NCT07244380

Phase II Trial of S101 Autologous Anti-CD7 CAR-T Cells in Patients With R/R T-LBL/ALL.

A Phase II Clinical Trial of S101 Autologous CAR-T Cell Injection for the Treatment of CD7-Positive Relapsed or Refractory T-Lymphoblastic Lymphoma/Leukemia (T-LBL/ALL).

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 38 (estimated)
• Sponsor: Hebei Senlang Biotechnology Inc., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

To Evaluate the Efficacy and safety of S101 for Treating CD7-Positive Relapsed or Refractory T-LBL/ALL.

Detailed description

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.

Conditions

• T Lymphoblastic Leukemia/Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	Autologous CD7-targeting CAR T cells	Autologous CD7-targeting CAR T cells, dosage 2\*10\^6/kg, intravenous injection once

Timeline

• Start date: 2025-11-28
• Primary completion: 2026-09-30
• Completion: 2028-06-30
• First posted: 2025-11-24
• Last updated: 2025-11-24