Phase 2 study of rapcabtagene autoleucel in IIM participants

JRCT ID: jRCT2013240052

Registered date:22/11/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: severe refractory idiopathic inflammatory myopathies
• Date of first enrollment: 25/11/2024
• Target sample size: 15
• Countries of recruitment: Singapore,Japan,United States,Japan,State of Israel,Japan
• Study type: Interventional

Intervention(s)

Experimental: Rapcabtagene autoleucel
Single infusion of rapcabtagene autoleucel (YTB323)

Active Comparator: Comparator
Investigator choice of treatment as per protocol

Outcome(s)

• Primary Outcome: Proportion of participants achieving at least moderate improvement in Total Improvement Score (TIS) at Week 52

Key inclusion & exclusion criteria

• Age minimum: > 18age old
• Age maximum: <= 65age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Yamauchi Kyosuke
• Secondary ID(s): NCT06665256