RecruitingPhase 1/2

Autoimmune Disease Treatment With Mesenchymal Stem Cells (MSCs) and CAR-T Cells

China30 participantsStarted 2024-05-15

Plain-language summary

The purpose of this study is to assess the feasibility, safety and efficacy of mesenchymal stem cells (MSCs) in combination with CAR-T cells in treating autoimmune disease. Another goal of the study is to learn more about the safety and function of the MSCs combined with CAR-T cells and their long term effects in autoimmune disease patients.

Who can participate

Age range18 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. older than 18 years of age.
✓. established autoimmune conditions.
✓. the KPS score over 80 points, and survival time is more than 3 months.
✓. greater than Hgb 80 g/L.
✓. no contraindications to blood cell collection.

Exclusion criteria

✕. accompanied with other active diseases and difficult to assess treatment response.
✕. bacterial, fungal, or viral infection, unable to control.
✕. living with HIV.
✕. active HBV or HCV infection.
✕. pregnant and nursing mothers.
✕. under systemic steroid treatment within a week of the treatment.
✕. prior failed CAR-T treatment.

What they're measuring

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.

Timeframe: 1 month

Safety of 4SCAR T cells in patients with autoimmune diseases using CTCAE 5 standard to evaluate the level of adverse events

Timeframe: 12 week

Trial details

NCT IDNCT06435897

SponsorShenzhen Geno-Immune Medical Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-07-15

Contact for this trial

Lung-Ji Chang, PhD

86-0755-86725195 c@szgimi.org

View on ClinicalTrials.gov More Autoimmune Diseases trials