Treatment of autoimmune diseases using stem cells and CAR-T cells
Management of Autoimmune Conditions With Mesenchymal Stem Cells (MSCs) and CAR-T Cells
This study is testing a new treatment that combines stem cells and special immune cells to see if it can help people with autoimmune diseases 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 | 1 site (Shenzhen, Guangdong) |
| Trial ID | NCT06435897 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the safety, feasibility, and effectiveness of combining mesenchymal stem cells (MSCs) with CAR-T cells for treating autoimmune diseases. It focuses on understanding how this combination can target and eliminate harmful autoimmune cells while preserving protective immunity. The study will assess the long-term effects of this treatment approach on patients with established autoimmune conditions. Participants will undergo treatment with fetal MSCs and CAR-T cells specifically designed to target B cell-related autoimmune responses.
Who should consider this trial
Good fit: Ideal candidates for this study are adults over 18 years old with established autoimmune conditions and a good performance status.
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 treatment could provide a novel and effective option for patients suffering from autoimmune diseases.
How similar studies have performed: Other studies have shown promising results using CAR-T cells for autoimmune diseases, indicating potential for success with this combined approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. older than 18 years of age. 2. established autoimmune conditions. 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
- 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.