A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD… (NCT07008378) | Clinical Trial Compass
Active — Not RecruitingPhase 1
A Study to Evaluate the Safety, Tolerability, Cellular Kinetics, and Pharmacodynamics of P-CD19CD20-ALLO1 in Participants With Multiple Sclerosis
United States60 participantsStarted 2025-10-15
Plain-language 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).
Who can participate
Age range18 Years – 60 Years
SexALL
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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 …
What they're measuring
1
Number of Participants With Dose-limiting Toxicity (DLTs) at Each Dose Level of P-CD19CD20-ALLO1