NCT07043218

A Clinical Study Exploring Universal CAR-T Cell in Patients With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of Universal CAR-T Cell in Patients With CD19 and/or CD20 Positive Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia.

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Shanghai Tongji Hospital, Tongji University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

A Clinical Study to Investigate the Safety, Efficacy, and Cellular Metabolism of CT119X(including CT1190-P and CT1192) CAR-T Cell therapy, in Patients with Relapsed/Refractory B-cell acute lymphoblastic leukemia.

Detailed description

This is a single-arm, open-label, dose exploratory clinical study to evaluate the safety, efficacy, cellular pharmacokinetics, and pharmacodynamics of CT119X (including CT1190-P and CT1192)cells in patients with B-ALL. It is planned to enroll 6-36participants.

Conditions

• B-cell Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	Chimeric Antigen Receptor T Cells (CAR-T)	chimeric antigen receptor T cells

Timeline

• Start date: 2025-07-10
• Primary completion: 2026-06-30
• Completion: 2027-06-30
• First posted: 2025-06-29
• Last updated: 2025-06-29

Locations

1 site across 1 country: China