Actively Recruiting
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
243 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Phase I/II Multiple Center Trial of 4SCAR19 Cells in the Treatment of Relapsed and Refractory B Cell Malignancies
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged more than 6 months.
- Malignant B cell surface expression of CD19 molecules.
- Karnofsky Performance Score (KPS) over 80 points and 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.
- Pregnancy or nursing mothers.
- Use of systemic glucocorticoid treatment within one week before entering the study.
- Previous use of CAR therapy that was ineffective.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
Research Team
L
Lung-Ji Chang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here