Engineered Dendritic Cell Vaccines for Multiple Myeloma

April 21, 2026 updated by: Shenzhen Geno-Immune Medical Institute

Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

This trial protocol will inject DCvacs to MM or plasmacytoma patients who have been treated with a combination of anti-cancer regimens, including CAR-T cell therapy, and who have achieved partial or complete disease remission. The DCvacs are patient's own DCs which are immune modified to present target antigens and to activate anti-cancer immunity. The aim of this study is to evaluate the feasibility, safety, and efficacy of the innovative MM patient-based DC vaccines.

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Lung-Ji Chang, Ph.D
  • Phone Number: 86-0755-86725195
  • Email: c@szgimi.org

Study Locations

  • China
    • Guangdong
      • Shenzhen, Guangdong, China, 518000
        • Recruiting
        • Shenzhen Geno-immune Medical Institute
        • Contact:
          • Lung-Ji Chang, Ph.D
          • Phone Number: 86-0755-86725195
          • Email: c@szgimi.org
  • Russia
      • Vladivostok, Russia, 690105
        • Recruiting
        • The Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DCvac cells to treat MM
Biological: DC vaccines
Antigen-presenting and immune modifying DCvacs to treat MM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety of DC injection
Time Frame: 1 Month
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 Month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical response
Time Frame: 1 year
Anti-tumor activity of the DCvacs by examination of anti-cancer immunity by measurement of tumor burden
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Geno-Immune Medical Institute

Collaborators

The No.2 Clinical Hospital of the Ministry of Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2024

Primary Completion (Estimated)

July 11, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 14, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 21, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GIMI-IRB-24002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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