4SCAR19U T Cells Targeting B Cell Malignancies

Recruiting now · Phase 1

Conditions studied: B Cell Malignancies

In brief

The purpose of this study is to assess the feasibility, safety and efficacy of universal CAR T cell therapy against CD19-positive hematological malignancies using a novel CD19-specific CAR T cell product, 4SCAR19U T cells. The study also aims to learn more about the function of the 4SCAR19U T cells and their persistence in patients. This is a phase I trial enrolling patients from multiple clinical centers.

Key facts

Study ID

NCT05995015

Run by

Shenzhen Geno-Immune Medical Institute

People needed

30

Starts

2026-06-01

Expected to finish

2030-12-31

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.
• Primary B cell surface expression of CD19.
• 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…

• Accompanied with other active diseases, and difficult to assess response after treatment.
• Bacterial, fungal, or viral infection, unable to control.
• Living with HIV.
• Active HBV or HCV infection.
• Pregnant and nursing mothers.
• under systemic steroid treatment within a week of the treatment.
• Prior failed CAR-T treatment.

Where it is running

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

Full record on ClinicalTrials.gov

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