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临床试验/NCT06435910
NCT06435910尚未招募1 期

Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients

Shenzhen Geno-Immune Medical Institute4 个研究点 分布在 3 个国家目标入组 10 人开始时间: 2027年6月30日最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
尚未招募
入组人数
10
试验地点
4
主要终点
Safety of DC injection

研究概览

简要总结

The purpose of this study is to determine the feasibility, safety, and efficacy of dendritic cell (DC) vaccines in the treatment of multiple myeloma (MM) or plasmacytoma based on immune-modified DC vaccines (DCvac). This approach is aimed to achieve prolonged maintenance of remission in multiple myeloma or plasmacytoma patients.

详细描述

Important Regulatory Notice:

This trial record is only for global academic information registration on ClinicalTrials.gov. Neither the sponsor Beijing Meikang Jimian Biotechnology Co., Ltd. nor collaborator Shenzhen Geno-Immune Medical Institute has obtained NMPA clinical trial approval or clinical technology filing permission to carry out interventional cell therapy trials in mainland China.

ClinicalTrials.gov registration alone does not represent legal approval by Chinese health and drug regulatory authorities.

Multiple myeloma (MM) is a plasma cell malignancy, characterized by the aberrant occupation of bone marrow with malignant plasma cells, and the destruction of bones together with the production of abnormal immunoglobulins. The clinical symptoms and signs can be manifested through various mechanisms. At present, the therapeutic drugs for MM include glucocorticoid, cytotoxic drugs, immunosuppressants, protease inhibitors, monoclonal antibodies and cell therapies including hematopoietic stem cell transplantation (HSCT). Among them, immunotherapy has been proven to be a revolutionary treatment with great potential of producing long term cure.

In the past decades, adoptively transferred T cells modified with chimeric antigen receptors (CARs) have demonstrated high effectiveness, and the CAR-T therapy has changed the treatment paradigm for many hematological malignancies. Currently, several antibody-based therapies and a few BCMA-based CAR-T cell therapies have been approved for MM treatment. However, in many MM patients, the disease may still relapse after extensive immunotherapies including auto- and allo-HSCT. We have previously reported a DC-based immune activation strategy against MM in a preclinical study. This study proposes to apply the individual patients' MM tumor antigen-based DCs as vaccines (DCvac) to booster anti-myeloma immunity, in order to prevent disease relapse. The MM patients who have achieved very good partial or complete remission will be treated with multiple DCvacs to achieve a prolonged remission without disease recurrence.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female subjects with multiple myeloma or plasmacytoma
  • Very good partial or complete remission (CR) after prior combination therapies.
  • Expected survival > 12 weeks
  • Adequate venous access for blood withdrawal or apheresis, and no other contraindications for blood withdrawal
  • Voluntary informed consent is given with willingness to continue follow up

排除标准

  • Pregnant or lactating women
  • Uncontrolled active infection
  • HIV or active hepatitis B or hepatitis C infection
  • Concurrent use of systemic steroids; the use of inhaled steroids is not exclusionary

研究组 & 干预措施

DCvac cells to treat MM

Experimental

干预措施: DC vaccines (Biological)

结局指标

主要结局

Safety of DC injection

时间窗: 1 Month

Number of participants with treatment-related adverse events as assessed by CTCAE v4.0

次要结局

  • Clinical response(1 year)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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