Drugs / ALLO-329
last change May 2026 re-read 3 minutes ago

ALLO-329

Cell therapy

Developed for
idiopathic inflammatory myopathy · systemic lupus erythematosus · systemic sclerosis
Investigated by
Allogene Therapeutics

Trials 1

202620272028
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 1 NCT07085104 Nov 2025 → Feb 2028 expected idiopathic inflammatory myopathy, systemic lupus erythematosus, systemic sclerosis Allogene Therapeutics Recruiting No outcome recorded

News releases announcing trial results or a regulatory action · 5

DateIssuerRelease
2026-05-13 Allogene Therapeutics Results Allogene Therapeutics Reports First Quarter 2026 Financial Results and Business Update allogene.com ↗
Initial observations at these early low dose levels show signs of clinical activity and favorable tolerability.
2026-04-15 Allogene Therapeutics Results Allogene Therapeutics Announces Nature Communications Publication Highlighting Pre-Clinical Data for ALLO-329, a Next Generation Dual-Targeted CD19/CD70 Allogeneic CAR T for Autoimmune Diseases allogene.com ↗
2025-04-07 Allogene Therapeutics Regulatory Allogene Granted Three U.S. FDA Fast Track Designations (FTD) for ALLO-329, a Next-Generation Dual-Targeted CD19/CD70 Allogeneic CAR T, for the Treatment of Lupus, Myositis and Scleroderma allogene.com ↗
Allogene Therapeutics, Inc. (Nasdaq: ALLO), a clinical-stage biotechnology company pioneering the development of allogeneic CAR T (AlloCAR T ™ ) products for cancer and autoimmune disease, today announced that ALLO-329, an investigational dual-targeted CD19/CD70 allogeneic CAR T, has received three Fast Track Designations (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with: active refractory moderate-to-severe systemic lupus erythematous (SLE); active severe/refractory idiopathic inflammatory myopathy (IIM), specifically dermatomyositis, immune mediated necrotizing myopathy and anti-synthetase syndrome; and active refractory diffuse systemic sclerosis (SSc).
2025-01-28 Allogene Therapeutics Regulatory Allogene Therapeutics Secures U.S. FDA IND Clearance for ALLO-329, Advancing its Next-Generation Allogeneic CAR T into Autoimmune Diseases allogene.com ↗
2024-11-18 Allogene Therapeutics Results Allogene Therapeutics Presents Preclinical Data for ALLO-329, an Allogeneic CD19/CD70 Dual CAR T for the Treatment of Autoimmune Disease at the American College of Rheumatology (ACR) Convergence allogene.com ↗
ALLO-329 Induces Deep, Transient Depletion of CD19+ B Cells and CD70+ T Cells, and Reduction in IgG and IgM without Lymphodepletion in Humanized Murine Models

Evidence & citations 2 cited values

Every value below carries the sentence it was read from. 1 source stands behind the page.

FieldValueCited text
Known as ALLO-329 ClinicalTrials.gov intervention name — accepted as the source's own label NCT07085104 ↗
Modality Cell therapy “An allogeneic CAR T cell therapy targeting CD19 and CD70” NCT07085104 ↗