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

NCT06435897 | Recruiting Phase 1

• 1 other identifier: GIMI-IRB-24003
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autoimmune Diseases

Keywords

CAR-T; MSC; autoimmune disease; autoantibody; B cell; plasma cell; CD19; BCMA

Outcome Measures

Primary Outcomes (2)

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

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

  1 month

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

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

  12 week

Secondary Outcomes (4)

• Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects

  6 months

• The activity of 4SCAR T cells in patients with autoimmune diseases

  1 year

• The activity of 4SCAR T cells in patients with autoimmune diseases

  1 year

• The activity of 4SCAR T cells in patients with autoimmune diseases

  1 year year

Study Arms (1)

MSC combined with 4SCAR T-cell therapy for autoimmune diseases

EXPERIMENTAL

nfusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV

Biological: fetal MSCs combined with 4SCAR T cells

Interventions

fetal MSCs combined with 4SCAR T cells BIOLOGICAL

Infusion of 4SCAR T cells at 10\^6 cells/kg body weight and MSCs at 3x10\^6 cells via IV

MSC combined with 4SCAR T-cell therapy for autoimmune diseases

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shenzhen Geno-Immune Medical Institute: lead

Study Sites (1)

Shenzhen Geno-immune Medical Institute

Shenzhen, Guangdong, 518000, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Lung-Ji Chang, PhD

CONTACT

86-0755-86725195; c@szgimi.org

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2024
• First Posted: May 30, 2024
• Study Start: May 15, 2024
• Primary Completion (Estimated): July 15, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)