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Engineered immune cells take on stubborn arthritis in early trial

NCT ID NCT07100873

Disease control Sponsor: Adicet Therapeutics Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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 Results may not be published yet.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
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This status has not been confirmed recently, so it may be out of date.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 early-phase study tests a new treatment called ADI-001 for adults with rheumatoid arthritis that hasn't improved with standard therapies. ADI-001 uses specially engineered immune cells from a donor to target and destroy faulty immune cells that drive inflammation. The main goal is to check safety and find the right dose, with 25 participants receiving the therapy and being monitored for side effects.

Why investors are watching

Adicet Bio is testing ADI-001, a cell therapy made from donor immune cells, in people with severe rheumatoid arthritis that did not respond to other treatments. This small phase 1 trial compares two different pre-treatment regimens before the cell infusion, and the result matters because ADI-001 is the company's lead product. For a micro-cap company, this early data will shape whether investors see a viable path forward for its pipeline.

If it works: A positive result could show that ADI-001 is safe and reduces disease activity in a hard-to-treat group, which would support moving the drug into larger trials. That progress could strengthen the company's position as a developer of cell therapies beyond cancer.

If it fails: Phase 1 trials often fail to show enough benefit or reveal safety problems, and a poor result could set the program back or force the company to rethink its approach. Any delay in enrollment or data readout would also weigh on a company of this size, since it has few other products to fall back on.

AI-written from the trial record. Speculative, and not investment advice.

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 25 people

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

Started

Oct 2025

Expected to finish

Mar 2028

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 80 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: 1. ≥ 18 years of age. 2. Fulfills the 2010 ACR-EULAR RA classification criteria 3. Agreement not to take traditional medicines and medications not prescribed by a doctor 4. Adequate hematological, liver, cardiac and pulmonary function Exclusion Criteria: 1. Presence of severe liver disease, Child-Pugh class B or C. 2. Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent). 3. Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol) 4. History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.

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Conditions

The condition(s) this trial relates to.

rheumatoid arthritis

As listed by the trial registrant

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

Rheumatoid arthritis (RA

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  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

    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

Locations

  • Adicet Clinical Trials

    RECRUITING

    Shanghai, Shanghai Municipality, China

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