Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
100 participants
INTERVENTIONAL
2019-07-15
2023-12-15
Brief Summary
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Detailed Description
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Potential markers for recurrent leukemic blasts in an emerging CD19-negative blast population include many known B-cell lineage antigens. To prevent further target escape and improve the therapeutic effects, CAR gene-modified T cells targeting CD22, CD123, CD38, CD10, CD20 or TSLPR have been considered in post CD19 CAR-T immunotherapy. This study aims to evaluate safety and efficacy of administrating one or multiple non-CD19 targeting CAR-T cells to patients with CD19-negative B cell malignancies.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
Interventions
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4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR
4SCAR-CD22/CD123/CD38/CD10/CD20/TSLPR Patients who have relapsed after CD19 CART immunotherapy or have CD19 negative B cell malignancies
Eligibility Criteria
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Inclusion Criteria
2. Native CD19 negative B cell malignancies or relapse after CD19-CAR-T immunotherapy.
3. Malignant B cells expressing one or more of the following surface molecules: CD22/CD123/CD38/CD10/CD20/TSLPR.
4. The KPS score over 80 points, and survival time is more than 1 month.
5. Greater than Hgb 80 g/L.
6. No contraindications to blood cell collection.
Exclusion Criteria
2. Bacteria, fungus, or virus infection, and unable to control.
3. Living with HIV.
4. Active HBV and HCV infection.
5. Pregnant and nursing mothers.
6. Under systemic steroid use within a week of the treatment.
6 Months
75 Years
ALL
No
Sponsors
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Shenzhen Geno-Immune Medical Institute
OTHER
Responsible Party
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Principal Investigators
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Lung-Ji Chang, PhD
Role: PRINCIPAL_INVESTIGATOR
Shenzhen Geno-Immune Medical Institute
Locations
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Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China
Zhongxi Children Hospital
Shijiazhuang, Hebei, China
Countries
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Central Contacts
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Facility Contacts
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Yaochen Zhang, M.D
Role: primary
Other Identifiers
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GIMI-IRB-19003
Identifier Type: -
Identifier Source: org_study_id
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