A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
Recruiting
Phase 1
Phase 2
Interventional Study
B-cell Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 6 Months and older
- Sex
- Any
- Trial phase
- Phase 1/2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 200 (estimated)
- Sponsor
- Shenzhen Geno-Immune Medical Institute · Other
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About This Trial
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.
Trial Locations
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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 othe…
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