NCT06209671

INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia

A Clinical Study to Evaluate the Safety and Efficacy of INS19 CAR-T Cells for the Treatment of Relapsed or Refractory Acute B Lymphoblastic Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Beijing Immunochina Medical Science & Technology Co., Ltd. · Industry
• Sex: All
• Age: 3 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety, tolerability, and pharmacokinetic profile of INS19 CAR-T cells for the treatment of patients with relapsed or refractory acute B lymphoblastic leukemia

Detailed description

The study is planned to enroll 9-12 patients with relapsed or refractory acute B-lymphoblastic leukemia in a modified "3+3" design with two dose groups of 1×10\^7 cells and 2×10\^7 cells (dose halved for subjects weighing \<40 kg). Each dose group is planned to enroll 3-6 subjects to assess safety, and ultimately the SRC will decide whether to continue to add escalating dose groups or to conduct an extension study in a specific dose group based on available safety and efficacy information, with 3-6 subjects to be enrolled in the extension phase. This study will be divided into a screening period, a cell collection period, a chemotherapy pretreatment period, a return infusion and a follow-up period, and within 28 days of return infusion the investigator will assess whether a DLT (Dose limited toxicity) event has occurred to confirm the safety of this dose group.

Conditions

• Leukemia, B-cell

Interventions

Type	Name	Description
BIOLOGICAL	INS19 CAR-T Cells	INS19 CAR-T Cells, 1-2×10\^7 cells, treatment follows a lymphodepletion. Drug: Fludarabine Recommendation: 25-30 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline. Drug: Cyclophosphamide Recommendation: 250-300 mg/m\^2/day (D-5\~D-3), determined by tumor burden at baseline.

Timeline

• Start date: 2024-01-15
• Primary completion: 2025-01-15
• Completion: 2026-01-15
• First posted: 2024-01-17
• Last updated: 2024-01-17