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Not yet taking people in ChinaPhase 1/2

Modified immune cells tested in leukemia that stopped responding to CD19 therapy

Tests modified T cells in people with CD19-negative acute lymphoblastic leukemia.

Plain-language title generated from the registry record
Registry title: CAR-T Immunotherapy Targeting CD19- ALL

Key facts

Where
Shenzhen, ChinaSee the site
Phase
Phase 1/2

Where in China

  • Shenzhen Geno-immune Medical InstituteShenzhen, ChinaNo longer taking part

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Trial details

Who runs it
Shenzhen Geno-Immune Medical Institute
Trial code
NCT04016129
Record updated
2 November 2026
Original description
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.Read full original descriptionShow less

CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia

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.

Inclusion: Age older than 6 months; Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy; Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR; The KPS score over 80 points, and survival time is more than 1 month; Greater than Hgb 80 g/L; No contraindications to blood cell collection.

Exclusion: Under systemic steroid use within a week of the treatment; Complications with other active diseases, and difficult to assess patient response; Bacteria, fungus, or virus infection, and unable to control; Living with HIV; Active HBV and HCV infection; Pregnant and nursing mothers.

ClinicalTrials.gov NCT04016129