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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 · Status: NOT_YET_RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2026-04-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

NK042

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

DRUG

ofatumumab

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.

Sponsors & Collaborators

  • The Affiliated Hospital of Xuzhou Medical University

    lead OTHER

Principal Investigators

  • Yong Zhang, MD · The Affiliated Hospital of Xuzhou Medical University

  • Fudong Shi, MD · The General Hospital of Tianjin Medical University/Beijing tiantan Hospital

  • Guiyun Cui, MD · The Affiliated Hospital of Xuzhou Medical University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-31
Primary Completion
2027-12-30
Completion
2028-12-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07546110 on ClinicalTrials.gov