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).

Sponsor
The Affiliated Hospital of Xuzhou Medical University
Study ID
NCT07546110
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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).

Key Dates

First listed
Apr 22, 2026
Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Dec 30, 2027
Completion
Dec 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Combination Therapy Group
    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.

Primary Outcome Measure

Incidence of Adverse events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Up to 48 weeks after first dose of NK042. ]

Central Contacts

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