NCT02546739

Immunotherapy With CD19 CAR T-cells for B-Cell Lymphoma, ALL and CLL

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

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Beijing Doing Biomedical Co., Ltd. · Industry
• Sex: All
• Age: 18 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+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. 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+ malignancies.

Conditions

• Leukemia
• Lymphoma

Interventions

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

Timeline

• Start date: 2021-03-01
• Primary completion: 2022-03-01
• Completion: 2023-03-01
• First posted: 2015-09-11
• Last updated: 2021-01-26

Locations

12 sites across 1 country: China