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CARTIMMUNE: Study of Patients With Autoimmune Diseases Receiving KYV-101

NCT06152172 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2026-02-18

No results posted yet for this study

Summary

The purpose of this study is to assess the safety, tolerability, and clinical activity of KYV 101 (a fully-human anti-CD19 CAR T-cell therapy) in adult subjects with B cell-driven autoimmune diseases. The trial anticipates enrolling participants to reach a maximum of 24 participants who will receive 1 dose of KYV-101 and will be followed for 2 years.

Conditions

  • Idiopathic Inflammatory Myopathies
  • Diffuse Cutaneous Systemic Sclerosis
  • SLE Nephritis
  • ANCA Associated Vasculitis

Interventions

DRUG

KYV-101

The KYV-101 will be administered IV as a single infusion dosed at 1×108 CAR+ T cells.

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy of cyclophosphamide (CYC) 300 mg/m2

DRUG

Fludarabine

Lymphodepleting chemotherapy of Fludarabine (FLU) 30 mg/m2 intravenously (IV)

Sponsors & Collaborators

  • Kyverna Therapeutics

    collaborator INDUSTRY

  • David Porter

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-05
Primary Completion
2027-02-28
Completion
2027-02-28
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT06152172 on ClinicalTrials.gov