Functional Improvement of Chimeric Antigen Receptor Through Intrinsic Interleukin-15Rα Signaling.
Sushmita Nair, Jing-Bo Wang, Shih-Ting Tsao...
https://pubmed.ncbi.nlm.nih.gov/30444200Actively Recruiting
Phase 1
Phase 2
Age: 6Months +
All Genders
ID03050190
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2025-09-08
200
Participants Needed
2
Research Sites
69 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of a new type of gene-modified T cell therapy called 4SCAR19 for patients with B cell malignancies that have returned or not responded to standard treatments. This phase I/II trial involves multiple clinical centers and aims to study both clinical responses and the development of a standardized process to produce these modified cells. The therapy uses a fourth-generation chimeric antigen receptor (CAR) that targets CD19 on cancer cells and includes safety features to control immune responses. The treatment process involves collecting a patient’s blood cells through apheresis, activating and modifying their T cells with the 4SCAR19 gene using a lentiviral vector, and then infusing these engineered cells back into the patient. Before infusion, patients receive a chemotherapy-based conditioning regimen with cyclophosphamide and fludarabine to prepare their immune system. The cell preparation takes approximately 5 to 7 days, and the modified cells are infused following the conditioning treatment. Participants will be closely monitored for safety and treatment responses, including tracking the presence of CAR T cells in their blood over time. Safety is assessed using standard criteria for adverse events over 24 weeks, while tumor response is followed for up to one year. Throughout the study, patients undergo clinical evaluations and laboratory tests to measure outcomes and monitor for any side effects. The trial is expected to continue until the end of 2029.
CONDITIONS
Brief Title
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
Who Can Participate
Age: 6Months +
All Genders
Eligibility Criteria
You may qualify if you...
- Aged more than 6 months
- Malignant B cell cancer with CD19 molecule expression
- Karnofsky Performance Status (KPS) score over 80 points
- Expected survival time more than 3 months
- Hemoglobin level greater than 80 g/L
- No contraindications to solid and cell separation procedures
You will not qualify if you...
- Presence of other active diseases that are difficult to treat
- Uncontrolled bacterial, fungal, or viral infections
- Living with HIV
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Pregnant or nursing mothers
- Use of systemic glucocorticoid treatment within one week before trial entry
- Previous use of CAR therapy without success
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Run-in Period
Duration - 5 to 7 days
Participants undergo collection and activation of their T cells, which are then genetically modified to express the 4SCAR19 gene.
1 apheresis visit and cell preparation
Treatment
Duration - Day of infusion plus preparative days
Participants receive a preparative chemotherapy regimen followed by infusion of the modified 4SCAR19 T cells.
1 to 3 visits including chemotherapy preparation and cell infusion
Follow-up
Duration - Up to 24 weeks or longer
Participants are closely monitored for treatment-related responses and safety over time.
Multiple visits for monitoring and clinical assessments
Trial Site Locations
Total: 2 locations
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
2
The First People's Hospital of Yunnan
Kunming, Yunnan, China, 650000
Actively Recruiting
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Research Team
L
Lung-Ji Chang, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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