U69-CART-Cells For R/R T-ALL

Overall Introduction This single-arm, open-label clinical trial aims to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of CXCR4-enabled CCR9 chimeric antigen receptor T-cell injection (CXCR4 CCR9 CAR-T) in patients with relapsed or refractory T-lymphoblastic leukemia/lymphoma (r/r T-ALL/LBL). Additionally, the study seeks to preliminarily assess the efficacy of CXCR4 CCR9 CAR-T cells and explore the appropriate dosage and administration schedule for subsequent Phase II clinical trials. A dose escalation study following the 3+3 design was implemented across three dose

Trial Details

NCT ID
NCT07350863
Phase
PHASE1
Sponsor
The First Affiliated Hospital of Soochow University
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • CXCR4 CCR9 CAR-T
Locations (sample)
  • Suzhou, Jiangsu, China|31.30408,120.59538

Key Eligibility Criteria

  • Subjects must meet all of the following criteria to be eligible for the study:
  • Informed Consent: Voluntary provision of written informed consent and anticipated ability to complete all required study procedures and follow-up a…
  • Age: ≥15 and ≤75 years of age at the time of signing the informed consent form.For minors (age ≤ 18 years), informed consent must be provided by a …
  • Diagnosis and Disease Status: Histologically or cytologically confirmed diagnosis of relapsed or refractory T-cell acute lymphoblastic leukemia/lym…

For full eligibility, visit ClinicalTrials.gov.

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