Multiple Sclerosis
Conditions
Brief 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).
Interventions
BIOLOGICALP-CD19CD20-ALLO1 Cells
P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
DRUGCyclophosphamide
Cyclophosphamide will be administered intravenously.
DRUGFludarabine
Fludarabine will be administered intravenously.
Sponsors
Genentech, Inc.
Poseida Therapeutics, Inc., a member of the Roche Group
Study design
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Number of Chimeric Antigen Receptor (CAR) Transgene Copies in Blood Assessed by Droplet Digital Polymerase Chain Reaction (ddPCR) | Up to 5 years |
| B-cell Levels in the Blood | Up to 5 years |
| Number of Participants With Anti-CAR T Antibodies | Up to 5 years |
Countries
United States
Contacts
STUDY_DIRECTORClinical Trials
Genentech, Inc.
Outcome results
None listed