Status:
UNKNOWN
4SCAR-T Therapy Post CD19-targeted Immunotherapy
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Collaborating Sponsors:
ShiJiaZhuang Zhongxi Children Hospital
Shenzhen Children's Hospital
Conditions:
CD19 Negative B-cell Malignancies
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 (4SCAR-T) targeting CD19-negative B-ALL that express alternative surface...
Detailed Description
Anti-CD19 immunotherapy based on antibody conjugated drugs or CD19-CAR-T cells has demonstrated unprecedented positive response in relapsing/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL)....
Eligibility Criteria
Inclusion
- Age older than 6 months.
- B cell malignancies relapsed after anti-CD19 immunotherapy.
- Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20.
- 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.
- Bacterial, fungal, or viral infection 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.
- Judged difficult to cooporate for continued evaluation.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04430530
Start Date
June 1 2020
End Date
December 31 2023
Last Update
June 12 2020
Active Locations (3)
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1
Shenzhen Children's Hospital
Shenzhen, Guangdong, China, 518000
2
The Seventh Affilliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China, 518107
3
Shijiazhuang Zhongxi Children Hospital
Shijiazhuang, Hebei, China