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RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis

NCT07006805 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-10-31

No results posted yet for this study

Summary

RESET-MS: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T cells (CABA-201) in Participants with Multiple Sclerosis

Conditions

  • Relapsing Multiple Sclerosis (RMS)
  • Progressive Multiple Sclerosis (PMS)
  • Multiple Sclerosis - Relapsing Remitting
  • Multiple Sclerosis
  • Multiple Sclerosis (Relapsing Remitting)
  • Multiple Sclerosis (MS) - Relapsing-remitting
  • Progressive Multiple Sclerosis

Interventions

BIOLOGICAL

CABA-201

Single intravenous infusion of CABA-201 following preconditioning with fludarabine and cyclophosphamide

Sponsors & Collaborators

  • Cabaletta Bio

    lead INDUSTRY

Principal Investigators

  • Medical Monitor · Cabaletta Bio

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

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

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2028-09-30
Completion
2029-10-31
FDA Drug
Yes

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 NCT07006805 on ClinicalTrials.gov