IM19 CAR-T Cell Therapy for IgA Nephropathy Patients and Membranous Nephropathy Patients

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorBeijing Immunochina Medical Science & Technology Co., Ltd.

About this trial

IM19 CAR-T cell therapy for IgA nephropathy patients with urinary protein and renal dysfunction, as well as patients with intermediate to high-risk primary membranous nephropathy

Eligibility criteria

Qualifiers

IgA nephropathy

IgA nephropathy diagnosed through renal biopsy

When screening, urine protein should be ≥0.5g/gCr and 20mL/min/1.73m²≤eGFR<60mL/min/1.73m²

Age≥18years old

Disqualifiers

Kidney diseases other than IgA nephropathy, as well as primary and secondary nephrotic syndrome

After examination by the researchers, it was determined that the subjects had diseases that were not suitable for participation in this study, such as life-threatening conditions (such as catastrophic antiphospholipid syndrome, acute severe renal failure, and acute severe central nervous system disease manifestations)

Serious complications unrelated to IgA nephropathy

Use or increase the dosage of corticosteroids, immunosuppressants, biologics (including but not limited to CD20 monoclonal antibodies, taceptil, etc.), anticoagulants (warfarin), and n-3 fatty acids (fish oil) for the drug treatment of IgA nephropathy within 3 months

Trial design

Treatments tested in this trial

  • IM19 chimeric antigen receptor T cell injection

Treatment groups

12 Participants
are divided into 2 treatment groups

Locations

This trial has no locations