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
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, CABA-201.
- Who it may be relevant to
- Registry conditions: Systemic Lupus Erythematosus, Lupus Nephritis. Basic parameters: 18 years — 65 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, Canada, Spain
- 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 Active Systemic Lupus Erythematosus
Overview
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
Detailed description
Systemic lupus erythematosus (SLE) is a chronic autoimmune disorder characterized by autoantibody production and abnormal B cell function. SLE presents with fluctuating severity and may cause tissue damage in a variety of organs over time. Lupus nephritis (LN) (renal involvement) is a common severe manifestation of SLE, which can lead to significant morbidity and mortality. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, also called resecabtagene autoleucel, or "rese-cel". Rese-cel can be given to patients with either LN or SLE without renal involvement, in two separate parallel cohorts, who have active disease. Initially a single dose of CABA-201 in patients pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU), will be evaluated. In addition, escalating doses of CABA-201 will be evaluated in patients without CY and FLU pretreatment.
Interventions
- Biological CABA-201
Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide - Biological CABA-201
Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning
Primary outcome measures
- To evaluate incidence of adverse events [Time frame: Up to 28 days after CABA-201 infusion]
Secondary outcome measures (7)
- 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 disease related biomarkers [Time frame: Up to 156 weeks]
- To evaluate disease related biomarkers [Time frame: Up to 156 Weeks]
- To evaluate efficacy [Time frame: Up to 156 Weeks]
- To evaluate efficacy [Time frame: Up to 156 weeks]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 21 centers
- University of California Irvine — Orange
- UC Davis Health — Sacramento
- Yale University — New Haven
- University of Florida Health — Gainesville
- Mayo Clinic — Jacksonville
- Emory University — Atlanta
- Northwestern Memorial Hospital — Chicago
- The University of Chicago Medical Center — Chicago
- … and 13 more centers
Canada · 1 center
- Maisonneuve-Rosemont Hospital — Montreal
Spain · 1 center
- Clinica Universitaria de Navarra — Pamplona
Identifiers
NCT: NCT06121297 · CAB-201-001