CAR-T Immunotherapy Targeting CD19- ALL

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Leukemia

In brief

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.

Key facts

Study ID

NCT04016129

Run by

Shenzhen Geno-Immune Medical Institute

People needed

100

Starts

2025-07-15

Expected to finish

2029-12-15

Last updated by the study team

2026-06-23

Who can join

Age: 1 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.
• Under systemic steroid use within a week of the treatment.

Where it is running

• Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (enrolling)

Full record on ClinicalTrials.gov

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