Universal CD19-specific CAR gene-engineered T cells
Universal CD19-specific CAR gene-engineered T cells: Infusion of 4SCAR19U cells
Study summary
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.
Eligibility
Sex
ALL
Min age
6 Months
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
1. Age older than 6 months.
2. Primary B cell surface expression of CD19.
3. The KPS score over 80 points, and survival time is more than 1 month.
4. Greater than Hgb 80 g/L.
5. No contraindications to blood cell collection.
Exclusion Criteria:
1. Accompanied with other active diseases, and difficult to assess response after treatment.
2. Bacterial, fungal, or viral infection, unable to control.
3. Living with HIV.
4. Active HBV or HCV infection.
5. Pregnant and nursing mothers.
6. under systemic steroid treatment within a week of the treatment.
7. Prior failed CAR-T treatment.
Primary outcome measure(s)
Safety of 4SCAR19U CAR-T cells infusion — 24 weeks Safety of 4SCAR19U T cells in patients with relapsed and refractory B-ALL, BCL using CTCAE 4 standard to evaluate the level of adverse events
Trial sites (1)
Facility
City
Region
Status
Shenzhen Geno-Immune Medical Institute
Shenzhen
Guangdong
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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