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Recruiting NCT06328777

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

Phase I / Phase II Interventional Systemic Sclerosis Scleroderma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: CABA-201.
Who it may be relevant to
Registry conditions: Systemic Sclerosis, Scleroderma. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

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

Detailed description

Systemic sclerosis (SSc), also known as scleroderma , is a rare autoimmune disorder characterized by autoantibody production and abnormal B cell function. Though the cause of SSc is not well understood, it is thought to involve B cells that cause the body to attack different tissues in one's own body, causing skin and organ fibrosis. This study is being conducted to evaluate the safety and efficacy of an investigational therapy, CABA-201, a CD19-CAR T cell therapy, that can be given to patients with SSc who have active disease. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.

Interventions

  • Biological CABA-201
    Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Primary outcome measures

  • To evaluate incidence of adverse events [Time frame: Up to 28 days after CABA-201 infusion]
Secondary outcome measures (4)
  • To evaluate adverse events and laboratory abnormalities [Time frame: Up to 156 weeks]
  • To characterize the pharmacodynamics (PD) [Time frame: Up to 156 weeks]
  • To characterize the pharmacokinetics (PK) [Time frame: Up to 156 weeks]
  • To evaluate efficacy [Time frame: Up to 156 weeks]

Eligibility criteria

Inclusion criteria

  • Age ≥18 and ≤75
  • 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

Exclusion criteria

  • 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

Other protocol-defined inclusion/exclusion criteria may apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 10 centers
  • Yale University — New Haven
  • Mayo Clinic Florida — Jacksonville
  • Northwestern Memorial Hospital — Chicago
  • The University of Chicago Medical Center — Chicago
  • University of Kansas Medical Center — Kansas City
  • University of Michigan — Ann Arbor
  • Mayo Clinic Rochester — Rochester
  • Columbia University Irving Medical Center — New York
  • … and 2 more centers

Identifiers

NCT: NCT06328777 · CAB-201-003

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗