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ALLO-329

Phase 1

Systemic Lupus Erythematosus (With and Without Nephritis) | Gene therapy | Immunology |Allogene Therapeutics, Inc.|Last Updated: Jun 18, 2026

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Trial Design
RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment66
FDA Designations
FAST_TRACK
Clinical trial landscape

ALLO-329 · 1 trial · 3 indications

Phase 1 1
NCT07085104A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune DiseaseSystemic Lupus Erythematosus (With and Without Nephritis)
RECRUITING66 Analytics
PHASE1RECRUITING
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis)Unlock trial analytics
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.
ALLO-329, Cyclophosphamide, FludarabineEXPERIMENTALParticipants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine.
Interventions
NameTypeDescription
ALLO-329GENETICAn allogeneic CAR T cell therapy targeting CD19 and CD70
CyclophosphamideDRUGChemotherapy for lymphodepletion
FludarabineDRUGChemotherapy for lymphodepletion
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Eligibility Criteria
Age Range18 Years to 69 Years
SexALL
Healthy VolunteersNo
Study Sites14

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)
MEDIUMJun 18, 2026NCT07085104lastUpdatePostDate: changed
MEDIUMJun 18, 2026NCT07085104lastUpdatePostDate: changed
MEDIUMJun 18, 2026NCT07085104lastUpdatePostDate: changed
MEDIUMMay 26, 2026NCT07085104Enrollment: 54 → 66
LOWMay 24, 2026NCT07085104studyFirstPostDate: changed