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NCT03050190
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
Conditions: B-cell Malignancies
Sex: All
Ages: 6 Months – N/A
Healthy volunteers: No
Phase: PHASE1, PHASE2
Enrollment: 200
Sponsor: Shenzhen Geno-Immune Medical Institute
Location: Shenzhen Geno-immune Medical Institute Shenzhen Guangdong
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. aged more than 6 months.
2. malignant B cell surface expression CD19 molecules.
3. the KPS score over 80 points, and survival time is more than 3 months.
4. greater Hgb 80 g/L.
5. no contraindications to solid and cell separation
Exclusion Criteria:
1. accompanied with other active diseases, the treatment is difficult to correct.
2. bacteria, fungus, or virus infection, unable to control.
3. people living with HIV.
4. active HBV and HCV infection.
5. of pregnancy and nursing mothers.
6. before entering the test of the use of glucocorticoid systemic treatment within a week.
7. confirmed before used CAR - but invalid
Source: ClinicalTrials.gov (NCT03050190). StuddyBuddy aggregates publicly available trial information.