Combination CAR-T Cell Therapy Targeting Hematological Malignancies
Combination CAR-T Therapy of 4SCAR19 Plus 4SCAR20, 22, 38, 70 and 123 Targeting Hematological Malignancies
1 other identifier
interventional
100
1 country
4
Brief Summary
The study will evaluate safety and efficacy of a combination of 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) and CD20 (4SCAR20), CD22 (4SCAR22), CD30 (4SCAR30), CD38 (4SCAR38), CD70 (4SCAR70) or CD123 (4SCAR123) for patients with B cell malignancies. 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 Aug 2025
Longer than P75 for phase_1
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 19, 2017
CompletedFirst Posted
Study publicly available on registry
April 24, 2017
CompletedStudy Start
First participant enrolled
August 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
September 8, 2025
September 1, 2025
3.4 years
April 19, 2017
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 standard to evaluate the level of adverse events standard to evaluate the level of adverse events
physiological parameter (for safety, measuring cytokine response, fever, symptoms)
24 weeks
Secondary Outcomes (1)
Anti tumor activity of fourth generation anti CD19 and CD20/CD22/CD30/CD38/CD70/CD123 CAR-T cells in patients with relapsed or refractory B cell malignancies
1 year
Study Arms (1)
4SCAR19 and 4SCAR20/CD22/CD30/CD38/CD70/CD123
EXPERIMENTALPatients who have relapsed and refractory B cell malignancies after chemotherapy will be treated with CD19 and CD20/CD22/CD30/CD38/CD70/CD123-specific gene-engineered T cells.
Interventions
Eligibility Criteria
You may qualify if:
- age older than 6 months.
- malignant B cell surface expression of CD19/CD20/CD22/CD30/CD38/CD70/CD123 molecules.
- 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:
- accompanied with other active diseases, the treatment is difficult to assess patient response.
- bacteria, fungus, or virus infection, unable to control.
- living with HIV.
- active HBV and HCV infection.
- pregnant and nursing mothers.
- under systemic steroid treatment within a week of the treatment.
- prior failed CAR-T treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510282, China
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, 650000, China
Related Publications (1)
Nair S, Wang JB, Tsao ST, Liu Y, Zhu W, Slayton WB, Moreb JS, Dong L, Chang LJ. Functional Improvement of Chimeric Antigen Receptor Through Intrinsic Interleukin-15Ralpha Signaling. Curr Gene Ther. 2019;19(1):40-53. doi: 10.2174/1566523218666181116093857.
PMID: 30444200DERIVED
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
- PRINCIPAL INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
April 19, 2017
First Posted
April 24, 2017
Study Start
August 1, 2025
Primary Completion (Estimated)
December 31, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
September 8, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share