This is a phase I, open-label, dose-escalation clinical trial. The primary objectives are to assess the safety of PA3-17 injection in pediatric and adolescent participants with relapsed/refractory T-lymphoblastic leukemia/lymphoma, and determine the recommended phase II dose of PA3-17 injection for this patient population.
Secondary objectives include evaluating the pharmacokinetics/pharmacodynamics, preliminarily assessing clinical efficacy, and evaluating the immunogenicity of the injection.
(1) Aged from 3 to 18 years (inclusive), with no restriction on gender. (2) Expected survival time ≥ 3 months. (3) At screening, Karnofsky Performance Status score (for subjects aged ≥ 16 years) or Lansky Performance Score (for subjects aged < 16 years) > 60 points (see Appendix 4).
Failure to achieve remission after treatment with two or more lines of chemotherapy regimens*.
Two or more episodes of relapse.
Relapse after hematopoietic stem cell transplantation. * Remission criteria: CR and CRi for T-ALL; CR and PR for T-LBL. (6) At screening: ① Abnormal tumor cells are detected in bone marrow and/or peripheral blood by multi-color flow cytometry, regardless of the presence or absence of extramedullary lesions on imaging. Abnormal tumor cells in bone marrow must be CD7-positive; abnormal tumor cells in peripheral blood must be CD7-positive, CD4-negative and CD8-negative.
(1) Patients judged by the investigator to require long-term use of immunosuppressants at screening.