Bi-specific CAR-T cell therapy for B cell malignancies
CD19/70 Bi-specific CAR-T Cells Targeting B Cell Malignancies
This study is testing a new type of CAR-T cell therapy that targets two proteins to see if it can help patients with tough-to-treat B cell cancers feel better and live longer.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 6 Months to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | CAR-T, CAR T, chimeric antigen receptor |
| Locations | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT05436496 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety, feasibility, and efficacy of a novel CD19/70 bi-specific CAR-T cell therapy in patients with CD19 and/or CD70 positive B cell malignancies. It aims to address the limitations of existing CD19-targeting therapies by utilizing genetically modified T cells that can recognize and eliminate tumor cells expressing either CD19 or CD70. The study will assess the persistence and function of these engineered T cells in patients with refractory or recurrent malignancies, which have poor prognoses despite current treatments.
Who should consider this trial
Good fit: Ideal candidates include patients over 6 months old with malignant B cell tumors expressing CD19 or CD70.
Not a fit: Patients with active infections, other serious diseases, or those who have previously failed CD19 and CD70 CAR-T treatments may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with difficult-to-treat B cell malignancies.
How similar studies have performed: While CAR-T therapies have shown success in treating B cell malignancies, the bi-specific approach targeting both CD19 and CD70 is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age older than 6 months. 2. malignant B cell surface expression of CD19 or CD70 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 CD70 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.