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Engineered immune cells take on autoimmune diseases in first human trial

NCT ID NCT07085104

Disease control Sponsor: Allogene 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 31, 2026 · Updated 2 times

Summary

This early-stage study tests a new treatment called ALLO-329 for people with lupus, myositis, or scleroderma. The therapy uses specially engineered immune cells from a donor to target and calm the overactive immune system. The main goals are to check safety and see if it can improve disease symptoms.

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 66 people

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

Started

Nov 2025

Expected to finish

Oct 2032

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 74 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. Adults ≥ 18 to \< 75 years of age. 2. Adequate hematological function and liver, cardiac, and pulmonary function. 3. A highly sensitive urine pregnancy test or serum pregnancy test (for females of childbearing potential) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of contraception for at least 12 months for females (6 months for males) after LD chemotherapy or ALLO-329 administration, whichever is later. 4. Signed and dated informed consent form. 5. Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures. 6. Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing. 7. Disease activity as above despite prior treatment with standard of care therapy including at least one immunosuppressive agent for at least 3 months. Exclusion Criteria: 1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection. 2. Any active malignancy within 5 years prior to enrollment, except for adequately treated localized basal cell or squamous cell skin cancer, carcinoma in situ or low risk prostate cancer (Gleason score ≤ 6) under observation. Prior treatment of cancer with curative intent which in the opinion of the treating oncologist has less than a 10% chance of recurrence in the next 10 years can be allowed after discussion with the sponsor. 3. Prior treatment with CD19 or CD70 targeted therapy or any prior engineered cell therapy (e.g., CAR T therapy), except prior treatment with ALLO-329 in this study. 4. Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes). 5. Symptomatic cardiac or vascular disease requiring medical intervention within 6 months prior to screening, hemodynamically symptomatic pericardial effusion, or symptomatic electrocardiogram abnormality requiring medical intervention. 6. Child-Pugh Class B or C cirrhosis. 7. Symptomatic airway disease requiring medical intervention, pleural effusion ≥ Grade 2, or history of pulmonary embolism requiring anticoagulant therapy within 6 months of ALLO-329 dosing. 8. Participants known to be refractory to platelet or red blood cell transfusions or who will refuse indicated transfusion support to manage cell counts following treatment. 9. Any form of primary, inherited immunodeficiency. 10. Unwilling to participate in an extended safety monitoring period. 11. For participants with SLE: History or active disease involving CNS within the last 6 months or SLE that is drug-induced. For those with lupus nephritis, history of dialysis within 12 months prior to signing the informed consent form or expected need for renal replacement therapy within the next 12 months after dosing, or National Institutes of Health (NIH) chronicity score of 3+ in any of the following domains: glomerular sclerosis, glomerular fibrous crescents, tubular atrophy, and/or interstitial fibrosis. 12. Participants with IIM: A myositis other than specified classification per exclusion criteria, non-reversible, unrelated or weakness not amenable to assessment, or dermatomyositis with presence of anti-TIF1 gamma antibody. 13. Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.

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Conditions

The condition(s) this trial relates to.

autoimmune disease dermatomyositis diffuse scleroderma idiopathic inflammatory myopathy lupus nephritis myositis disease systemic lupus erythematosus systemic sclerosis

As listed by the trial registrant

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

Idiopathic inflammatory myopathy Systemic lupus erythematosus (with and without nephritis) Systemic sclerosis

How to take part

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

  1. The study's own enquiry address

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

  2. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Astera Cancer Care

    RECRUITING

    East Brunswick, New Jersey, 08816, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Hôpital Maisonneuve Rosemont

    RECRUITING

    Montreal, Quebec, H1T 2M4, Canada

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

  • LDS Hospital - lntermountain Health

    RECRUITING

    Salt Lake City, Utah, 84143, United States

  • Loma Linda University Medical Center

    RECRUITING

    Loma Linda, California, 92354, United States

  • Mayo Clinic

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Medical University of South Carolina

    RECRUITING

    Charleston, South Carolina, 29605, United States

  • Norton Cancer Institute, St. Matthews Campus

    RECRUITING

    Louisville, Kentucky, 40207, United States

  • Prisma Health

    RECRUITING

    Greenville, South Carolina, 29425, United States

  • The University of Chicago Medical Center

    RECRUITING

    Chicago, Illinois, 60637, United States

  • University of Colorado Denver

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Iowa

    RECRUITING

    Iowa City, Iowa, 52242, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

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