To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.
This study is a Phase II, single-arm, open-label, single-infusion clinical trial designed to evaluate the clinical efficacy and safety of S101 in patients with CD7-positive relapsed or refractory T-lymphoblastic lymphoma/leukemia (T-LBL/ALL). The primary objective: To evaluate the efficacy of S101 in patients with relapsed or refractory T-LBL/ALL. The secondary objectives: To further characterize the efficacy, safety, pharmacokinetics and pharmacodynamics of S101 in this patient population.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
38
Autologous CD7-targeting CAR T cells, dosage 2\*10\^6/kg, intravenous injection once
Objective response rate after S101 infusion [Effectiveness]
Independent Review Committee (IRC)-assessed ORR at Month 3 post-infusion.
Time frame: 3 months
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