Bi-specific CAR-T cell therapy for B cell malignancies
CD19/79b Bi-specific CAR-T Cells Targeting B Cell Malignancies
This study is testing a new type of CAR-T cell therapy that targets two specific markers on B cell cancers to see if it can help patients whose cancer hasn't responded to other treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 6 Months to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor, immunotherapy |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05436509 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of a novel bi-specific CAR-T cell therapy targeting CD19 and CD79b in patients with refractory or recurrent B cell malignancies. The approach involves genetically modifying T cells to express a bi-specific CAR that can recognize and attack tumor cells expressing either CD19 or CD79b. The study aims to improve treatment outcomes for patients who have not responded to existing therapies, particularly those who have lost CD19 expression on their tumors. By assessing the persistence and function of these modified T cells, the research seeks to provide insights into a potentially curative strategy for these challenging cancers.
Who should consider this trial
Good fit: Ideal candidates include patients over 6 months old with malignant B cell tumors expressing CD19 or CD79b.
Not a fit: Patients with active infections, other serious diseases, or those who have previously failed CD19 or CD79b CAR-T treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment option for patients with difficult-to-treat B cell malignancies.
How similar studies have performed: While CAR-T therapies have shown promise, this bi-specific approach is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD79b molecules. 3. the KPS score over 80 points, and survival time is more than 1 month. 4. greater than Hgb 80 g/L. 5. no contraindications to blood cell collection. Exclusion Criteria: 1. accompanied with other active diseases and difficult to assess patient response. 2. bacterial, fungal, or viral infection, unable to control. 3. living with HIV. 4. active HBV or HCV infection. 5. pregnant and nursing mothers. 6. under systemic steroid treatment within a week of the treatment. 7. prior failed CD19 and CD79b CAR-T treatment.
Where this trial is running
Shenzhen, Guangdong
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Lung-Ji Chang, PhD
- Email: c@szgimi.org
- Phone: 86-0755-86725195
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.