Multiple SclerosisEarly Phase 1NCT07546110
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).
A Early Phase 1 study testing NK042 and ofatumumab in people with Multiple Sclerosis, run by The Affiliated Hospital of Xuzhou Medical University.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- NK042 and ofatumumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- May 2026to 30 Dec 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
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- 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
- Subjects with hepatitis B surface antigen (HBsAg) or anti-hepatitis B core antibody (HBcAb) at the screening visit or 12 weeks prior to the first study intervention. If the serological results are consistent with a resolved infection or vaccination, for example, the presence of HBsAb, it may not exclude potential subjects from the trial;
- Subjects tested positive for hepatitis C antibodies at the screening visit or within 12 weeks prior to initiation of study drug administration. Note: Only subjects with positive hepatitis C antibodies due to previous disease remission after a confirmed negative hepatitis C ribonucleic acid (RNA) test were enrolled;
- Use of immunomodulatory monoclonal antibodies or study drugs within 3 months or 5 half-lives prior to the Screening Period, whichever is higher;
- The subject is known to be allergic to any component of study drug or any other NK cell injection drug;
- Subjects who were positive for hepatitis B and C screening tests received live or attenuated vaccines within 6 weeks prior to baseline;
- Subjects had MRI contraindications of pacemaker implantation, metal implants in high-risk areas (e.g., prosthetic heart valves, aneurysms/vascular clips), metal substances in high-risk areas (e.g., shrapnel), a known history of gadolinium allergy, or claustrophobia that would prevent completion of all MRI scans as defined in the protocol.
- Note: Patients with contraindication to gadolinium may be included in the study, but gadolinium developer shall not be used for MRI scanning;
- Current or past medical history of primary immunodeficiency;
- Subjects who were pregnant or lactating, or who were scheduled to become pregnant with severe psychiatric disorders during the study or within 12 months after the last dose, and were not eligible for follow-up;
- Other circumstances that the investigator did not consider appropriate for participation in this study;
- Subjects currently on any of the following drugs/treatments: aminopyridine/davapyridine, fingolimod, cladribine, cilimod, ponesimod, ozanimod, alemtuzumab, mitoxantrone, ocrelizumab, natalizumab, or similar approved but different trade names for MS, and any unapproved treatment or regimen for MS. Any new DMT approved after July 2022 and marketed at any time during the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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).
Read the detailed description
The study will consist of a Screening Period of up to 4 weeks, a Treatment Period, and a 1-year Follow-up Period.
- Conditions
- Multiple Sclerosis
- Being tested
- NK042, ofatumumab
- Keywords
- Multiple Sclerosis, NK cell therapy, CD20 monoclonal antibody, Cell immunotherapy, Multiple sclerosis (MS)、NK cell therapy、CD20 monoclo、Cell immunotherapynal antibody、
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NK042Biological
NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells。
ofatumumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: NK042; Drug: ofatumumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 48 weeks after first dose of NK042.
Secondary outcomes (1)
Expanded Disability Status Scale (EDSS) Score
Change in Expanded Disability Status Scale (EDSS) score from baseline to Week 24。
Measured: Baseline to week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study startMay 2026 (estimated)
- Primary completion30 Dec 2027 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multiple SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Zhang, MD, Principal investigator, The Affiliated Hospital of Xuzhou Medical UniversityFudong Shi, MD, Principal investigator, The General Hospital of Tianjin Medical University/Beijing tiantan HospitalGuiyun Cui, MD, Principal investigator, The Affiliated Hospital of Xuzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07546110
- Sponsor's protocol ID
- NK042-MS-IIT-01
- Status last verified
- Feb 2026
- First submitted
- 24 Mar 2026
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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).
- ClinicalTrials.gov ID
- NCT07546110
- Acronym / sponsor ID
- NK042-MS-IIT-01
- 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、
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Study start
- May 2026 (estimated)
- Primary completion
- 30 Dec 2027 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
The study will consist of a Screening Period of up to 4 weeks, a Treatment Period, and a 1-year Follow-up Period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Combination Therapy Group | Experimental | Biological: NK042, Drug: ofatumumabAll 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NK042NK042 is an allogeneic, off-the-shelf cellular therapy derived from healthy donors and enriched with NKR+ NK cells。 | Biological | Combination Therapy Group |
| ofatumumabOfatumumab 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. | Drug | Combination Therapy Group |
Primary outcome
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 48 weeks after first dose of NK042.
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.
1 secondary outcome
Expanded Disability Status Scale (EDSS) Score
Time frame: Baseline to week 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Zhang, MD principal investigator
The Affiliated Hospital of Xuzhou Medical University
Fudong Shi, MD principal investigator
The General Hospital of Tianjin Medical University/Beijing tiantan Hospital
Guiyun Cui, MD principal investigator
The Affiliated Hospital of Xuzhou Medical University
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NK042 and ofatumumab in people with Multiple Sclerosis, run by The Affiliated Hospital of Xuzhou Medical University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Zhang, MD (+86 18052268193, zy20037416@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs) (time frame: Up to 48 weeks after first dose of NK042.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.