A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies

Recruiting now · Phase 1/Phase 2

Conditions studied: B-cell Malignancies

In brief

The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) for patients with B cell malignancies. 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

NCT03050190

Run by

Shenzhen Geno-Immune Medical Institute

People needed

200

Starts

2025-05-01

Expected to finish

2029-12-31

Last updated by the study team

2026-06-23

Who can join

Age: 1 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• aged more than 6 months.
• malignant B cell surface expression CD19 molecules.
• the KPS score over 80 points, and survival time is more than 3 months.
• greater Hgb 80 g/L.
• no contraindications to solid and cell separation

You may not qualify if…

• accompanied with other active diseases, the treatment is difficult to correct.
• bacteria, fungus, or virus infection, unable to control.
• people living with HIV.
• active HBV and HCV infection.
• of pregnancy and nursing mothers.
• before entering the test of the use of glucocorticoid systemic treatment within a week.
• confirmed before used CAR - but invalid

Where it is running

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

Full record on ClinicalTrials.gov

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