NCT07361029

CD19 Chimeric Antigen Receptor (CAR) T Cells in Adults With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia

Phase Ia Study of a LentiGen® CD19 Chimeric Antigen Receptor (CAR) T Cells in Adult Patients With Relapsed/Refractory CD19 Positive Acute Lymphoblastic Leukemia (ALL) Using a Closed Transduction System

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: King Faisal Specialist Hospital & Research Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase Ia, open label, dose finding single center trial designed to evaluate the maximum tolerated dose, safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of CD19 CAR T cells targeting the B cell surface antigen CD19 following administration of chemotherapy lymphodepletion regimen in adults (age 18 - 75) with relapsed/refractory acute lymphoblastic leukemia (ALL).

Detailed description

Approximately 24 patients are planned to be enrolled in four cohorts during the dose-escalation stage. Within each cohort, 3 patients will receive treatment with CD19 CAR T cells. The starting dose level is 5x10\*5cells/kg, administered as a single dose by IV infusion. Dose escalation will proceed in accordance with the dose-escalation Dose-escalation decisions will be made by the Data Safety Monitoring Board (DSMB) in consultation with the investigators . CD19 CAR T cells administration between the first and second patient in each dose level will be separated by a minimum of 4 weeks. CD19 CAR T cells administration between each subsequent patient in a dose level will be separated by a minimum of 2 weeks.

Conditions

• Relapsed Refractory Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
OTHER	CAR T cells chimeric antigen receptor cells	CAR T Cells

Timeline

• Start date: 2025-07-29
• Primary completion: 2027-07-01
• Completion: 2028-07-01
• First posted: 2026-01-22
• Last updated: 2026-01-22

Locations

1 site across 1 country: Saudi Arabia