Can engineered immune cells tame autoimmune diseases?

NCT ID NCT07783269

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 24, 2026 · Last updated Aug 25, 2026 · Updated 1 time

Summary

This trial is testing an experimental therapy called CTA313, which uses engineered immune cells (CAR T cells) to potentially reset the immune system in people with active autoimmune diseases. The study will include adults aged 18 to 75 with systemic lupus erythematosus, progressive multiple sclerosis, or autoimmune encephalitis. Participants will receive a single infusion of CTA313 and be monitored for safety and effectiveness over 24 months, with long-term follow-up for up to 15 years.

What this could mean

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

Active substance
CTA313 UCAR T cell infusion (CAR T cells)
What this could lead to
If successful, this could lead to a new treatment option that resets the immune system in autoimmune diseases, potentially reducing or eliminating the need for lifelong medications.
What could go wrong
This is an early-phase trial, so safety and effectiveness are not yet established. CAR T cell therapy can cause serious side effects, and the results may not lead to a widely available treatment.

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

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 81 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Sep 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 75 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: * Male or female, ≥ 18 and ≤ 75 years of age * Adequate organ function * Diagnosed with one of the following in addition to meeting disease-specific criteria: 1. Refractory Systemic Lupus Erythematosus (SLE) defined as an inadequate response to at least two immunomodulatory agents and one biologic agent 2. Primary progressive multiple sclerosis (PPMS) or non-active secondary progressive multiple sclerosis (SPMS) 3. Autoimmune Encephalitis (AIE) Key Exclusion Criteria: * Coexisting autoimmune diseases that could interfere with the attribution of disease activity or pose an increased safety risk * Participants with the following cardiac conditions are excluded: 1. History of heart failure New York Heart Association (NYHA) class III or IV; 2. History of myocardial infarction, cardiovascular angioplasty or stenting, unstable angina, or other serious heart diseases within 12 months of enrollment. * History of severe central nervous system (CNS) disorders that could compromise the participant's ability to comply with protocol requirements or interfere with the accuracy of study assessments * Current or prior malignancy unless the malignancy was treated with curative intent and the subject has no known active malignant disease present for ≥ 5 years before enrollment * Primary immune deficiency * Presence of uncontrolled infections * History of untreated hepatitis C virus, or syphilis * History of HIV infection, or active or latent hepatitis B virus (HBV) infection. * Evidence of active Epstein-Barr virus (EBV), cytomegalovirus (CMV) or tuberculosis (TB) * History of prior CAR-T cell therapy or any other genetically modified immune cell therapy * Having received live/attenuated vaccine within 4 weeks prior to enrollment * Participants with a history of hypersensitivity to tacrolimus * Those who have participated in other interventional clinical trials within 30 days before enrollment * Participants who meet disease-specific exclusionary criteria as specified

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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.

How to take part

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  1. The study's own enquiry address

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  2. The official record

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Contacts and locations

Study contacts

  • Contact

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