NCT04684147

Clinical Trial of CNCT19 Cell Injection in the Treatment of Relapsed or Refractory Acute Lymphoblastic Leukemia

Phase Ⅱ Clinical Trial of CNCT19 Cell Injection in the Treatment of CD19 Positive Relapsed or Refractory Acute Lymphoblastic Leukemia

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Juventas Cell Therapy Ltd. · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia.

Detailed description

The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of CD19 positive Relapsed or Refractory acute lymphoblastic leukemia. The study consists of screening period (8 weeks), treatment period (4 weeks), and follow-up period (2 years at most).

Conditions

• Relapsed or Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	single dose of CNCT19	Dose: 0.5 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide

Timeline

• Start date: 2020-12-24
• Primary completion: 2022-09-22
• Completion: 2026-12-31
• First posted: 2020-12-24
• Last updated: 2025-08-08

Locations

11 sites across 1 country: China