Actively Recruiting
CD19/79b Bi-specific CAR-T Cells Targeting B Cell Malignancies
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2022-06-29
60
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This trial investigates a new bi-specific CAR-T cell therapy targeting CD19 and CD79b antigens in patients with B cell malignancies that are refractory or have recurred after previous treatments. The study aims to assess the safety, feasibility, and effectiveness of this fourth generation bi-4SCAR-CD19/79b CAR-T therapy, which is designed to address tumor relapse caused by loss of CD19 expression and improve long-term outcomes. The research also explores how well the infused CAR-T cells persist and function in patients. Participants receive an infusion of genetically modified bi-4SCAR-CD19/79b T cells at a dose of 10^6 cells per kilogram of body weight through an intravenous route. This therapy is intended to recognize and kill tumor cells expressing CD19 or CD79b, both common markers on B cell lymphoma cells. The study is conducted in phases one and two to evaluate safety and longer-term anti-tumor activity over one year. During the trial, patients are monitored closely for safety over a 12-week period and for anti-tumor effects for up to one year. Evaluations include assessments of symptoms, laboratory tests, and overall health to understand how the therapy affects disease progression. Participants must meet specific health criteria to enroll and will be followed until the study ends in June 2026 to collect comprehensive outcome data.
CONDITIONS
Brief Title
CD19/79b Bi-specific CAR-T Cell Therapy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age older than 6 months
- Malignant B cell tumor cells must express CD19 or CD79b molecules
- Karnofsky Performance Status (KPS) score over 80 points
- Expected survival time more than 1 month
- Hemoglobin level greater than 80 g/L
- No contraindications to blood cell collection
You will not qualify if you...
- Presence of other active diseases that make response assessment difficult
- Uncontrolled bacterial, fungal, or viral infection
- Living with HIV infection
- Active hepatitis B or C virus infection
- Pregnant or nursing mothers
- Systemic steroid treatment within one week before therapy
- Previous failed treatment with CD19 and CD79b CAR-T therapy
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 12 weeks
Participants receive infusions of bi-4SCAR-CD19/79b T cells targeting B cell malignancies.
Multiple visits for cell infusion and monitoring during treatment
Duration - Up to 1 year
Participants are monitored for safety and anti-tumor activity after treatment.
Regular follow-up visits for up to 1 year
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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