ClinicalTrials.gg
RecruitingNCT07085104RESOLUTIONUpdated Nov 2, 2026

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 interventional study of ALLO-329 and Cyclophosphamide in Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy and Systemic Sclerosis, sponsored by Allogene Therapeutics. Recruiting at 18 sites in 2 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-11-02.

Sponsored by Allogene Therapeutics · Phase 1, Interventional, and Treatment

From the registry’s dates

  • Started Nov 2025; still recruiting 11 months later.
Updated Nov 2, 20261 site addedGo to Updates ↓
Phase
Phase 1
Study type
Interventional
Enrollment
66
Allocation
Non-randomized
Ages
18 Years to 74 Years
Sex
All
01

Study summary

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).

02

Conditions studied

  • Systemic Lupus Erythematosus (With and Without Nephritis)
  • Idiopathic Inflammatory Myopathy
  • Systemic Sclerosis

Keywords

  • Systemic lupus erythematosus
  • SLE
  • Lupus nephritis
  • LN
  • Idiopathic inflammatory myopathy
  • IIM
  • Myositis
  • Dermatomyositis
  • Anti-synthetase syndrome
  • Systemic sclerosis
  • Scleroderma
  • SSc
  • Autoimmune disease
  • CAR T
  • Allogeneic CAR T
  • CD19
  • CD70
  • AlloCAR T
03

In context

Lupus Erythematosus, Systemic

1,207 studies on the registry are indexed under Lupus Erythematosus, Systemic; 405 are open to participants now.

This study's planned enrollment of 66 is above the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

Allogene Therapeutics is the lead sponsor of 9 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 74 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 ) negative at screening. All participants of childbearing potential must be willing to use a highly effective method of 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 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 agent for at least 3 months.

Exclusion criteria

Exclusion Criteria:

  1. Participants with active systemic bacterial, fungal, or viral infection requiring systemic treatment or a active, opportunistic, chronic or recurrent infection.
  2. Any active 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 abnormality requiring medical intervention.
  6. 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 to 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 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.
Terms in these criteria, in plain language(10)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

ECG (electrocardiogram)

A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.

Child-Pugh class

A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.

Relapsed and refractory

Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.

Platelets

Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.

05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
66 participants (estimated)

Study arms

  • Experimental
    ALLO-329, Cyclophosphamide

    Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.

    Genetic: ALLO-329 · Drug: Cyclophosphamide

  • Experimental
    ALLO-329

    Participants receive ALLO-329 without a lymphodepletion regimen.

    Genetic: ALLO-329

  • Experimental
    ALLO-329, Cyclophosphamide, Fludarabine

    Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine.

    Genetic: ALLO-329 · Drug: Cyclophosphamide · Drug: Fludarabine

Interventions

  • GeneticALLO-329

    An allogeneic CAR T cell therapy targeting CD19 and CD70

  • Chemotherapy for lymphodepletion

  • Chemotherapy for lymphodepletion

06

What researchers measure

Primary outcomes

  1. Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters

    The incidence of dose limiting toxicities (DLTs) and other safety parameters (including but not limited to treatment emergent adverse events \[AEs\], serious adverse events \[SAEs\], and clinical laboratory abnormalities)

    Time frame: Up to 60 months

Secondary outcomes

  1. Disease Response to Treatment - Systemic Lupus Erythematosus

    Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.

    Time frame: Up to 60 months

  2. Disease Response to Treatment - Systemic Lupus Erythematosus

    Efficacy as assessed by change from baseline in SLEDAI-2K score.

    Time frame: Up to 60 months

  3. Disease Response to Treatment - Lupus Nephritis

    Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).

    Time frame: Up to 60 months

  4. Disease Response to Treatment - Idiopathic Inflammatory Myopathy

    Efficacy as assessed by ACR/EULAR myositis response criteria components.

    Time frame: Up to 60 months

  5. Disease Response to Treatment - Systemic Sclerosis

    Efficacy as assessed by change from baseline in the European Scleroderma Trials and Research Group (EUSTAR) activity index.

    Time frame: Up to 60 months

  6. Disease Response to Treatment - Systemic Sclerosis

    Efficacy as assessed by change from baseline in the American College of Rheumatology Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS).

    Time frame: Up to 60 months

  7. ALLO-329 Peak Expansion (Cmax)

    Time frame: Up to 60 months

  8. ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC)

    Time frame: Up to 60 months

07

Study locations

17 of 18 sites recruiting
  • Mayo Clinic
    Phoenix, Arizona 85054, United States
    Recruiting
    • Vivek Nagaraja, MD · Principal investigator
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
    Recruiting
    • Hisham Abdel-Azim, MD · Principal investigator
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
    Recruiting
    • Melissa Griffith, MD · Principal investigator
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    Recruiting
    • Vikas Majithia, MD · Principal investigator
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    Recruiting
    • Michael Macklin, MD · Principal investigator
  • University of Iowa
    Iowa City, Iowa 52242, United States
    Recruiting
    • Hanna Zembrzuska, MD · Principal investigator
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    Recruiting
    • Paul Schmidt, MD · Principal investigator
  • Norton Cancer Institute, St. Matthews Campus
    Louisville, Kentucky 40207, United States
    Recruiting
    • Don Stevens, MD · Principal investigator
  • Johns Hopkins Hospital
    Baltimore, Maryland 21224, United States
    Recruiting
    • Maximillian Konig, MD · Principal investigator
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
    Recruiting
    • Birju Bhatt, MD · Principal investigator
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
    • Margrit Wiesendanger, MD · Principal investigator
  • New York Medical College
    Valhalla, New York 10595, United States
    Active, not recruiting

    Not enrolling at this site.

  • Atrium Health Rheumatology-Southpark
    Charlotte, North Carolina 28211, United States
    Recruiting
    • Leslie Ranken, MD · Principal investigator
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    Recruiting
    • Lisa Criscione-Schreiber, MD · Principal investigator
  • Medical University of South Carolina
    Charleston, South Carolina 29605, United States
    Recruiting
    • Melissa Cunningham, MD · Principal investigator
  • Prisma Health
    Greenville, South Carolina 29425, United States
    Recruiting
    • Cory McGee, MD · Principal investigator
  • LDS Hospital - lntermountain Health
    Salt Lake City, Utah 84143, United States
    Recruiting
    • Pankhuri Gupta, MD · Principal investigator
  • Hôpital Maisonneuve Rosemont
    Montreal, Quebec H1T 2M4, Canada
    Recruiting
    • Nicolas Richard, MD · Principal investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Sites
1 site added
Show site
  • New York Medical College · Valhalla, United States
Nov 2, 2026
Show all 1 update
  1. Nov 2, 2026
    1 site added
    Show site
    • New York Medical College · Valhalla, United States
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07085104
Lead sponsor
Allogene Therapeutics
Responsible party
Sponsor
First posted
Jul 25, 2025
Start date
Nov 13, 2025
Primary completion
Feb 2028 (estimated)
Completion
Oct 2032 (estimated)
Last update
Nov 2, 2026

Study contacts

Allogene Therapeutics, Inc.
Contact
clinicaltrials@allogene.com
+1 415-604-5696
Allogene Study Director
study director · Allogene Therapeutics, Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drugs tested here: Cyclophosphamide · Fludarabine

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