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NOT YET RECRUITING
NCT06590545
PHASE1/PHASE2

Anti-CD 19 CAR-T Cell Therapy in Patients With ANCA Vasculitis

Sponsor: David Simon

View on ClinicalTrials.gov

Summary

The goal of this phase I/II clinical trial is to investigate anti-CD 19 chimeric antigen receptor T cell (CAR-T cell) therapy in patients with antineutrophil cytoplasmic antibodies (ANCA) immunoglobulin (IgG) positive ANCA associated vasculitis (AAV). The main questions it aims to answer are: * To assess the safety of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory, ANCA-IgG-positive AAV * To assess the clinical efficacy of anti-CD19 CAR-T cell therapy in subjects with active, treatment refractory ANCA-IgG-positive AAV * To assess the ANCA seroconversion rate in subjects with active, treatment refractory ANCA-IgG-positive AAV Participants will receive a single dose of KYV-101 i.v., an autologous fully-human anti-CD19 CAR-T cell immunotherapy. Follow-up time is 52 weeks with regular visits at the site.

Official title: Anti-CD 19 CAR-T Cell Therapy in Patients With ANCA Vasculitis: a Two-stage Interventional, Prospective, Open-label, Phase I/II Trial in Patients With Active, Treatment Refractory, ANCA-IgG-positive Vasculitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

8

Start Date

2025-01

Completion Date

2027-07

Last Updated

2024-09-19

Healthy Volunteers

No

Interventions

DRUG

KYV-101, an autologous fully-human anti-CD19 CAR T-cell immunotherapy

A dosage of 1x10\^8 KYV-101 CAR+ T cells will be administered intravenously as a single infusion.