Status:
RECRUITING
4SCAR19U T Cells Targeting B Cell Malignancies
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
B Cell Malignancies
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
Brief 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 prod...
Detailed Description
Chimeric antigen receptor (CAR) T cell therapy has proven effective in treating B cell malignancies. However, the application itself is still limited by the high cost and long preparation time which o...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2026
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05995015
Start Date
October 31 2023
End Date
December 31 2026
Last Update
October 12 2023
Active Locations (1)
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1
Shenzhen Geno-Immune Medical Institute
Shenzhen, Guangdong, China, 518000