NCT06777264

Inaticabtagene Autoleucel (Inati-cel; CNCT19) Treatment for Newly Diagnosed B-cell ALL Patients in CR1

Clinical Study on Inaticabtagene Autoleucel (Inati-cel; CNCT19) Injection for Adolescents and Adults With B-Cell Acute Lymphoblastic Leukemia in First Complete Remission (CR1)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: First Affiliated Hospital of Zhejiang University · Academic / Other
• Sex: All
• Age: 14 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This investigator-initiated, prospective, single-arm, open-label, single-center phase II study aims to evaluate the long-term survival benefit and safety of a commercial CD19 CAR-T product in newly diagnosed Philadelphia chromosome-positive or negative (Ph-positive or Ph-negative) B-cell ALL patients who achieve CR1 after induction chemotherapy. A total of 20 patients will be enrolled in the study. The primary endpoints include disease-free survival (DFS) and overall survival (OS) rates after a median follow-up of 2 years, minimal residual disease (MRD) negativity rate, and the proportion of patients undergoing subsequent hematopoietic stem cell transplantation (HSCT). The frequency and severity of adverse events (AEs) and serious adverse events (SAEs) occurring after infusion will also be recorded.

Conditions

• Acute Lymphoblastic Leukemia
• B Cell ALL

Interventions

Type	Name	Description
BIOLOGICAL	Biological: single dose of Inaticabtagene autoleucel	Inaticabtagene autoleucel will be transfusioned intravenously at the recommended dose of 0.5×10\^8 (ranging 0.2-0.6×10\^8) viable CAR-T cells.

Timeline

• Start date: 2025-01-15
• Primary completion: 2026-12-15
• Completion: 2027-01-15
• First posted: 2025-01-15
• Last updated: 2025-01-15