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NCT06121297 · ClinicalTrials.gov registry record · 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

A Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Cabaletta Bio.

Recruiting
Registry status
Phase 1
Development phase
28
Enrollment target
20
Study locations

NCT06121297: Recruiting Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, sponsored by Cabaletta Bio.

NCT06121297 is a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis that is actively recruiting participants, run by Cabaletta Bio. The registered enrollment target is 28 participants, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT06121297, a Phase 1 study of Systemic Lupus Erythematosus and Lupus Nephritis, is actively recruiting participants, sponsored by Cabaletta Bio.

RECRUITING
Registry status
Phase 1
Development phase
28 participants
Enrollment target
20
Study locations

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
Cabaletta Bio

6 total trials

What NCT06121297 shows while recruiting

NCT06121297 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 380-participant average among 99 other Systemic Lupus Erythematosus trials with a reported enrollment target (93% lower).

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.

NCT06121297 names 20 study sites across 12 states, led by Massachusetts, California, Florida.

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.

What interventions are being tested in trial NCT06121297?

The interventions under investigation include: CABA-201 (BIOLOGICAL).

Who is sponsoring clinical trial NCT06121297?

This trial is sponsored by Cabaletta Bio, which has 6 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Systemic Lupus Erythematosus

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT06121297's enrollment target sits among peer trials

28 85th of 99 higher than 15 of 99 other Systemic Lupus Erythematosus trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Systemic Lupus Erythematosus trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT06121297, the US trial registry maintained by the National Library of Medicine. NCT06121297 (small enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.