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Active (not recruiting) Phase 1 NCT07008378

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

Phase 1 – testing safety in a small group of people
Conditions: Multiple Sclerosis

Sponsor: Genentech, Inc.

trial.available_in: БГ
Overview
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).
Who can participate
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
Interventions
P-CD19CD20-ALLO1 Cells
BIOLOGICAL
Cyclophosphamide
DRUG
Fludarabine
DRUG
Locations 5
United States (5)
UCI Sue & Bill Gross Stem Cell Research Center
Irvine , California
UCSD Altman Clinical and Translational Research Institute
La Jolla , California
Rutgers University- Robert Wood Johnson Medical School
New Brunswick , New Jersey
Multiple Sclerosis Comprehensive Care Center at Northwell Health
New York , New York
Washington University School of Medicine
St Louis , Missouri
Technical details
Status
Active (not recruiting)
Phase
Phase 1
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
15.10.2025
Completion date
31.08.2032
Registry ID
NCT07008378
Source
clinicaltrials.gov
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