Back to search results

RESET-SLE: CABA-201 for Active Systemic Lupus Erythematosus

This study is looking at an investigational cell therapy called CABA-201 (also known as resecabtagene autoleucel or rese-cel) for people with active Systemic Lupus Erythematosus (SLE) or Lupus Nephritis (LN). SLE is a long-term autoimmune disease where your immune system attacks your own tissues. LN is when SLE affects your kidneys. The study will test how safe and effective CABA-201 is. Some participants will receive a single infusion of CABA-201 after receiving other medicines (fludarabine and cyclophosphamide), while others will receive CABA-201 at different doses without those other medicines. You might be able to join if you are 18 to 65 years old, have a diagnosis of SLE, and have specific antibodies (ANA or anti-dsDNA). The study aims to see how many side effects occur within 28 days after getting CABA-201. About 28 people are expected to participate.

Study design
This is an open-label study, meaning you and your doctors will know which treatment you are receiving. It is a Phase 1/2 study, which typically means it's an early-stage study looking at safety and initial effectiveness. About 28 people are expected to participate.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The primary safety endpoint is measured up to 28 days after the CABA-201 infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06121297

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

Recruiting
PHASE1Ages 18–65InterventionalTreatment
Cabaletta Bio
~28 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:CABA-201

At a glance

Recruiting sites
20 of 23 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
To evaluate incidence of adverse events
Measured over Up to 28 days after CABA-201 infusion

Conditions

Systemic Lupus Erythematosus
Lupus Nephritis

Explore related trials

Lupus GlomerulonephritisSystemic Lupus ErythematosusAnti-ds DNA Antibody

Where it's being run

23 sites across 15 states
Massachusetts5
California2
Florida2
Illinois2
New York2
Connecticut1
Georgia1
Kansas1

Study leadership

  • Medical Director · STUDY_CHAIR · Cabaletta Bio

Who to contact

Cabaletta Bio
[email protected]
267 759 3100 · ext. 4444
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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.

What this trial measures

  • To evaluate incidence of adverse eventsUp to 28 days after CABA-201 infusion