RECRUITING

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Description

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
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Related Conditions:

Idiopathic Inflammatory Myopathies

Study Overview

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Study Details

Study overview

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)

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)

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Condition
Idiopathic Inflammatory Myopathies
Intervention / Treatment

-

Contacts and Locations

Iowa City

University Of Iowa, Iowa City, Iowa, United States, 52242

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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
  • 2. Participants who had inadequate response to prior therapy
  • 3. Diagnosed with active disease
  • 4. Participant must meet criteria for severe myositis
  • 1. 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
  • 2. BMI at Screening of ≤18.5 or ≥35 kg/m2
  • 3. Severe muscle damage at Screening
  • 4. Inadequate organ function
  • 5. Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
  • 6. Other inflammatory and non-inflammatory myopathies
  • 7. Any medical conditions that are not related to IIM that would jeopardize the ability of the participant to tolerate CD19 CAR-T cell therapy

Ages Eligible for Study

18 Years to 65 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Novartis Pharmaceuticals,

Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

2030-06-01