RecruitingPhase 1NCT07008378

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


Sponsor

Genentech, Inc.

Enrollment

60 participants

Start Date

Oct 15, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new CAR-T cell therapy called P-CD19CD20-ALLO1 for people with multiple sclerosis (MS). CAR-T therapy reprograms immune cells to eliminate certain B-cells that are thought to drive MS. This is an early-phase safety study in both progressive and relapsing forms of MS. **You may be eligible if...** - You are between 18 and 60 years old - You have progressive MS with a disability score between 3 and 6, and have shown disability worsening without relapses for the past 2 years - OR you have relapsing MS with active relapses and MRI changes in the past 2 years while on treatment, with a disability score between 0 and 6 **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have or are suspected to have a rare brain infection called PML - You have a known or suspected history of hemophagocytic lymphohistiocytosis (HLH) or neurotoxicity from prior therapies - You have another neurological condition that could mimic MS - You have a history of immune deficiency, serious infections, or prior CAR-T therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALP-CD19CD20-ALLO1 Cells

P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.

DRUGCyclophosphamide

Cyclophosphamide will be administered intravenously.

DRUGFludarabine

Fludarabine will be administered intravenously.


Locations(1)

Washington University School of Medicine

St Louis, Missouri, United States

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NCT07008378


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