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.
This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of anti-CD5 CAR-NK therapy for the treatment of patients with relapsed/refractory T-Cell hematologic malignancies. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×10⁷ CAR-positive cells/kg, 3×10⁷ CAR-positive cells/kg, and 5×10⁷ CAR-positive cells/kg. Each 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. The investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
15
Each 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.
Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology
Wuhan, Hubei, China
RECRUITINGIncidence 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.
Time frame: 28 dyas
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).
Time frame: 1month, 2 months, 3 months
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.
Time frame: 2 years
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.
Time frame: 2 years
Progression-Free-Survival (PFS) after CAR-NK infusion
PFS is the time from CAR-NK cell infusion to disease progression or death from any cause, capturing both tumor control and survival outcomes
Time frame: 2 years
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
Time frame: 3months
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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
Time frame: 3months
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
Time frame: 3months