Evaluating CABA-201 for treating active systemic lupus erythematosus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the safety and efficacy of CABA-201, an investigational cell therapy, in patients with active systemic lupus erythematosus (SLE) and lupus nephritis (LN). Participants will be divided into two cohorts based on their condition, receiving a single dose of CABA-201 after being pretreated with standard medications, cyclophosphamide and fludarabine. The study aims to assess the therapeutic potential of this novel treatment in managing SLE symptoms and preventing organ damage.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age ≥18 and ≤65 (Adults) or Age ≥12 to \<18 years (Adolescents)
* A clinical diagnosis of SLE, based on the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria for 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.

Where it's running

• University of California Irvine
  Orange, California, United States Recruiting
• UC Davis Health
  Sacramento, California, United States Recruiting
• Mayo Clinic
  Jacksonville, Florida, United States Recruiting
• Emory University
  Atlanta, Georgia, United States Recruiting
• Northwestern Memorial Hospital
  Chicago, Illinois, United States Recruiting
• The University of Chicago Medical Center - Accepting Adult and Adolescent Patients
  Chicago, Illinois, United States Recruiting

Study contacts

• Study coordinator: Cabaletta Bio
• Email: clinicaltrials@cabalettabio.com
• Phone: 267 759 3100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Biomarker tests in adults with lupus to see how kidney disease changes over time

  Researchers will follow adults with lupus to see if blood and urine biomarkers can predict kidney involvement, flares, and treatment responses during routine care.

  Recruiting Oslo University Hospital · Oslo, Oslo · NCT07666711

• Mosunetuzumab for people with systemic lupus erythematosus

  This study tests mosunetuzumab in people with systemic lupus erythematosus, with or without active lupus nephritis.

  Recruiting at 24 sites Phase 2 Hoffmann-La Roche · CABA, Buenos Aires and 23 other locations · NCT07598396

• FT819 in Lupus Nephritis: a targeted cell therapy trial for moderate-to-severe LN

  This trial tests whether FT819, a donor-derived CAR T cell therapy, can help people with difficult-to-treat lupus nephritis who have not responded to other medicines.

  Recruiting at 12 sites Phase 2 Fate Therapeutics · Beverly Hills, California and 11 other locations · NCT07570862

• UB-VV410 for adults with active, treatment-refractory systemic lupus and lupus nephritis

  This trial will test whether UB-VV410 is safe and how it acts in adults with active, treatment-refractory systemic lupus erythematosus, including those with lupus nephritis.

  Recruiting Phase 1 Nanjing IASO Biotechnology Co., Ltd. · Nanjing · NCT07109986

• Zamtocabtagene Autologous CAR-T for Autoimmune Diseases

  This early-phase study tests whether a patient’s own CAR-T cells (zamto-cel) can be safely given after standard therapy to people with lupus or systemic sclerosis.

  Recruiting Phase 1 Miltenyi Biomedicine GmbH · Milwaukee, Wisconsin · NCT06708845

• Combination treatment for autoimmune disorders using specialized cells and chemotherapy

  This study is testing a new combination of specialized cells and chemotherapy to see if it can help people with autoimmune disorders like systemic sclerosis and lupus feel better.

  Recruiting at 2 sites Phase 1/2 M.D. Anderson Cancer Center · Houston, Texas and 1 other locations · NCT06434363

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.