CABA-201 for Active Systemic Lupus Erythematosus

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 Phase 1 Phase 2 Interventional Study
Systemic Lupus Erythematosus Lupus Nephritis
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Treatment
Participants needed
28 (estimated)
Sponsor
Cabaletta Bio · Industry
Who this trial is looking for

This trial is looking for adults with active systemic lupus erythematosus or lupus nephritis. Participants will receive the treatment CABA-201 and will be monitored for safety and effectiveness.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am between 18 and 65 years old.
  • I have been diagnosed with systemic lupus erythematosus.
  • I have positive antinuclear antibody (ANA) or anti-dsDNA antibody.
  • If I have lupus nephritis, I have active, biopsy-proven lupus nephritis class III or IV.
  • If I have non-renal lupus, I have active, moderate to severe lupus.

You may not be able to join if

  • I cannot undergo leukapheresis.
  • I have had a severe allergic reaction to certain cancer treatments.
  • I have an active infection that needs treatment.
  • I have severe symptoms from other serious health issues.
  • I have other medical conditions that could make participation risky.
  • If I have lupus nephritis, I cannot have any other kidney disease.
  • I have previously received CAR T cell therapy.
  • I have had a solid organ or stem cell transplant.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

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About This Trial

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 Locations
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Eligibility Criteria
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 s…
Contacts

Cabaletta Bio

267 759 3100

clinicaltrials@cabalettabio.com

CONTACT