re-verified since Jun 4, 2026, no change to tracked fieldsv11-v13
  3. Study sites: 16 to 17v10
  4. Study sites: 15 to 16v9
  5. Study sites: 14 to 15 Primary completion date: Jan 3, 2028 to Apr 12, 2028v8 Show 1 more changeShow less
    • Primary completion date: Jan 3, 2028 to Apr 12, 2028
Show 6 earlier versionsHide 6 earlier versions
  1. Study sites: 11 to 14 Completion date: Dec 29, 2028 to Apr 6, 2029v7 Show 1 more changeShow less
    • Completion date: Dec 29, 2028 to Apr 6, 2029
  2. Study sites: 9 to 11v6
  3. Study sites: 8 to 9v5
  4. Study sites: 6 to 8v4
  5. Study sites: 4 to 6 Start date changed from estimate of Sep 8, 2025 to Oct 3, 2025v3 Show 1 more changeShow less
    • Start date changed from estimate of Sep 8, 2025 to Oct 3, 2025
  6. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 4 · Interventions: Cilta-cel (Drug), Cyclophosphamide (Drug), Induction therapy (Drug) to Cilta-cel (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Induction therapy (Drug) · Eligibility criteria expanded, about 12 words · 2 morev2 Show 5 more changesShow less
    • Study sites: 0 to 4
    • Interventions: Cilta-cel (Drug), Cyclophosphamide (Drug), Induction therapy (Drug) to Cilta-cel (Drug), Cyclophosphamide (Drug), Fludarabine (Drug), Induction therapy (Drug)
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 9 of 9 entries
    • Study arms: 1 to 2

    See this version in full on ClinicalTrials.gov ↗

  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is to evaluate how well (efficacy) cilta-cel works when given with a fludarabine-free lymphodepletion regimen (a process of reducing the number of lymphocytes, a type of white blood cell in the body, typically through chemotherapy), or an alternative administration of cilta-cel infusion following a cyclophosphamide and fludarabine lymphodepletion regimen.
Trial Details
NCT Number NCT07149857
Lead Sponsor Janssen Research & Development, LLC
Conditions Multiple Myeloma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov