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
| NCT ID | NCT06328777 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cabaletta Bio |
| Condition | Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2024-07-02 |
| Primary Completion | 2029-07 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 12 participants in total. It began in 2024-07-02 with a primary completion date of 2029-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Medical Director
STUDY DIRECTOR
Cabaletta Bio
Frequently Asked Questions
Who can join the NCT06328777 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Systemic Sclerosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06328777 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06328777 currently recruiting?
Yes, NCT06328777 is actively recruiting participants. Contact the research team at clinicaltrials@cabalettabio.com for enrollment information.
Where is the NCT06328777 trial being conducted?
This trial is being conducted at New Haven, United States, Jacksonville, United States, Chicago, United States, Chicago, United States and 6 additional locations.
Who is sponsoring the NCT06328777 clinical trial?
NCT06328777 is sponsored by Cabaletta Bio. The principal investigator is Medical Director at Cabaletta Bio. The trial plans to enroll 12 participants.