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CAR-T Immunotherapy Targeting CD19- ALL

StatusNot Yet Recruiting
PhasePhase 1/2
Started
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Record History

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  1. Start date: Jul 15, 2025 to Jul 1, 2027v5 Show 5 more changesShow less
    • Trial status changed: Recruiting → Not Yet Recruiting
    • Study completion moved earlier from Dec 15, 2029 to Jun 30, 2029
    • Primary completion date: Jul 15, 2028 to Jun 30, 2028
    • Study description expanded, about 66 words
    • Site details revised
  2. Study sites: 3 to 1v4
  3. Primary completion date: Jul 15, 2021 to Jul 15, 2028
    • Start date: Jul 15, 2019 to Jul 15, 2025
    • Study completion date: Dec 15, 2023 to Dec 15, 2029
    v3
  4. Re-verified, no change to tracked fieldsv2
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.
Trial Details
NCT Number NCT04016129
Lead Sponsor Shenzhen Geno-Immune Medical Institute
Conditions
(from sponsor)		 B-cell Leukemia
Related terms Leukemia, B-Cell
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov