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
- Non-Randomized
- Intervention Model
- Sequential Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental CABA-201 with FLU/CY Preconditioning |
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 non-renal SLE who do not meet criteria for inclusion in the LN cohort Expansion Cohort: Infusion of CABA-201 with preconditioning in subjects with LN and SLE |
|
|
Experimental CABA-201, No Preconditioning |
Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE |
|
Recruiting Locations
University of California Irvine
Orange 5379513, California 5332921 92868
Orange 5379513, California 5332921 92868
UC Davis Health
Sacramento 5389489, California 5332921 95817
Sacramento 5389489, California 5332921 95817
Yale University
New Haven 4839366, Connecticut 4831725 06520
New Haven 4839366, Connecticut 4831725 06520
Mayo Clinic
Jacksonville 4160021, Florida 4155751 32224
Jacksonville 4160021, Florida 4155751 32224
Emory University
Atlanta 4180439, Georgia 4197000 30322
Atlanta 4180439, Georgia 4197000 30322
Northwestern Memorial Hospital
Chicago 4887398, Illinois 4896861 60611
Chicago 4887398, Illinois 4896861 60611
The University of Chicago Medical Center
Chicago 4887398, Illinois 4896861 60637
Chicago 4887398, Illinois 4896861 60637
University of Kansas Medical Center
Kansas City 4273837, Kansas 4273857 66160
Kansas City 4273837, Kansas 4273857 66160
Tufts Medical Center
Boston 4930956, Massachusetts 6254926 02111
Boston 4930956, Massachusetts 6254926 02111
Massachusetts General Hospital
Boston 4930956, Massachusetts 6254926 02114
Boston 4930956, Massachusetts 6254926 02114
Boston Children's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
Brigham and Women's Hospital
Boston 4930956, Massachusetts 6254926 02115
Boston 4930956, Massachusetts 6254926 02115
UMass Memorial Hospital
Worcester 4956184, Massachusetts 6254926 01655
Worcester 4956184, Massachusetts 6254926 01655
University of Minnesota
Minneapolis 5037649, Minnesota 5037779 55414
Minneapolis 5037649, Minnesota 5037779 55414
University of Rochester
Rochester 5134086, New York 5128638 14642
Rochester 5134086, New York 5128638 14642
UNC Chapel Hill
Chapel Hill 4460162, North Carolina 4482348 27599
Chapel Hill 4460162, North Carolina 4482348 27599
Children's Hospital of Philadelphia
Philadelphia 4560349, Pennsylvania 6254927 19104
Philadelphia 4560349, Pennsylvania 6254927 19104
Medical University of South Carolina
Charleston 4574324, South Carolina 4597040 29425
Charleston 4574324, South Carolina 4597040 29425
University of Texas MD Anderson Cancer Center
Houston 4699066, Texas 4736286 77030
Houston 4699066, Texas 4736286 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, 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.