Can engineered immune cells tame autoimmune diseases?
NCT ID NCT07783269
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 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.
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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Autoimmune encephalitis are added.
By submitting, you agree to our Terms of use
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
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
By submitting, you agree to our Terms of use
Study contacts
-
Contact
Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can CRISPR-Edited cells stop autoimmune attacks on the brain?
- A new approach to protect young hearts from lupus complications
- Can a blood pressure pill slow MS disability?
- Can an Iron-Based dye reveal hidden inflammation in progressive MS?
- Could a simple injection replace an IV for MS treatment?
- Could a common supplement fight fatigue in progressive MS?