Actively Recruiting
CD19/22 Bi-specific CAR-T Cells Targeting B Cell Malignancies
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2022-06-27
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the feasibility, safety, and effectiveness of a new anti-CD19/22 bi-specific CAR-T cell therapy for patients with B cell malignancies that express CD19 and/or CD22. The study focuses on patients with refractory or recurrent B cell cancers who have poor outcomes despite existing treatments. It also seeks to understand how well these specially modified CAR-T cells persist and function in the body over time. Participants will receive an infusion of bi-4SCAR CD19/22 T cells, which are genetically engineered to target and kill cancer cells expressing CD19 or CD22. This therapy uses a 4th generation lentiviral vector to create bi-specific CAR-T cells designed to overcome tumor escape by recognizing two target molecules. The treatment is given by intravenous infusion at a dose of 10^6 cells per kilogram of body weight. The study includes booster and consolidation doses to enhance long-term effects. During the study, participants will be closely monitored for safety over 24 weeks and for anti-tumor activity over one year. Evaluations will include health assessments, laboratory tests, and tracking of the CAR-T cells’ persistence and function. The study is expected to last until June 2026 and involves adults and children older than six months who meet specific health criteria. Safety and therapeutic effects will be carefully measured to understand the potential benefits and risks of this novel CAR-T therapy.
CONDITIONS
Brief Title
CD19/22 Bi-specific CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 6 months
- Malignant B cell surface expression of CD19 or CD22 molecules
- Karnofsky Performance Status (KPS) score over 80 points
- Expected survival time more than 1 month
- Hemoglobin (Hgb) level greater than 80 g/L
- No contraindications to blood cell collection
You will not qualify if you...
- Presence of other active diseases making patient response difficult to assess
- Uncontrolled bacterial, fungal, or viral infection
- Living with HIV
- Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection
- Pregnant or nursing mothers
- Systemic steroid treatment within one week of treatment
- Prior failed CD19 and CD22 CAR-T treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 24 weeks
Participants receive infusions of bi-4SCAR CD19/22 T cells targeting their B cell malignancies to evaluate safety and anti-tumor activity.
Multiple visits for infusions and monitoring during treatment period
Duration - Up to 1 year
Participants are monitored for long-term safety and efficacy outcomes after treatment completion.
Periodic visits for up to 1 year post-treatment
Trial Site Locations
Total: 1 location
1
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
Actively Recruiting
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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