NCT06121297

Brief Summary

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

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at P25-P50 for phase_1

Timeline
44mo left

Started Feb 2024

Longer than P75 for phase_1

Geographic Reach
3 countries

23 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
Feb 2024Dec 2029

First Submitted

Initial submission to the registry

October 23, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

November 7, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

February 16, 2024

Completed
5.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2029

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

5.8 years

First QC Date

October 23, 2023

Last Update Submit

April 7, 2026

Conditions

Systemic Lupus ErythematosusLupus Nephritis

Keywords

CABA-201Autoimmune DiseaseAnti-CD19 CAR-T therapyCellular TherapySystemic Lupus ErythematosusLupus Nephritis

Outcome Measures

Primary Outcomes (1)

  • To evaluate incidence of adverse events

    Up to 28 days after CABA-201 infusion

Secondary Outcomes (7)

  • To evaluate adverse events and laboratory abnormalities

    Up to 156 weeks

  • To characterize the pharmacodynamics (PD)

    Up to 156 weeks

  • To characterize the pharmacokinetics (PK)

    Up to 156 weeks

  • To evaluate disease related biomarkers

    Up to 156 weeks

  • To evaluate disease related biomarkers

    Up to 156 Weeks

  • +2 more secondary outcomes

Study Arms (2)

CABA-201 with FLU/CY Preconditioning

EXPERIMENTAL

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

Biological: CABA-201

CABA-201, No Preconditioning

EXPERIMENTAL

Infusion of CABA-201 with no preconditioning in subjects with LN and non-renal SLE

Biological: CABA-201

Interventions

CABA-201BIOLOGICAL

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

CABA-201 with FLU/CY Preconditioning

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (23)

University of California Irvine

Orange, California, 92868, United States

RECRUITING

UC Davis Health

Sacramento, California, 95817, United States

RECRUITING

Yale University

New Haven, Connecticut, 06520, United States

RECRUITING

University of Florida Health

Gainesville, Florida, 32610, United States

ACTIVE NOT RECRUITING

Mayo Clinic

Jacksonville, Florida, 32224, United States

RECRUITING

Emory University

Atlanta, Georgia, 30322, United States

RECRUITING

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

RECRUITING

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

RECRUITING

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

RECRUITING

Tufts Medical Center

Boston, Massachusetts, 02111, United States

RECRUITING

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

UMass Memorial Hospital

Worcester, Massachusetts, 01655, United States

RECRUITING

University of Minnesota

Minneapolis, Minnesota, 55414, United States

RECRUITING

Columbia University Irving Medical Center

New York, New York, 10032, United States

WITHDRAWN

University of Rochester

Rochester, New York, 14642, United States

RECRUITING

UNC Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Maisonneuve-Rosemont Hospital

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

Clinica Universitaria de Navarra

Pamplona, Navarre, 31008, Spain

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, SystemicLupus NephritisAutoimmune Diseases

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesImmune System DiseasesGlomerulonephritisNephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Medical Director

    Cabaletta Bio

    STUDY CHAIR

Central Study Contacts

Cabaletta Bio

CONTACT

267 759 3100clinicaltrials@cabalettabio.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 23, 2023

First Posted

November 7, 2023

Study Start

February 16, 2024

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

December 1, 2029

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)US(21)ES(1)