RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple S… (NCT07006805) | Clinical Trial Compass
WithdrawnPhase 1/2
RESET-MS: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Multiple Sclerosis
Stopped: The study was withdrawn prior to site activation and before enrollment of any participants due to sponsor decision to reprioritize the development portfolio.
0Started 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 range
18 Years – 60 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary (Part A: Dose Escalation) incidence and severity of adverse events
Timeframe: Up to 28 days after CABA-201 infusion
2
Primary (Part B: Dose Expansion) incidence of and severity of adverse events in order to confirm the dose(s) of CABA-201