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

Leukemia, B-cell Clinical Trial

Official title: 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 Not yet recruiting

Clinical Trial 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

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Leukemia
• Leukemia, B-cell
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

• NCT number: NCT06209671
• Study type: Interventional
• Source: Beijing Immunochina Medical Science & Technology Co., Ltd.
• Contact: Xiangyu Zhao, PhD
• Phone: 8610 88326666
• Email: Zhao_xy@bjmu.edu.cn
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: January 15, 2024
• Completion date: January 15, 2026