P-CD19CD20-ALLO1 Cells: P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide: Cyclophosphamide will be administered intravenously.
Fludarabine: Fludarabine will be administered intravenously.
Study 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
Sex
ALL
Min age
18 Years
Max age
60 Years
Healthy volunteers
No
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 outcome measure(s)
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1 — Day 1 up to Day 29
Number of Participants With Adverse Events (AEs) — Up to 5 years
Trial sites (5)
Facility
City
Region
Status
UCI Sue & Bill Gross Stem Cell Research Center
Irvine
California
UCSD Altman Clinical and Translational Research Institute
La Jolla
California
Washington University School of Medicine
St Louis
Missouri
Rutgers University- Robert Wood Johnson Medical School
New Brunswick
New Jersey
Multiple Sclerosis Comprehensive Care Center at Northwell Health
New York
New York
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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