CAR-T Immunotherapy Targeting CD19- ALL
CART Immunotherapy Targeting CD19 Negative Acute Lymphoblastic Leukemia
1 other identifier
interventional
100
1 country
3
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 and TSLPR, as many patients developed CD19-negative disease after CD19 CART immunotherapy. 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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2025
Longer than P75 for phase_1
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2019
CompletedFirst Posted
Study publicly available on registry
July 11, 2019
CompletedStudy Start
First participant enrolled
July 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 15, 2029
April 23, 2026
April 1, 2026
3 years
July 4, 2019
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of infusion
Treatment-related adverse events are assessed by NCI CTCAE V4.0 criteria.
24 weeks
Secondary Outcomes (1)
Anti-tumor activity of CART
1 year
Study Arms (1)
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
EXPERIMENTALPatients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
Interventions
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282, China
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
Zhongxi Children Hospital
Shijiazhuang, Hebei, 050006, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Lung-Ji Chang, PhD
Shenzhen Geno-Immune Medical Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2019
First Posted
July 11, 2019
Study Start
July 15, 2025
Primary Completion (Estimated)
July 15, 2028
Study Completion (Estimated)
December 15, 2029
Last Updated
April 23, 2026
Record last verified: 2026-04