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A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
Autoimmune Disorder Multiple Sclerosis (MS)
Basic Details
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 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
- 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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com