Not Yet RecruitingPhase 1/2

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

12 participantsStarted 2026-06

Plain-language 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

Who can participate

Age range18 Years – 60 Years

SexALL

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Inclusion criteria

✓. Moderate degree of previously accumulated disability as measured by the Expanded Disability Status Scale (EDSS)
✓. Documentation of clinical relapse or a positive historical gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) scan prior to Screening
✓. Prior treatment with a high-efficacy therapy or prior treatment failure of oral therapies
✓. Moderate Disability as measured by EDSS
✓. Presence of abnormal function on protocol specified EDSS Functional Systems Scale
✓. Objective worsening of disease prior to Screening while on standard of care therapy

Exclusion criteria

✕. Any history of seizure disorder, even if well-controlled on antiepileptics
✕. History of progressive multifocal leukoencephalopathy
✕. Any prior or concurrent exposure to mitoxantrone, alemtuzumab, total lymphoid irradiation
✕. Cladribine within 1 year of Screening
✕. Any investigational agent within 4 weeks or 5 half-lives of Screening, whichever is longer
✕. Other pre-specified Disease-Modifying Therapies be discontinued by the time of pre-conditioning or earlier as described in the protocol

What they're measuring

Primary (Part A: Dose Escalation) incidence and severity of adverse events

Timeframe: Up to 28 days after CABA-201 infusion

Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201

Timeframe: Up to 28 days after CABA-201 infusion

Trial details

NCT IDNCT07006805

SponsorCabaletta Bio

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-09

Contact for this trial

Cabaletta Bio

267-759-3100 clinicaltrials@cabalettabio.com

View on ClinicalTrials.gov More Relapsing Multiple Sclerosis (RMS) trials