Clareo Health | A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Genentech, Inc.
With
Poseida Therapeutics, Inc., a member of the Roche Group
Age
18–60
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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
You may not be if
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.
