NCT07008378

A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis

A Phase I, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Patients With Multiple Sclerosis

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Genentech, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

This study aims to explore the safety, tolerability, cellular kinetics, and pharmacodynamics of P-CD19CD20-ALLO1 in participants with progressive multiple sclerosis (PMS) and relapsing multiple sclerosis (RMS).

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
BIOLOGICAL	P-CD19CD20-ALLO1 Cells	P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
DRUG	Cyclophosphamide	Cyclophosphamide will be administered intravenously.
DRUG	Fludarabine	Fludarabine will be administered intravenously.

Timeline

• Start date: 2025-10-15
• Primary completion: 2032-08-31
• Completion: 2032-08-31
• First posted: 2025-06-06
• Last updated: 2026-01-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study