Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kin… (NCT06675864) | Clinical Trial Compass
RecruitingPhase 1/2
Open-label, Multi-center, Phase I/II Study to Assess Safety, Disease Progression and Cellular Kinetics Following YTB323 Administration in Participants With Non-active Progressive Multiple Sclerosis (PMS)
This is an open-label, multi-center, non-confirmatory study to assess the safety, disease progression, and cellular kinetics following YTB323 administration to 28 participants with non-active Progressive Multiple Sclerosis (PMS). The study design utilizes an ascending single dose design consisting of 3 sentinel cohorts followed by an expansion cohort.
Who can participate
Age range18 Years – 60 Years
SexALL
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Inclusion criteria
✓. Male or female participants 18 to 60 years (inclusive) at screening.
✓. Signed informed consent must be obtained prior to participation in the study.
✓. Able to communicate well with the investigator, to understand and comply with the requirements of the study including:
✓. Diagnosis of SPMS or PPMS according to the 2017 McDonald diagnostic criteria (Thompson et al 2018) as confirmed at screening visit.
✓. Less than 15 years (inclusive) from onset of first MS symptoms as determined by the investigator during screening.
✓. Ambulatory Patients (EDSS 3 to 6.5 inclusive) at screening.
✓. Evidence of recent (within 24 months) disease progression of ≥1.00 on the EDSS scale.
✓. No relapse in the last 24 months at screening.
Exclusion criteria
✕. Diagnosis of relapsing multiple sclerosis (RMS) or active PMS according to the 2017 revision of the McDonald diagnostic criteria (Thompson et al 2018) at screening.
✕. History of, or current, clinically significant CNS disease except MS (e.g. stroke, traumatic brain or spinal injury, history or presence of myelopathy, history of seizures or epilepsy) or neurological disorders which may mimic MS at screening.
✕. Evidence of clinically significant cardiovascular (such as but not limited to myocardial infarction, unstable ischemic heart disease, New York Heart Association Class III/IV left ventricular failure, arrhythmia and uncontrolled hypertension within 6 months prior to or during screening).
What they're measuring
1
Number of participants with dose limiting toxicities (DLTs), Adverse Events (AEs), and Serious Adverse Events (SAEs)
✕. Participants with history of confirmed Progressive Multifocal Leukoencephalopathy (PML) or neurological symptoms consistent with PML prior to or during screening.
✕. Clinically significant, active, opportunistic, chronic or recurrent infection (including positive for hepatitis B or hepatitis C) confirmed by clinical evidence, imaging, or positive laboratory tests one month prior to leukapheresis.
✕. Have donated blood or experienced a loss of blood \> 400 mL within 3 months prior screening, or longer if required by local regulations.
✕. Any prior stem cell therapy or organ transplantation or gene therapy.
✕. Any contraindications to LP, including but not limited to: