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

Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-75
SponsorShenzhen Geno-Immune Medical Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • fetal MSCs combined with 4SCAR T cells

    Biological/Vaccine

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

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: MSC combined with 4SCAR T-cell therapy for autoimmune diseasesExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 month
2

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

Time frame
12 week

Secondary outcomes

1

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

Number of participants with reduced symptoms or stabilized conditions after treatment assessed by short term clinical effects using study assessment table.

Time frame
6 months
2

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

B cell and immunoglobulin suppression activity of 4SCAR T cells in patients with autoimmune diseases

Time frame
1 year
3

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

CAR copies in patients with autoimmune diseases

Time frame
1 year
4

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

The immunoglobulin levels in patients with autoimmune diseases

Time frame
1 year year

Other outcomes

Sponsors and contacts

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