A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
NCT ID: NCT07008378
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
60 participants
INTERVENTIONAL
2025-10-15
2032-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Dose Escalation
Participants will receive a lymphodepleting chemotherapy regimen followed by a single infusion of P-CD19CD20-ALLO1. Dose escalation decisions will be made after participants are observed for a minimum of 28 days for toxicity.
P-CD19CD20-ALLO1 Cells
P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide
Cyclophosphamide will be administered intravenously.
Fludarabine
Fludarabine will be administered intravenously.
Interventions
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P-CD19CD20-ALLO1 Cells
P-CD19CD20-ALLO1 Cells will be administered intravenously as per the schedule specified in the protocol.
Cyclophosphamide
Cyclophosphamide will be administered intravenously.
Fludarabine
Fludarabine will be administered intravenously.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Poseida Therapeutics, Inc., a member of the Roche Group
UNKNOWN
Genentech, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Genentech, Inc.
Locations
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Washington University School of Medicine
St Louis, Missouri, United States
Countries
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Central Contacts
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Reference Study ID Number: GN45773 https://forpatients.roche.com/
Role: CONTACT
Other Identifiers
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GN45773
Identifier Type: -
Identifier Source: org_study_id
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