ClinicalTrials.gov record NCT07085104
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
This Phase 1, single-arm, open-label study evaluates ALLO-329, an allogeneic dual anti-CD19/anti-CD70 CAR T cell therapy, in adults with systemic lupus erythematosus (with and without nephritis), idiopathic inflammatory myopathy, or systemic sclerosis. The main goals are to evaluate safety and tolerability, collect initial evidence of biological activity and clinical response, and determine a recommended Phase 2 regimen. Participants receive ALLO-329 in sequential experimental arms — without lymphodepletion, with cyclophosphamide, or with cyclophosphamide plus fludarabine — and will be followed for safety and disease response measures. This is a first-in-human (first time tested in people) study, so potential risks and side effects are less well understood than in later-stage trials.
What it is studying. The study is testing the safety and tolerability of ALLO-329, looking for initial signs of biological activity and clinical response in the listed autoimmune diseases, and determining a recommended dosing/regimen for Phase 2.
What the researchers hope to learn. Scientific goals are to evaluate safety and tolerability of ALLO-329, obtain initial evidence of biological activity and clinical response across the included autoimmune diseases, measure ALLO-329 peak expansion and persistence, and identify a recommended Phase 2 regimen.
What this study is about
The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.
This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
Interventions being studied
Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.
- Drug
- Cyclophosphamide
- Fludarabine
- Genetic
- ALLO-329
Eligibility
The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.
Inclusion criteria
- Adults ≥ 18 to < 75 years of age.
- Adequate hematological function and liver, cardiac, and pulmonary function.
- 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.
- Signed and dated informed consent form.
- Willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other procedures.
- Confirmed active disease (SLE, IIM, or SSc) as defined by the appropriate classification criteria for each respective disease, clinical evidence, and/or laboratory testing.
- 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
- Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a clinically significant active, opportunistic, chronic or recurrent infection.
- 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.
- 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.
- Clinically significant or unstable or uncontrolled acute or chronic disease (e.g., hypothyroidism and diabetes).
- 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.
- Child-Pugh Class B or C cirrhosis.
- 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.
- 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.
- Any form of primary, inherited immunodeficiency.
- Unwilling to participate in an extended safety monitoring period.
- 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.
- 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.
- Participants with SSc: Pulmonary arterial hypertension requiring treatment, rapidly progressive or severe SSc gastrointestinal involvement, or prior scleroderma renal crisis.
Study description and what participation involves
The registry record has no detailed description beyond the summary above.
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AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.
Participants receive ALLO-329, an allogeneic CAR T cell product; depending on the study arm they may get a lymphodepletion regimen of cyclophosphamide, or cyclophosphamide plus fludarabine, or receive ALLO-329 without lymphodepletion. They will be monitored for safety, tolerability, and disease response with assessments and follow-up for up to 60 months. Monitoring includes checking for adverse events and laboratory abnormalities. The registry does not provide a detailed visit schedule or list of specific tests and procedures beyond those treatment regimens and the long-term safety and response assessments.
How the study is structured. This is a Phase 1, non-randomized, open-label interventional study with sequential experimental arms. All participants receive the investigational product ALLO-329; some arms include a lymphodepletion regimen (cyclophosphamide alone or cyclophosphamide plus fludarabine) and one arm receives ALLO-329 without lymphodepletion. Participants are monitored over time for safety (including dose-limiting toxicities), measures of disease response, and ALLO-329 expansion and persistence.
Questions you could ask
These questions are suggestions for a conversation with the study team or your own clinician, not advice.
- This is an early-phase study, mainly about safety and dose. What is already known about this treatment?
- The listed sites are in Canada, United States. Is any of them reachable for me, and does the study help with travel?
- Which of the eligibility criteria would need to be checked with tests before I could join?
More on dermatomyositis
This trial is also listed on this site under anti-synthetase syndrome and polymyositis.
Important dates
- Study start
- Nov 13, 2025
- Primary completion
- February 2028 (estimated)
- Study completion
- October 2032 (estimated)
- Target enrollment
- 66 participants (estimated)
- Last updated on registry
- Sep 10, 2026
- Data verified
- Oct 10, 2026
Sponsor and research team
The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.
- Lead sponsor
- Allogene Therapeutics
Central study contact
If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.
- Allogene Therapeutics, Inc. 📞 +1 415-604-5696 ✉ clinicaltrials@allogene.com
Participating sites (17)
- Mayo ClinicRecruiting
Phoenix, Arizona, 85054 · United States
- Vivek Nagaraja, MD
- Loma Linda University Medical CenterRecruiting
Loma Linda, California, 92354 · United States
- Hisham Abdel-Azim, MD
- University of Colorado DenverRecruiting
Aurora, Colorado, 80045 · United States
- Melissa Griffith, MD
- Mayo ClinicRecruiting
Jacksonville, Florida, 32224 · United States
- Vikas Majithia, MD
- The University of Chicago Medical CenterRecruiting
Chicago, Illinois, 60637 · United States
- Michael Macklin, MD
- University of IowaRecruiting
Iowa City, Iowa, 52242 · United States
- Hanna Zembrzuska, MD
- University of Kansas Medical CenterRecruiting
Kansas City, Kansas, 66160 · United States
- Paul Schmidt, MD
- Norton Cancer Institute, St. Matthews CampusRecruiting
Louisville, Kentucky, 40207 · United States
- Don Stevens, MD
- Johns Hopkins HospitalRecruiting
Baltimore, Maryland, 21224 · United States
- Maximillian Konig, MD
- Astera Cancer CareRecruiting
East Brunswick, New Jersey, 08816 · United States
- Birju Bhatt, MD
Terms used on this page · explanations by MedicalUpdates.ai
- first-in-human
- The first study in which a treatment is given to people. Safety is the main question and the number of participants is usually small.
- single-arm
- All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
- open-label
- No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.
- chimeric antigen receptor
- A treatment in which a person's own immune cells (T cells) are collected, modified in a laboratory to recognise a target, and returned to the body.
- Phase 2
- A study that tests whether a treatment has the intended effect and continues to check safety, usually in a larger group than phase 1.
- childbearing potential
- Studies often ask participants who could become pregnant, or could father a child, to use contraception during the study and for a period afterwards, because the effect of the treatment on a pregnancy is unknown.
- at screening
- The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
- informed consent form
- The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
- prior treatment
- Treatment a person has already had for the condition. A 'line of therapy' is one course of treatment; studies often require, or limit, the number of prior lines.
- standard of care
- Treatment generally considered appropriate for a condition in a particular clinical setting. It can vary by patient, place and over time. In many studies the new treatment is added to, or compared with, standard of care.
- immunosuppressive
- A medicine that reduces the activity of the immune system. Studies of autoimmune conditions often require a stable dose, a prior failure, or a washout of such medicines.
- enrollment
- The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
- sponsor
- The organisation or person that initiates the study and has authority over it. The sponsor may be a company, hospital, university, government agency or individual, and is not necessarily the organisation that funds the study.
- electrocardiogram
- A recording of the heart's electrical activity. QTc is one measurement from it; some drugs are avoided if it is prolonged.
- refractory
- A condition that has not responded to a treatment. 'Relapsed' means it responded and then came back; 'refractory' means it did not respond in the first place.
- exclusion criteria
- The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
- Inclusion Criteria
- The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.
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