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
Location: See location...
Intervention Type: Biological, Drug
Study Type: Interventional
Study Phase: Phase 1
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

• Age 18-60 years (inclusive) at the time of signing Informed Consent Form

• Diagnosis of progressive MS according to the revised McDonald 2017 criteria, and:

⁃ Expanded disability status scale (EDSS) score at screening, from 3 to 6 inclusive Evidence of disability progression and no relapses in the 2 years prior to screening

⁃ \- Diagnosis of relapsing MS according to the revised McDonald 2017 criteria, and: Evidence of clinical relapses and MRI activity within two years prior to screening while on a disease modifying therapy

• EDSS score at screening, from 0 to 6 inclusive

• No relapses within 45 days of screening

Locations
United States
Missouri
Washington University School of Medicine
RECRUITING
St Louis
Contact Information
Primary
Reference Study ID Number: GN45773 https://forpatients.roche.com/
global-roche-genentech-trials@gene.com
888-662-6728 (U.S.)
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2032-08-31
Participants
Target number of participants: 60
Treatments
Experimental: Dose Escalation
Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
Sponsors
Leads: Genentech, Inc.
Collaborators: Poseida Therapeutics, Inc., a member of the Roche Group

This content was sourced from clinicaltrials.gov

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