A Study of C-CAR168 in the Treatment of Autoimmune Diseases Refractory to Standard Therapy

Last updated: October 20, 2024
Sponsor: RenJi Hospital
Overall Status: Active - Recruiting

Phase

1

Condition

Systemic Lupus Erythematosus

Collagen Vascular Diseases

Connective Tissue Diseases

Treatment

CD20/BCMA-directed CAR-T cells

Clinical Study ID

NCT06249438
1141-043(CAR-AID)
  • Ages 18-70
  • All Genders

Study Summary

This is an investigator-initiated, multicenter, open-label study of C-CAR168, an autologous bi-specific CAR-T therapy targeting CD20 and BCMA, for the treatment of adult patients with autoimmune diseases refractory to standard therapy

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • 18 to 70 years old at the time of signing the Informed Consent Form (ICF).

  • Diagnosed as SLE/Immune-Mediated Necrotizing Myopathy (IMNM)/Neuromyelitis OpticaSpectrum Disorders (NMOSD)/Multiple Sclerosis (MS)/Myasthenia Gravis (MG) accordingto recognized diagnostic criteria for at least 6 months.

  • Remains disease active or relapses after treatment with standard of care therapy forat least 8 weeks with the dose stable for more than 2 weeks; patients should havebeen treated at least two immunosuppressants (immunosuppressants ordisease-modifying drug (DMD) for MS participants).

  • Adequate bone marrow, coagulation, cardiopulmonary, liver and renal function.

Exclusion

Exclusion Criteria:

  • Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive.

  • Uncontrolled active infection.

  • Live vaccine injection within 4 weeks prior to signing the ICF.

  • Major organ transplantation history or bone marrow/hematopoietic stem celltransplantation history.

  • Severe cardiovascular diseases within the past 6 months prior to screening.

  • ≥ Grade 2 bleeding within the past 30 days prior to screening, or requiringlong-term anticoagulants treatment.

  • Inadequate washing time for previous treatment.

  • Previously treated with CAR-T cell products or genetically modified T celltherapies.

  • Pregnant or lactating women.

  • Severe central nervous system diseases or pathological changes.

  • Malignancy history within 5 years prior to signing the ICF.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: CD20/BCMA-directed CAR-T cells
Phase: 1
Study Start date:
March 20, 2024
Estimated Completion Date:
March 31, 2040

Connect with a study center

  • Department of Rheumatology, RenJi Hospital, School of Medicine, Shanghai JiaoTong University

    Shanghai, Shanghai 200001
    China

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.