Clinical trial NCT07008378: A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Multiple Sclerosis
Lead sponsor: Genentech, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Poseida Therapeutics, Inc., a member of the Roche Group
First posted: 2025-06-06
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief 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 criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Pregnant or breastfeeding, or intention of becoming pregnant within the timeframe in which contraception is required
* Participants who have confirmed or suspected Progressive Multifocal Leukoencephalopathy (PML)
* Known or suspected history of Hemophagocytic Lymphohistiocytosis/ Macrophage Activation Syndrome (HLH/MAS) or neurotoxicity with prior therapies
* Known presence of other neurologic disorders that may mimic MS
* History of currently active primary or secondary (non-drug-related) immunodeficiency
* Significant or uncontrolled medical disease which would preclude patient participation
* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV Ig, or acute blood product transfusions
* History of recurrent serious infections or chronic infection
* Prior treatment with CAR T-cell therapy, gene-therapy product, total body irradiation, bone marrow transplantation, allograft organ transplant, or hematopoietic stem cell transplant at any point
* Any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
* Inability to complete an MRI scan

Primary outcomes:
measure: Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1
timeFrame: Day 1 up to Day 29
measure: Number of Participants With Adverse Events (AEs)
timeFrame: Up to 5 years
Secondary outcomes:
measure: Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR)
timeFrame: Up to 5 years
measure: B-cell Levels in the Blood
timeFrame: Up to 5 years
measure: Number of Participants With Anti-CAR T Antibodies
timeFrame: Up to 5 years
Other outcomes:
Locations:
city: Irvine
country: United States
facility: UC Irvine, Sue & Bill Gross Stem Cell Research Center
state: California
city: La Jolla
country: United States
facility: UC San Diego, Altman Clinical and Translational Research Institute
state: California
city: Tampa
country: United States
facility: University of South Florida
state: Florida
city: Evanston
country: United States
facility: Northwestern University, Northwestern Memorial Hospital
state: Illinois
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
city: Saint Louis
country: United States
facility: Washington University, John L. Trotter Multiple Sclerosis Clinic
state: Missouri
city: New Brunswick
country: United States
facility: Rutgers University, Robert Wood Johnson Medical School
state: New Jersey
city: Paramus
country: United States
facility: Hackensack Meridian Neuroscience Institute, Paramus Campus
state: New Jersey
city: Great Neck
country: United States
facility: Northwell Health, Comprehensive MS Center
state: New York
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center, Magee Women's Hospital
state: Pennsylvania
city: Charlottesville
country: United States
facility: University of Virginia
state: Virginia
Study officials:
affiliation: Genentech, Inc.
name: Clinical Trials
role: STUDY_DIRECTOR
References: