Actively Recruiting
CD19/70 Bi-specific CAR-T Cells Targeting B Cell Malignancies
Led by Shenzhen Geno-Immune Medical Institute · Updated on 2022-06-29
30
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to assess the feasibility, safety, and effectiveness of a new bi-specific CAR-T cell therapy targeting CD19 and CD70 markers in patients with B cell cancers that have returned or not responded to previous treatments. The study focuses on patients with tumors expressing CD19 and/or CD70, exploring how these specially engineered T cells work and persist in the body. This is important because existing treatments targeting only CD19 often face challenges like tumor escape and reduced CD19 expression, which can lead to disease progression. Participants will receive an infusion of fourth-generation bi-4SCAR CD19/70 T cells at a dose of 10^6 cells per kilogram of body weight through an intravenous delivery. This bi-specific approach aims to improve treatment by targeting two tumor markers simultaneously to prevent relapse. The treatment includes booster and consolidation applications to enhance long-term effects. The study is conducted in phases 1 and 2 to evaluate both safety and anti-tumor activity over time. During the study, patients will be monitored closely with assessments of safety within the first 12 weeks and anti-tumor activity over one year. Researchers will evaluate how the bi-specific CAR-T cells perform and persist in the body, including laboratory tests and clinical evaluations. The total study duration allows for long-term follow-up to understand treatment effects and patient outcomes. Participants may undergo blood tests and clinical scoring to track their health status and response to therapy throughout the trial.
CONDITIONS
Brief Title
CD19/70 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 CD70 molecules
- Karnofsky Performance Status 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 making patient response difficult to assess
- Uncontrolled bacterial, fungal, or viral infections
- Living with HIV
- Active hepatitis B or C infection
- Pregnant or nursing mothers
- Systemic steroid treatment within one week before treatment
- Prior failed treatment with CD19 and CD70 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 - 12 weeks
Participants receive infusions of bi-4SCAR CD19/70 T cells targeting their B cell malignancies.
Approximately weekly visits for up to 12 weeks
Duration - Up to 1 year
Participants are monitored for anti-tumor activity and safety of the CAR-T cell therapy.
Periodic visits during the year following 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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