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

NCT06590545 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

  • ANCA-IgG-positive ANCA Associated Vasculitis

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.

Sponsors & Collaborators

  • Kyverna Therapeutics

    collaborator INDUSTRY

  • David Simon

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-31
Primary Completion
2027-01-31
Completion
2027-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06590545 on ClinicalTrials.gov