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Phase 2 Study of Rapcabtagene Autoleucel in Myositis

NCT06665256 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-05-22

No results posted yet for this study

Summary

A Phase 2, randomized, open-label, controlled study to evaluate the efficacy and safety of rapcabtagene autoleucel versus comparator in participants with severe refractory idiopathic inflammatory myopathies (IIM)

Conditions

  • Idiopathic Inflammatory Myopathies

Interventions

BIOLOGICAL

Rapcabtagene autoleucel

Single infusion of rapcabtagene autoleucel after lymphodepleting therapy with fludarabine (adjusted based on renal impairment) and cyclophosphamide daily for 3 days.

OTHER

Active Comparator Option

Investigator choice of treatment as per protocol

Sponsors & Collaborators

Principal Investigators

  • Novartis Pharmaceuticals · Novartis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-12-17
Primary Completion
2029-03-09
Completion
2032-11-29
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Brazil
  • France
  • Germany
  • Israel
  • Italy
  • Japan
  • Netherlands
  • Saudi Arabia
  • Singapore
  • Spain
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

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 NCT06665256 on ClinicalTrials.gov