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RecruitingNCT07085104RESOLUTIONUpdated Sep 10, 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 17 sites in 2 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-10.

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

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

Who can participate

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

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

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.
04

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

  • DrugCyclophosphamide

    Chemotherapy for lymphodepletion

  • DrugFludarabine

    Chemotherapy for lymphodepletion

05

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

06

Study locations

17 of 17 sites recruiting
  • Mayo Clinic
    Phoenix, Arizona 85054, United States
    • Vivek Nagaraja, MD · Principal investigator
    Recruiting
  • Loma Linda University Medical Center
    Loma Linda, California 92354, United States
    • Hisham Abdel-Azim, MD · Principal investigator
    Recruiting
  • University of Colorado Denver
    Aurora, Colorado 80045, United States
    • Melissa Griffith, MD · Principal investigator
    Recruiting
  • Mayo Clinic
    Jacksonville, Florida 32224, United States
    • Vikas Majithia, MD · Principal investigator
    Recruiting
  • The University of Chicago Medical Center
    Chicago, Illinois 60637, United States
    • Michael Macklin, MD · Principal investigator
    Recruiting
  • University of Iowa
    Iowa City, Iowa 52242, United States
    • Hanna Zembrzuska, MD · Principal investigator
    Recruiting
  • University of Kansas Medical Center
    Kansas City, Kansas 66160, United States
    • Paul Schmidt, MD · Principal investigator
    Recruiting
  • Norton Cancer Institute, St. Matthews Campus
    Louisville, Kentucky 40207, United States
    • Don Stevens, MD · Principal investigator
    Recruiting
  • Johns Hopkins Hospital
    Baltimore, Maryland 21224, United States
    • Maximillian Konig, MD · Principal investigator
    Recruiting
  • Astera Cancer Care
    East Brunswick, New Jersey 08816, United States
    • Birju Bhatt, MD · Principal investigator
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    • Margrit Wiesendanger, MD · Principal investigator
    Recruiting
  • Atrium Health Rheumatology-Southpark
    Charlotte, North Carolina 28211, United States
    • Leslie Ranken, MD · Principal investigator
    Recruiting
  • Duke University Medical Center
    Durham, North Carolina 27710, United States
    • Lisa Criscione-Schreiber, MD · Principal investigator
    Recruiting
  • Medical University of South Carolina
    Charleston, South Carolina 29605, United States
    • Melissa Cunningham, MD · Principal investigator
    Recruiting
  • Prisma Health
    Greenville, South Carolina 29425, United States
    • Cory McGee, MD · Principal investigator
    Recruiting
  • LDS Hospital - lntermountain Health
    Salt Lake City, Utah 84143, United States
    • Pankhuri Gupta, MD · Principal investigator
    Recruiting
  • Hôpital Maisonneuve Rosemont
    Montreal, Quebec H1T 2M4, Canada
    • Nicolas Richard, MD · Principal investigator
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

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
Sep 10, 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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