Status:
UNKNOWN
CAR-T Immunotherapy Targeting CD19- ALL
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
B-cell Leukemia
Eligibility:
All Genders
6-75 years
Phase:
PHASE1
PHASE2
Brief Summary
This study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 negative ALL that express CD22, CD123, CD38, CD10, CD20 a...
Detailed Description
Anti-CD19 chimeric antigen receptor T cell therapy has demonstrated unprecedented treatment responses in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL). However, many studies hav...
Eligibility Criteria
Inclusion
- Age older than 6 months.
- Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
- Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
- 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
- Complications with other active diseases, and difficult to assess patient response.
- Bacteria, fungus, or virus infection, and unable to control.
- Living with HIV.
- Active HBV and HCV infection.
- Pregnant and nursing mothers.
- Under systemic steroid use within a week of the treatment.
Key Trial Info
Start Date :
July 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 15 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04016129
Start Date
July 15 2019
End Date
December 15 2023
Last Update
September 19 2019
Active Locations (3)
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1
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510282
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Zhongxi Children Hospital
Shijiazhuang, Hebei, China, 050006