RECRUITING

RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Conditions

Idiopathic Inflammatory Myopathy Dermatomyositis Anti-Synthetase Syndrome Immune-Mediated Necrotizing Myopathy Juvenile Dermatomyositis Juvenile Polymyositis Juvenile Idiopathic Inflammatory Myopathy (JIIM)Juvenile Myositis CABA-201 Autoimmune Disease Anti-CD19 CAR-T therapy Cellular Therapy Myositis

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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

RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Official Title

A Phase 1/2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy

Quick Facts

Study Start:2023-12-20

Study Completion:2028-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06154252

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:6 Years to 75 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥18 and ≤75 * A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria * Diagnosis of DM, ASyS, IMNM based on the presence of serum myositis-specific antibodies * Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography * Presence of muscle weakness	* Contraindication to leukapheresis * History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites * Active infection requiring medical intervention at screening * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections. * Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures * Significant lung or cardiac impairment * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Inclusion Criteria

Exclusion Criteria

* Age ≥18 and ≤75
* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism/American College of Rheumatology classification criteria
* Diagnosis of DM, ASyS, IMNM based on the presence of serum myositis-specific antibodies
* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography
* Presence of muscle weakness

* Contraindication to leukapheresis
* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
* Active infection requiring medical intervention at screening
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
* Significant lung or cardiac impairment
* Previous CAR T cell therapy
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Contacts and Locations

Study Contact

Cabaletta Bio

CONTACT

267-759-3100

clinicaltrials@cabalettabio.com

Principal Investigator

Medical Director

STUDY_CHAIR

Cabaletta Bio

Study Locations (Sites)

University of California Irvine - Accepting Adult Patients

Orange, California, 92868

United States

Mayo Clinic Florida - Accepting Adult Patients

Jacksonville, Florida, 32224

United States

Northwestern Memorial Hospital - Accepting Adult Patients

Chicago, Illinois, 60611

United States

The University of Chicago Medical Center - Accepting Adult and Juvenile Patients

Chicago, Illinois, 60637

United States

University of Kansas Medical Center - Accepting Adult Patients

Kansas City, Kansas, 66160

United States

Mayo Clinic - Accepting Adult Patients

Rochester, Minnesota, 55902

United States

Oregon Health & Science University - Accepting Adult Patients

Portland, Oregon, 97239

United States

Vanderbilt University Medical Center - Accepting Adult Patients

Nashville, Tennessee, 37232

United States

Houston Methodist Hospital - Accepting Adult Patients

Houston, Texas, 77030

United States

University of Texas MD Anderson Cancer Center - Accepting Adult Patients

Houston, Texas, 77030

United States

Collaborators and Investigators

Sponsor: Cabaletta Bio

Medical Director, STUDY_CHAIR, Cabaletta Bio

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 Date2023-12-20

Study Completion Date2028-07

Study Record Updates

Study Start Date2023-12-20

Study Completion Date2028-07

Terms related to this study

Keywords Provided by Researchers

CABA-201
Autoimmune Disease
Anti-CD19 CAR-T therapy
Cellular Therapy
Idiopathic Inflammatory Myopathy
Myositis
Dermatomyositis
Anti-synthetase Syndrome
Immune-mediated Necrotizing Myopathy
Juvenile Dermatomyositis
Juvenile Polymyositis
Juvenile Idiopathic Inflammatory Myopathy (JIIM)
Juvenile Myositis

Additional Relevant MeSH Terms

Idiopathic Inflammatory Myopathy
Dermatomyositis
Anti-Synthetase Syndrome
Immune-Mediated Necrotizing Myopathy
Juvenile Dermatomyositis
Juvenile Polymyositis
Juvenile Idiopathic Inflammatory Myopathy (JIIM)
Juvenile Myositis