An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 … (NCT07546110) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
An Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined With NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).
20 participantsStarted 2026-05
Plain-language summary
This is an Open-Label, Single-Arm Clinical Study to Evaluate the Safety and Preliminary Efficacy of CD20 Monoclonal Antibody Combined with NK042 Cell Injection in the Treatment of Multiple Sclerosis (MS).
Who can participate
Age range18 Years – 65 Years
SexALL
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Inclusion criteria
✓. Able to understand research requirements, voluntary participation, and can provide written informed consent;
✓. Age ≥18 years and ≤65 years;
✓. Subjects diagnosed with relapsing-remitting multiple sclerosis (RRMS), secondary progressive multiple sclerosis (SPMS, with or without recurrence), or primary progressive multiple sclerosis (PPMS) according to the 2017 revision of McDonald's diagnostic criteria (SPMS diagnostic criteria include an initial relapsing-remitting course, subsequent disease progression with or without incidental relapse, mild remission, and plateau; Progress refers to the continuous deterioration of neurological impairment for at least 6 months);
✓. Subjects in the Screening phase had an EDSS score of ≥2.5 and ≤6.5.
✓. Subjects who weighed ≥ 45 kg and had a body mass index (BMI) of ≥ 18.0 kg/m2.
Exclusion criteria
✕. Subjects with a history of seizures or epilepsy (a history of febrile seizures in childhood was permitted);
✕. Subjects with known clinical relapses (acute or subacute new or exacerbating neurological dysfunction with subsequent complete or partial recovery without fever or infection) within 8 weeks prior to enrollment;
✕. Subjects with a history of neurological disorders other than MS, such as head trauma, cerebrovascular disease, and vascular dementia within 3 months;
✕. Recent history of severe infection (e.g., infectious pneumonia, sepsis) within 4 weeks prior to screening; Infections requiring hospitalization or intravenous antibiotics, antiviral drugs, or antifungal drugs within 4 weeks prior to screening; Or a subject with a chronic bacterial infection (e.g., tuberculosis) determined by the investigator to be unacceptable;
What they're measuring
1
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
Timeframe: Up to 48 weeks after first dose of NK042.
Trial details
NCT IDNCT07546110
SponsorThe Affiliated Hospital of Xuzhou Medical University
✕. Subjects with severe cognitive impairment, mental illness, other neurodegenerative disorders (such as Parkinson's disease or Alzheimer's disease), the presence of substance abuse or any other condition that would make a subject unsuitable for the study, or subjects the investigator believes may interfere with assessment or study completion;
✕. Subjects with a history of attempted suicide or Grade 4 or 5 suicidal ideation on the Columbia Suicide Severity Rating Scale (C-SSRS) within 24 weeks prior to the screening visit, or subjects at risk for suicide as determined by the investigator;
✕. Subjects with a history of unstable or severe heart, lung, tumor, liver, or kidney disease or other conditions of medical significance other than MS that prevented safe participation in the study;
✕. Subjects who received live vaccine within 14 days prior to the screening visit or were scheduled to receive vaccine during the study;