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MS trial withdrawn before it began: CAR T-Cell hope on hold

NCT ID NCT07006805

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled This study
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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 However, the trial was withdrawn before enrolling any participants, so no data was collected.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The trial was withdrawn before enrolling anyone, so no results exist.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

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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