NCT04100187

Immunotherapy With CD19 CAR T-cells for B-Cell Leukemia

Phase I Study of T Cells Expressing an Anti-CD19 Chimeric Receptor in Children and Young Adults With B Cell Leukemia

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Kecellitics Biotech Company Ltd · Industry
• Sex: All
• Age: 2 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.

Detailed description

This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ Leukemia. Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR Tcells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ Leukemia

Conditions

• Leukemia

Interventions

Type	Name	Description
BIOLOGICAL	Anti-CD19-CAR	Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.)

Timeline

• Start date: 2023-02-01
• Primary completion: 2023-08-01
• Completion: 2024-08-01
• First posted: 2019-09-24
• Last updated: 2022-12-01