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RECRUITING Phase 1

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

NCT06121297 · View on ClinicalTrials.gov ↗

Study 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

Interventions

  • BIOLOGICAL CABA-201

Study Locations (20)

Massachusetts

  • Tufts Medical Center — Boston
  • Massachusetts General Hospital — Boston
  • Boston Children's Hospital — Boston
  • Brigham and Women's Hospital — Boston
  • UMass Memorial Hospital — Worcester

California

  • University of California Irvine — Orange
  • UC Davis Health — Sacramento

Florida

  • University of Florida Health — Gainesville
  • Mayo Clinic — Jacksonville

Illinois

  • Northwestern Memorial Hospital — Chicago
  • The University of Chicago Medical Center — Chicago

New York

  • Columbia University Irving Medical Center — New York
  • University of Rochester — Rochester

Connecticut

  • Yale University — New Haven

Georgia

  • Emory University — Atlanta

Kansas

  • University of Kansas Medical Center — Kansas City

Trial Details

FieldValue
Enrollment Target 28 participants
Start Date 2024-02-16
Est. Completion 2029-12
Phase Phase 1

Sponsor

Cabaletta Bio

5 total trials

Interested in This Trial?

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06121297

The ClinicalTrials.gov registry entry for NCT06121297 describes a study currently listed as recruiting. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 28 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Cabaletta Bio, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 2 conditions, with Systemic Lupus Erythematosus appearing as the primary indexed condition, and to 1 intervention — of which CABA-201 is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06121297 reports 20 study locations spanning 12 distinct geographic areas — top geographies include Massachusetts, California, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT06121297 about?

NCT06121297 is a clinical study titled "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". 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

What is the current status of trial NCT06121297?

This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 28 participants. The study started on 2024-02-16. Estimated completion is 2029-12.

What conditions does trial NCT06121297 study?

This clinical trial studies the following conditions: Systemic Lupus Erythematosus, Lupus Nephritis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06121297?

The interventions under investigation include: CABA-201 (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06121297?

This trial is sponsored by Cabaletta Bio, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT06121297 being conducted?

This trial has 20 study locations across California, Connecticut, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial