Phase 2 study of rapcabtagene autoleucel in IIM participants (CYTB323L12201)

Recruiting

• Conditions: severe refractory idiopathic inflammatory myopathies

• Registration Number: jRCT2013240052
• Lead Sponsor: Novartis Pharma. K.K.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-11-22
• Study Start: 2025-01-07
• Last Update Posted: 2025-05-09

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

• Men and women, aged >18 and =<65 years, with a diagnosis of probable or definite myositis according to American College of Rheumatology/European League Against Rheumatism 2017 (ACR/EULAR 2017) criteria
• Participants who had inadequate response to prior therapy
• Diagnosed with active disease
• Participant must meet criteria for severe myositis

Exclusion Criteria

• Any condition during Screening that could prevent a complete washout of medications or could otherwise make the participant ineligible for anti-CD19 CAR-T therapy and further participation in the study
• BMI at Screening of =<18.5 or >=35 kg/m2
• Severe muscle damage at Screening
• Inadequate organ function
• Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
• Other inflammatory and non-inflammatory myopathies
• Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy
• Other protocol-defined inclusion/exclusion criteria may apply.

Study & Design

• Study Type: Interventional
• Study Design: parallel assignment

Primary Outcome Measures

Name	Time	Method
Total Improvement Score (TIS)	Week 52	Proportion of participants achieving at least moderate improvement