NCT06121297 RESET-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
| NCT ID | NCT06121297 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Cabaletta Bio |
| Condition | Systemic Lupus Erythematosus |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2024-02-16 |
| Primary Completion | 2029-12 |
Eligibility & Interventions
Eligibility Fast-Check
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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 28 participants in total. It began in 2024-02-16 with a primary completion date of 2029-12.
⚠ 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-SLE: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Systemic Lupus Erythematosus
Eligibility Criteria
Inclusion Criteria: * Age ≥18 and ≤65 * A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for adult SLE. * Positive antinuclear antibody (ANA) titer or anti-dsDNA antibody at screening. * For LN subjects only, active, biopsy-proven LN class III or IV, with or without the presence of class V, according to 2018 Revised International Society of Nephrology/Renal Pathology Society (ISN/RPS) criteria * For non-renal SLE subjects only: Active, moderate to severe SLE 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 * 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 * For LN subjects only: The presence of kidney disease other than active lupus nephritis * Previous CAR T cell therapy * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant.
Contact & Investigator
Medical Director
STUDY CHAIR
Cabaletta Bio
Frequently Asked Questions
Who can join the NCT06121297 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Systemic Lupus Erythematosus. 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 NCT06121297 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 NCT06121297 currently recruiting?
Yes, NCT06121297 is actively recruiting participants. Contact the research team at clinicaltrials@cabalettabio.com for enrollment information.
Where is the NCT06121297 trial being conducted?
This trial is being conducted at Orange, United States, Sacramento, United States, New Haven, United States, Gainesville, United States and 11 additional locations.
Who is sponsoring the NCT06121297 clinical trial?
NCT06121297 is sponsored by Cabaletta Bio. The principal investigator is Medical Director at Cabaletta Bio. The trial plans to enroll 28 participants.
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