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

Launched by CABALETTA BIO · Nov 1, 2023

Keywords

ClinConnect Summary

The RESET-SLE trial is studying a new treatment called CABA-201 for people with active Systemic Lupus Erythematosus (SLE), including those with a specific kidney-related form known as Lupus Nephritis. This study aims to see how safe and effective CABA-201 is for adults aged 18 to 65 who have been diagnosed with SLE based on certain medical guidelines. To participate, individuals must have certain test results showing their lupus is active, and those with Lupus Nephritis need to have been diagnosed with specific types of kidney involvement.

Participants in this trial will receive the new treatment and will be closely monitored by healthcare professionals to track their health and any side effects. It’s important for potential participants to know that there are specific eligibility criteria, meaning not everyone can join. For example, those with severe infections or certain other medical conditions may not be eligible. Overall, this trial could help advance our understanding of lupus treatments and may offer hope for better management of this challenging condition.

Gender

ALL

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.