MS trial withdrawn before it began: CAR T-Cell hope on hold
NCT ID NCT07006805
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study aimed to test a new treatment called CABA-201, a CAR T-cell therapy made from a patient's own immune cells, for people with multiple sclerosis (MS). The goal was to see if it was safe and could control the disease by targeting and resetting the immune system. However, the trial was withdrawn before enrolling any participants, so no data was collected.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- CABA-201 (a type of CAR T-cell therapy made from the patient's own immune cells)
- What this could lead to
- If it worked, this could point toward a new way to control multiple sclerosis by resetting the immune system.
- What could go wrong
- The trial was withdrawn before enrolling anyone, so no results exist. CAR T-cell therapy carries risks like cytokine release syndrome and infections.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Expected to start
-
Jun 2026
An estimate. Start dates often move.
- Expected to finish
-
Oct 2029
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 60 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria The main inclusion criteria include the following: * Able to provide informed consent. * Age ≥18 and ≤60 years of age. * Diagnosis of MS per the revised 2017 McDonald criteria (Thompson et al, 2018). * For participants with relapsing forms of MS only (RMS Cohort): 1. Moderate degree of previously accumulated disability as measured by the Expanded Disability Status Scale (EDSS) 2. Documentation of clinical relapse or a positive historical gadolinium (Gd)-enhancing magnetic resonance imaging (MRI) scan prior to Screening 3. Prior treatment with a high-efficacy therapy or prior treatment failure of oral therapies * For participants with progressive forms of MS only (PMS cohort): 1. Moderate Disability as measured by EDSS 2. Presence of abnormal function on protocol specified EDSS Functional Systems Scale 3. Objective worsening of disease prior to Screening while on standard of care therapy * Clinical stability by vital signs assessment at the time of screening Exclusion Criteria The main exclusion criteria include the following: * History of fulminant MS * Clinically significant concomitant central nervous system pathologies which, in the Investigator's judgement, may confound the ability to interpret study results or complicate identification or evaluation of neurotoxicity, including but not limited to: 1. Any history of seizure disorder, even if well-controlled on antiepileptics 2. History of progressive multifocal leukoencephalopathy * Active, inflammatory autoimmune disorder other than MS requiring immunomodulatory therapies a. Positive human immunodeficiency virus (HIV), hepatitis C virus (HCV) antibody, or hepatitis B surface antigen test, or evidence of active or chronic tuberculosis (TB) at Screening or other chronic viral infections as described in the protocol * Use of the following therapies: 1. Any prior or concurrent exposure to mitoxantrone, alemtuzumab, total lymphoid irradiation 2. Cladribine within 1 year of Screening 3. Any investigational agent within 4 weeks or 5 half-lives of Screening, whichever is longer 4. Other pre-specified Disease-Modifying Therapies be discontinued by the time of pre-conditioning or earlier as described in the protocol * Known malignancy or a history of malignancy * Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, or concomitant neurological disease, including severe (requiring medical intervention) and uncontrolled infections * Chronic pulmonary disease * Impaired cardiac function or clinically significant cardiac disease * Prior engineered T cell therapy involving permanent gene modification * Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic stem cell transplant.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
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