CAR-T Immunotherapy Targeting CD19- ALL

Status Recruiting

Clinical Trial Summary

This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. Clinical response and development of a standardized lentiviral vector and cell production protocol will be investigated. This is a phase I/II trial enrolling patients from multiple clinical centers.

Clinical Trial Description

Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies have reported that a subset of patients still relapse and about 30-50% of those relapses are characterized by the loss of CD19 surface antigen. Patients with CD19-negative relapse after CD19 CAR-T-cell therapy usually have a poor prognosis. The mechanisms underlying CD19-negative relapses are not fully understood and it is important to develop solutions to supplement post-CD19 immunotherapies.

Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies. ;

Study Design

Related Conditions & MeSH terms

B-cell Leukemia
Leukemia
Leukemia, B-Cell
Leukemia, Lymphocytic, Chronic, B-Cell

Clinical Trial Details

NCT number	NCT04016129
Study type	Interventional
Source	Shenzhen Geno-Immune Medical Institute
Contact	Lung-Ji Chang, PhD
Phone	+86-0755 8672-5195
Email	c@szgimi.org
Status	Recruiting
Phase	Phase 1/Phase 2
Start date	July 15, 2019
Completion date	December 15, 2023

View Details

See also
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