A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Allogene Therapeutics
Study ID
NCT07085104
Phase
PHASE1
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - 69 Years
Healthy Volunteers
Not accepted

Interventions

  • ALLO-329 — GENETIC
    An allogeneic CAR T cell therapy targeting CD19 and CD70
  • Cyclophosphamide — DRUG
    Chemotherapy for lymphodepletion

Study Details

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).

Key Dates

Start date
Nov 13, 2025
Status verified
Apr 2026
Primary completion
Feb 29, 2028
Completion
Oct 31, 2032

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ALLO-329, Cyclophosphamide
    Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.
  • Experimental: ALLO-329
    Participants receive ALLO-329 without a lymphodepletion regimen.

Primary Outcome Measure

Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters [ Time Frame: Up to 60 months ]

Central Contacts

Locations (12)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054
Vivek Nagaraja, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado DenverAuroraColorado80045
Melissa Griffith, MD (PRINCIPAL_INVESTIGATOR)
Mayo ClinicJacksonvilleFlorida32224
Vikas Majithia, MD (PRINCIPAL_INVESTIGATOR)
The University of Chicago Medical CenterChicagoIllinois60637
Michael Macklin, MD (PRINCIPAL_INVESTIGATOR)
University of IowaIowa CityIowa52242
Hanna Zembrzuska, MD (PRINCIPAL_INVESTIGATOR)
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207
Don Stevens, MD (PRINCIPAL_INVESTIGATOR)
Astera Cancer CareEast BrunswickNew Jersey08816
Birju Bhatt, MD (PRINCIPAL_INVESTIGATOR)
Icahn School of Medicine at Mount SinaiNew YorkNew York10029
Margrit Wiesendanger, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Lisa Criscione-Schreiber, MD (PRINCIPAL_INVESTIGATOR)
Medical University of South CarolinaCharlestonSouth Carolina29605
Melissa Cunningham, MD (PRINCIPAL_INVESTIGATOR)
Prisma HealthGreenvilleSouth Carolina29425
Cory McGee, MD (PRINCIPAL_INVESTIGATOR)
LDS Hospital - lntermountain HealthSalt Lake CityUtah84143
Pankhuri Gupta, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic· Phoenix, AZUniversity of Colorado Denver· Aurora, COMayo Clinic· Jacksonville, FLThe University of Chicago Medical Center· Chicago, ILUniversity of Iowa· Iowa City, IANorton Cancer Institute, St. Matthews Campus· Louisville, KY

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