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Base Edited CAR T Cells Against AML: Deep Conditioning Ahead of Allogeneic Stem Cell Transplantation

Study acronym: CARAML
StatusActive, Not Recruiting
PhasePhase 1
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 14, 2026 (before its estimated June 1, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Jun 30, 2025 to Jun 1, 2026
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Jun 30, 2026 to Jun 1, 2026
    • Site details revised
    v4
  2. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of Jul 15, 2023 to Jul 21, 2023
    v3
  3. Start date: Jul 1, 2023 to Jul 15, 2023
    • Study description expanded, about 1 word
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
In this phase 1 clinical trial, the investigators are testing an experimental medicine in children aged 6 months up to 16 years with acute myeloid leukaemia (AML), which has come back (relapsed). The new product is made from white blood cells (T cells) collected from a healthy donor and changed so they can kill leukaemia cells. These 'ready-made' CAR T cells have been made using a new technique called Base Editing to modify their DNA code and have been given the code name 'BE CAR-33'. This technique allows them to work after chemotherapy and also disarms them to prevent effects against normal cells. The main purpose of this study is to assess the safety of the 'BE CAR-33' therapy and to see if ready-made CAR T cells can get rid of Acute Myeloid Leukaemia ahead of a planned bone marrow transplant that will hopefully prevent the leukaemia from returning.
Trial Details
NCT Number NCT05942599
Lead Sponsor Great Ormond Street Hospital for Children NHS Foundation Trust
Collaborators: Wellcome Trust
Conditions
(from sponsor)		 Relapsed Acute Myeloid Leukaemia
Related terms Leukemia, Myeloid, Acute
Enrollment 10 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov