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CD19-directed CAR-T Cell Therapy for R/R Acute Leukemia and Lymphoma

Study acronym: CARTHEDRALL
StatusRecruiting
PhasePhase 1/2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Trial status: Not Yet Recruiting to Recruiting Start date changed from estimate of Oct 2023 to Mar 21, 2024 · Study sites: 1 to 5 · Primary and study completion dates: Oct 2028 to Dec 2028v2 Show 3 more changesShow less
    • Start date changed from estimate of Oct 2023 to Mar 21, 2024
    • Study sites: 1 to 5
    • Primary and study completion dates: Oct 2028 to Dec 2028
  2. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 goal of this prospective, multicentric, single-arm, phase I/II clinical trial is to evaluate the safety and efficacy of a novel CD19-directed CAR-T cell locally produced in an academic institution in Brazil in patients with refractory or relapsed acute lymphoblastic leukemia or non-Hodgkin lymphoma. Participants will receive a single intravenous infusion of an autologous academic anti-CD19 CAR-T cell and will be followed for 5 years.
Trial Details
NCT Number NCT06101381
Lead Sponsor University of Sao Paulo
Collaborators: Blood Center of Ribeirao Preto, Hospital das Clínicas de Ribeirão Preto
Conditions Leukemia, Acute Lymphoblastic, Lymphoma, Non-Hodgkin
Enrollment 81 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov