RECRUITING

Phase 2 Study of Rapcabtagene Autoleucel in Myositis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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)

Official Title

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)

Quick Facts

Study Start:2024-12-31
Study Completion:2030-06-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06665256

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.

Ages Eligible for Study:18 Years to 65 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Participants who had inadequate response to prior therapy
  3. 3. Diagnosed with active disease
  4. 4. Participant must meet criteria for severe myositis
  1. 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. 2. BMI at Screening of ≤18.5 or ≥35 kg/m2
  3. 3. Severe muscle damage at Screening
  4. 4. Inadequate organ function
  5. 5. Hypersensitivity and/or contraindications to any product (including its ingredients) to be given to the participant as per the study protocol
  6. 6. Other inflammatory and non-inflammatory myopathies
  7. 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

Contacts and Locations

Study Contact

Novartis Pharmaceuticals
CONTACT
1-888-669-6682
novartis.email@novartis.com
Novartis Pharmaceuticals
CONTACT
+41613241111
novartis.email@novartis.com

Principal Investigator

Novartis Pharmaceuticals
STUDY_DIRECTOR
Novartis Pharmaceuticals

Study Locations (Sites)

University Of Iowa
Iowa City, Iowa, 52242
United States

Collaborators and Investigators

Sponsor: Novartis Pharmaceuticals

  • Novartis Pharmaceuticals, STUDY_DIRECTOR, Novartis Pharmaceuticals

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-31
Study Completion Date2030-06-01

Study Record Updates

Study Start Date2024-12-31
Study Completion Date2030-06-01

Terms related to this study

Keywords Provided by Researchers

  • Chimeric Antigen Receptor T cells (CAR-T)
  • rapcabtagene autoleucel
  • idiopathic inflammatory myopathies (IIM)
  • dermatomyositis
  • Anti-Synthetase Syndrome
  • Immune-Mediated Necrotizing Myopathy
  • Interstitial Lung Disease

Additional Relevant MeSH Terms

  • Idiopathic Inflammatory Myopathies