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).

NCT07546110 | Not Yet Recruiting Early Phase 1

• 1 other identifier: NK042-MS-IIT-01
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief 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).

Conditions

Multiple Sclerosis

Keywords

Multiple Sclerosis; NK cell therapy; CD20 monoclonal antibody; Cell immunotherapy; Multiple sclerosis (MS)、NK cell therapy、CD20 monoclo、Cell immunotherapynal antibody、

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)

  Number of subjects experiencing adverse events, and the frequency and severity of adverse events. The type, frequency, onset, and severity of treatment-emergent adverse events (TEAEs) will be assessed in accordance with the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE),version 5.0.

  Up to 48 weeks after first dose of NK042.

Secondary Outcomes (1)

• Expanded Disability Status Scale (EDSS) Score

  Baseline to week 24

Study Arms (1)

Combination Therapy Group

EXPERIMENTAL

All participants in this single-arm study will receive the combined intervention, which consists of a standard regimen of a CD20 monoclonal antibody administered concurrently with NK042 cell injection (an allogeneic natural killer cell therapy). The dose level of NK042 cells will be escalated sequentially across participant cohorts following safety assessment.

Biological: NK042; Drug: ofatumumab

Interventions

NK042 BIOLOGICAL

NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells。

Combination Therapy Group

ofatumumab DRUG

Ofatumumab is a fully human monoclonal antibody targeting the CD20 antigen on the surface of B lymphocytes. In this study, it will be administered in combination with the investigational NK042 cell injection.

Combination Therapy Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• 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;
• Subjects who were HIV-positive;
• Subjects with laboratory abnormalities at the screening visit:
• alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 3.0 × upper limit of normal (ULN)
• Bilirubin \> 1.5×ULN；; Unless the subject had a history of Gilbert syndrome (bilirubin \> 1.5×ULN acceptable if bilirubin was split in two and direct bilirubin \< 35%)
• serum albumin \< 3.5 g/dL
• Estimated glomerular filtration rate \< 60 mL/min/1.73 m2 (modified diet for patients with renal disease \[MDRD\])
• other abnormal laboratory values or electrocardiogram (ECG) changes considered clinically significant at the investigator's discretion

Sponsors & Collaborators

• The Affiliated Hospital of Xuzhou Medical University: lead

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ofatumumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Yong Zhang, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

• Fudong Shi, MD

  The General Hospital of Tianjin Medical University/Beijing tiantan Hospital

  PRINCIPAL INVESTIGATOR

• Guiyun Cui, MD

  The Affiliated Hospital of Xuzhou Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Zhang, MD

CONTACT

+86 18052268193; zy20037416@163.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2026
• First Posted: April 22, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share