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One-Time CAR-T infusion tested against progressive MS

NCT ID NCT07825389

Disease control Sponsor: AbelZeta Inc. Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 Sep 17, 2026 · Last updated Sep 18, 2026 · Updated 1 time

Summary

Researchers are testing a one-time CAR-T cell therapy called C-CAR168 in adults with progressive multiple sclerosis that has not responded to standard treatments. The therapy uses a patient's own immune cells, engineered to target two proteins, and is given as a single intravenous infusion after chemotherapy. The trial aims to see whether the treatment is safe and whether it can slow disability progression over a year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
an experimental CAR-T cell therapy called C-CAR168, made from a patient's own immune cells and given as a single infusion
What this could lead to
If it works, this could offer a one-time treatment that slows or stops disability progression in people whose multiple sclerosis has resisted standard drugs.
What could go wrong
This is an early-phase trial with 119 participants, so safety and benefit are still unproven. CAR-T therapy carries risks of serious immune reactions and infections, and the treatment may not help everyone.

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.

Participants

About 119 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Feb 2027

An estimate. Start dates often move.

Expected to finish

Feb 2030

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 55 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.

Key Inclusion Criteria: * Able to sign and date the informed consent form. * Male or female, 18-55 years of age, body weight \>=40 kg. * Diagnosis of MS according to the 2024 McDonald criteria with cohort-specific progressive MS requirements. * Cohort 1: active SPMS; Cohort 2: PPMS or non-active SPMS. * Inadequate response to at least one prior high-efficacy disease-modifying therapy administered for at least 6 months. * Documented disability progression over the prior 24 months. * EDSS 3.0 to 6.5, inclusive. * Meets protocol-defined disease-duration, CSF, organ-function, cardiac/pulmonary, pregnancy testing, contraception, vaccination, and cellular-therapy follow-up requirements. Key Exclusion Criteria * RRMS, clinically isolated syndrome, radiologically isolated syndrome, or another diagnosis better explaining the neurologic course. * Alternative inflammatory demyelinating disorders, including AQP4-antibody-positive NMOSD and MOG-antibody-associated disease. * Active or chronic infection requiring antibiotics, or protocol-specified positive infectious disease testing. * Inadequate washout from prior MS therapy or specified recent immunomodulatory treatments. * Prior CAR T-cell therapy, other genetically modified immune cell therapy, or gene therapy. * Pregnant or breastfeeding, or planning pregnancy during the protocol-defined follow-up period. * Specified major cardiovascular, neurologic, transplant, malignancy, bleeding/thromboembolic, allergy, or protocol-compliance exclusions.

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis primary progressive multiple sclerosis secondary progressive multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

How to take part

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  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

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