NCT04163575

Immunotherapy With CD22 CAR T-cells for B-Cell Lymphoma, ALL and CLL

Phase I Study of T Cells Expressing an Anti-CD22 Chimeric Receptor in Children and Young Adults With B Cell Malignancies

• Status: Unknown
• Phase: Phase 1 / Phase 2
• 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 CD22 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD22+ 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 CD22 Chimeric Antigen Receptor (CAR) T-cells (CD22 CAR T-cells) in patients with high risk, relapsed CD22+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD22 CAR Tcells. Patients will receive the CD22CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD22 CAR T-cells in patients with high risk relapsed CD22+ malignancies

Conditions

• Leukemia
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	:Anti-CD22-CAR	Cells extracted, followed by induction chemotherapy before CD22-CAR infusion (dose escalation.)

Timeline

• Start date: 2020-02-01
• Primary completion: 2021-07-01
• Completion: 2022-07-01
• First posted: 2019-11-14
• Last updated: 2019-12-23