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)
Not yet recruiting
- Charlottesville
- Cleveland
- Evanston
- Great Neck
- Irvine
- La Jolla
- Paramus
- Pittsburgh
- Portland
- Saint Louis
- Tampa
NCT07008378 GN45773
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).
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
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
For the latest version of this information please go to www.forpatients.roche.com