NCT06231368

CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure ≥3 Lines of Therapy.

The Safety and Efficacy of CNCT19 for Patients With Autoimmune Hemolytic Anemia After Failure of Three or More Lines of Therapy

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: Institute of Hematology & Blood Diseases Hospital, China · Academic / Other
• Sex: All
• Age: 12 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 1, single-arm, open-label, dose-escalation and dose-expansion study. The main purpose is to evaluate the safety and tolerability, efficacy of CNCT19 CAR T-cell therapy in patients with autoimmune hemolytic anemia after failure of three or more lines of therapy. Participants will receive CNCT19 cell infusion after preconditioning, and they will receive a 1-year follow-up.

Conditions

• Autoimmune Hemolytic Anemia
• Autologous CD19 CAR-T
• Failure of Three or More Lines of Therapy

Interventions

Type	Name	Description
BIOLOGICAL	CNCT19 CAR-T cell therapy	CNCT19 was a second-generation CAR T-cell with scFv derived from clone HI19α and 4-1BB/CD3-ζ costimulatory domain.

Timeline

• Start date: 2024-02-04
• Primary completion: 2024-11-18
• Completion: 2025-08-31
• First posted: 2024-01-30
• Last updated: 2025-05-16

Locations

1 site across 1 country: China