Overview

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)

Status:
NOT_YET_RECRUITING

Trial end date:
2033-11-01

Target enrollment:

Participant gender:

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.

Phase:

PHASE1

Details

Lead Sponsor:

Genentech, Inc.

Treatments:

Cyclophosphamide
fludarabine