RECRUITING

RESET-SSc: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T Cell Therapy, in Subjects With Systemic Sclerosis

Conditions

Systemic Sclerosis Scleroderma CABA-201 autoimmune disease anti-CD19 CAR-T therapy

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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-SSc: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201, a CD19-CAR T cell therapy, in Subjects with Systemic Sclerosis

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 Systemic Sclerosis

Quick Facts

Study Start:2024-07-02

Study Completion:2029-07

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06328777

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 70 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Age ≥18 and ≤70 * A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria. * Early active disease * Evidence of significant skin, pulmonary, renal, or cardiac involvement	* 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 visit * 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 * Severe 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 ≤70
* A clinical diagnosis of SSc, based on the 2013 American College of Rheumatology and European League Against Rheumatism classification criteria.
* Early active disease
* Evidence of significant skin, pulmonary, renal, or cardiac involvement

* 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 visit
* 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
* Severe 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_DIRECTOR

Cabaletta Bio

Study Locations (Sites)

Northwestern Memorial Hospital

Chicago, Illinois, 60611

United States

The University of Chicago Medical Center

Chicago, Illinois, 60637

United States

University of Michigan

Ann Arbor, Michigan, 48109

United States

Columbia University Irving Medical Center

New York, New York, 10032

United States

Duke University

Durham, North Carolina, 27710

United States

Collaborators and Investigators

Sponsor: Cabaletta Bio

Medical Director, STUDY_DIRECTOR, 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 Date2024-07-02

Study Completion Date2029-07

Study Record Updates

Study Start Date2024-07-02

Study Completion Date2029-07

Terms related to this study

Keywords Provided by Researchers

CABA-201
autoimmune disease
anti-CD19 CAR-T therapy
systemic sclerosis
scleroderma

Additional Relevant MeSH Terms

Systemic Sclerosis
Scleroderma