clinical trial · NCT06984341
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Participants With Severe, Treatment-refractory Systemic Lupus Erythematosus (SLE)
Genentech, Inc.·phase1·not yet recruiting·n = 162
Systemic Lupus ErythematosusP-CD19CD20-ALLO1 CellsCyclophosphamideFludarabineRimiducid
brief summary
The purpose of this study is to evaluate the safety and tolerability of P-CD19CD20-ALLO1 in participants with highly active, severe, refractory SLE with or without lupus nephritis (LN). This study includes a dose-escalation stage followed by an expansion stage. It will also evaluate the cellular kinetics (CK), pharmacodynamics (PD), and efficacy of P-CD19CD20-ALLO1.
started
Jun 30, 2026
primary completion
Nov 1, 2033
completion
Nov 1, 2033
last updated
Apr 23, 2026
official title
A Phase I, Multicenter, Open-label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, Pharmacodynamics, and Efficacy of P-CD19CD20-ALLO1 in Patients With Severe, Treatment-refractory Systemic Lupus Erythematosus
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol