This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD5 CAR-NK in the treatment of patients with relapsed/refractory T-Cell hematologic malignancies.
Refractory to ≥2 cycles of standard induction chemotherapy (failure to achieve CR).
Relapsed within 12 months after achieving CR with first-line induction therapy.
Failure to achieve CR or relapse after ≥2 lines of chemotherapy.
Relapse after hematopoietic stem cell transplantation (HSCT).
Prior CAR-NK therapy or genetically modified cell therapy.
Active CNS involvement at screening (prior CNS involvement with resolved status post-treatment is allowed).
Chemotherapy, targeted therapy, or investigational drugs within 2 weeks or 5 half-lives prior to screening.
Radiotherapy within 2 weeks prior to screening.
Single group
Anti-CD5 CAR NK cells
Biological/VaccineEach patient will initially receive a single infusion of CAR-NK cells on Day 0. If a suboptimal response is observed after the first infusion (assessed by Day 28) and the safety profile remains acceptable, a second infusion may be administered as a remedial dose after Day 28. CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.
Objective response rate (ORR)
Objective Response Rate (ORR) within 3 Months: 1. For patients with T-cell lymphoma, ORR includes complete response (CR) and partial response (PR); 2. For patients with T-cell acute lymphoblastic leukemia (T-ALL), ORR includes CR, CR with partial hematologic recovery (CRh), CR with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS).
Overall survival (OS) after CAR-NK infusion
OS is defined as the time from CAR-NK cell infusion to death from any cause, reflecting the long-term survival benefit of the therapy.
Duration of response (DOR) after CAR-NK infusion
DOR measures the time from the first achievement of objective response to disease progression or death, evaluating the durability of treatment efficacy in responding patients.
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Cmax:The highest concentration of CAR T cells amplified in peripheral blood after reinfusion
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacokinetics】
Tmax:The time to reach the highest concentration of CAR-NK cells in peripheral blood after reinfusion
To obtain the cytodynamics data of CAR-NK cells in vivo【pharmacodynamics】
The content of free IL-6 in peripheral blood at each time point after transfusion was determined by immunohistochemical method
Click on the lead sponsor to view all of their trials.
