CAR-T cell therapy for autoimmune diseases
CAR-T Cells Targeting B Cell Related Autoimmune Diseases
This study is testing if a new type of CAR-T cell therapy can help people with autoimmune diseases like pemphigus vulgaris and lupus by targeting harmful cells while keeping their immune system safe.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shenzhen Geno-Immune Medical Institute Academic / other |
| Drugs / interventions | CAR-T, chimeric antigen receptor |
| Locations | 2 sites (Shenzhen, Guangdong and 1 other locations) |
| Trial ID | NCT05459870 on ClinicalTrials.gov |
What this trial studies
This study evaluates the feasibility, safety, and efficacy of CAR-T cell therapy in patients suffering from autoimmune diseases. It aims to understand how well CAR-T cells can target and eliminate autoreactive B lymphocytes while preserving protective immunity. The therapy utilizes genetically modified T cells expressing a 4th generation anti-CD19 CAR, which is designed to enhance safety and effectiveness. The study will include patients with conditions such as pemphigus vulgaris and systemic lupus erythematosus, focusing on the persistence and function of the CAR-T cells in these patients.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with autoimmune diseases expressing B cell surface molecules.
Not a fit: Patients with active infections, other serious diseases, or those who have previously failed CAR-T treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a novel treatment option for patients with autoimmune diseases by effectively targeting and eliminating harmful B cells.
How similar studies have performed: Other studies have shown promising results using CAR-T cell technology for treating autoimmune diseases, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. age older than 18 years. 2. expression of B cell surface molecules. 3. the KPS score over 80 points, and survival time is more than 3 months. 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 treatment 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 CAR-T treatment.
Where this trial is running
Shenzhen, Guangdong and 1 other locations
- Shenzhen Geno-immune Medical Institute — Shenzhen, Guangdong, China (Recruiting)
- Guilin Hospital of Chinese Traditional and Western Medicine — Guilin, Guangxi, 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.