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
Purpose
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
Conditions
- Systemic Lupus Erythematosus
- Lupus Nephritis
Eligibility
- Eligible Ages
- Between 18 Years and 65 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Phase 1/Phase 2
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Intervention Model Description
- Single group assignment in two parallel cohorts
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CABA-201 |
LN Cohort: Infusion of CABA-201 with preconditioning in subjects with LN Non-renal SLE Cohort: Infusion of CABA-201 with preconditioning in subjects with SLE who do not meet criteria for inclusion in the LN cohort |
|
Recruiting Locations
University of California Irvine
Orange, California 92868
Orange, California 92868
UC Davis Health
Sacramento, California 95817
Sacramento, California 95817
Yale University
New Haven, Connecticut 06520
New Haven, Connecticut 06520
University of Florida Health
Gainesville, Florida 32610
Gainesville, Florida 32610
Mayo Clinic
Jacksonville, Florida 32224
Jacksonville, Florida 32224
Northwestern Memorial Hospital
Chicago, Illinois 60611
Chicago, Illinois 60611
The University of Chicago Medical Center
Chicago, Illinois 60637
Chicago, Illinois 60637
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
Tufts Medical Center
Boston, Massachusetts 02111
Boston, Massachusetts 02111
Massachusetts General Hospital
Boston, Massachusetts 02114
Boston, Massachusetts 02114
Boston Children's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
Brigham and Women's Hospital
Boston, Massachusetts 02115
Boston, Massachusetts 02115
UMass Memorial Hospital
Worcester, Massachusetts 01655
Worcester, Massachusetts 01655
University of Minnesota
Minneapolis, Minnesota 55414
Minneapolis, Minnesota 55414
Columbia University Irving Medical Center
New York, New York 10032
New York, New York 10032
University of Rochester
Rochester, New York 14642
Rochester, New York 14642
UNC Chapel Hill
Chapel Hill, North Carolina 27599
Chapel Hill, North Carolina 27599
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
Medical University of South Carolina
Charleston, South Carolina 29425
Charleston, South Carolina 29425
University of Texas MD Anderson Cancer Center
Houston, Texas 77030
Houston, Texas 77030
More Details
- NCT ID
- NCT06121297
- Status
- Recruiting
- Sponsor
- Cabaletta Bio
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, that can be given to patients with either LN or SLE without renal involvement, in two separate parallel cohorts, who have active disease. A single dose of CABA-201 in patients who are pretreated with a standard regimen including cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.