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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-16

Study Completion Date

2027-12-31

Brief Summary

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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

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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.

Conditions

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Systemic Lupus Erythematosus Lupus Nephritis

Keywords

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CABA-201 Autoimmune Disease Anti-CD19 CAR-T therapy Cellular Therapy Systemic Lupus Erythematosus Lupus Nephritis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single group assignment in two parallel cohorts

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

CABA-201

Intervention Type BIOLOGICAL

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Interventions

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CABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_CHAIR

Cabaletta Bio

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CAB-201-001

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

CABA-201

CABA-201

Interventions

CABA-201

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Cabaletta Bio

Responsible Party

Principal Investigators

Medical Director

Locations

University of California Irvine

UC Davis Health

Yale University

University of Florida Health

Mayo Clinic

Emory University

Northwestern Memorial Hospital

The University of Chicago Medical Center

University of Kansas Medical Center

Tufts Medical Center

Massachusetts General Hospital

Boston Children's Hospital

Brigham and Women's Hospital

UMass Memorial Hospital

University of Minnesota

Columbia University Irving Medical Center

University of Rochester

UNC Chapel Hill

Children's Hospital of Philadelphia

Medical University of South Carolina

University of Texas MD Anderson Cancer Center

Maisonneuve-Rosemont Hospital

Clinica Universitaria de Navarra

Countries

Central Contacts

Cabaletta Bio

Facility Contacts

Alpha Clinic

Tammy Yotter

Fotios Koumpouras, M.D.

Wesley Dillinger

John Varghese

Matthew Selle

Dr. Cuoghi Edens, MD, FAAP

Theresa Howard

Latoya Marshall

Angela Chavez

Ben Bennett

Bridget Kerwin

Joyce Chang, MD

Olivia Gabriel

Cancer Research Office

Patrick Nackman, MD

Tyler Cavin

Shruti Saxena Beem

Roger Huamani

[email protected]

[email protected]

Melissa Cunningham, MD, PhD

Doris Soebbing, BS, RN, BSN

Karine Chaussé

José Mora

Other Identifiers

CAB-201-001