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ALLO-329

Phase 1

Systemic Lupus Erythematosus (With and Without Nephritis) | Gene therapy | Immunology |Allogene Therapeutics, Inc.|Last Updated: Apr 7, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment66
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07085104A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune DiseasePHASE1 RECRUITING 66Nov 13, 2025Oct 1, 2032Apr 7, 202613 United States, Canada
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Study Endpoints
Primary Endpoints
Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters
Up to 60 months

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)

Secondary Endpoints
Disease Response to Treatment - Systemic Lupus Erythematosus
Up to 60 months
Disease Response to Treatment - Lupus Nephritis
Up to 60 months
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Up to 60 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
ALLO-329, CyclophosphamideEXPERIMENTALParticipants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.
ALLO-329EXPERIMENTALParticipants receive ALLO-329 without a lymphodepletion regimen.
Interventions
NameTypeDescription
ALLO-329GENETICAn allogeneic CAR T cell therapy targeting CD19 and CD70
CyclophosphamideDRUGChemotherapy for lymphodepletion
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Eligibility Criteria
Age Range18 Years — 69 Years
SexALL
Healthy VolunteersNo
Study Sites13

Inclusion Criteria: 1. Adults ≥ 18 to \< 70 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...

Countries:United StatesCanada
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Recent Changes (Last 90 Days)
MEDIUMMay 26, 2026NCT07085104Enrollment: 54 → 66
LOWMay 24, 2026NCT07085104studyFirstPostDate: changed