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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 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2026-04-09

No results posted yet for this 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

Conditions

Interventions

BIOLOGICAL

CABA-201

Single intravenous infusion of CABA-201 at a single dose level following preconditioning with fludarabine and cyclophosphamide

BIOLOGICAL

CABA-201

Single intravenous infusion of CABA-201 at escalating dose levels without preconditioning

Sponsors & Collaborators

  • Cabaletta Bio

    lead INDUSTRY

Principal Investigators

  • Medical Director · Cabaletta Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-16
Primary Completion
2029-12-31
Completion
2029-12-31
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06121297 on ClinicalTrials.gov