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

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

Conditions

Systemic Sclerosis, Scleroderma

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Study Overview

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Study Details

Study overview

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

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

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

Condition
Systemic Sclerosis
Intervention / Treatment

-

Contacts and Locations

Chicago

Northwestern Memorial Hospital, Chicago, Illinois, United States, 60611

Chicago

The University of Chicago Medical Center, Chicago, Illinois, United States, 60637

Ann Arbor

University of Michigan, Ann Arbor, Michigan, United States, 48109

New York

Columbia University Irving Medical Center, New York, New York, United States, 10032

Durham

Duke University, Durham, North Carolina, United States, 27710

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

  • * 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

Ages Eligible for Study

18 Years to 70 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Cabaletta Bio,

Medical Director, STUDY_DIRECTOR, Cabaletta Bio

Study Record Dates

2029-07