A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
1 other identifier
interventional
200
1 country
2
Brief Summary
The study will evaluate safety and efficacy of a 4th generation chimeric antigen receptor gene-modified T cells targeting CD19 (4SCAR19) 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 May 2025
Longer than P75 for phase_1
2 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
February 8, 2017
CompletedFirst Posted
Study publicly available on registry
February 10, 2017
CompletedStudy Start
First participant enrolled
May 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2029
September 8, 2025
September 1, 2025
3.3 years
February 8, 2017
September 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of fourth generation anti CD19 CAR-T cells in patients with relapsed B cell malignancies using CTCAE 4 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 CAR-T cells in patients with relapsed or refractory B cell malignancies
1 year
Study Arms (1)
Therapeutic 4SCAR19 cells
EXPERIMENTALPatients who have relapsed and refractory B cell leukemia after chemotherapy will be treated prophylactically with CD19-specific gene-engineered T cells.
Interventions
Autologous 4th generation withdrawal lentiviral-transduced 4S CAR-T19
Eligibility Criteria
You may qualify if:
- aged more than 6 months.
- malignant B cell surface expression CD19 molecules.
- the KPS score over 80 points, and survival time is more than 3 months.
- greater Hgb 80 g/L.
- no contraindications to solid and cell separation
You may not qualify if:
- accompanied with other active diseases, the treatment is difficult to correct.
- bacteria, fungus, or virus infection, unable to control.
- people living with HIV.
- active HBV and HCV infection.
- of pregnancy and nursing mothers.
- before entering the test of the use of glucocorticoid systemic treatment within a week.
- confirmed before used CAR - but invalid
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
The First People's Hospital of Yunnan
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
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
February 8, 2017
First Posted
February 10, 2017
Study Start
May 1, 2025
Primary Completion (Estimated)
September 1, 2028
Study Completion (Estimated)
December 31, 2029
Last Updated
September 8, 2025
Record last verified: 2025-09