Engineered Dendritic Cell Vaccines for Multiple Myeloma
1 other identifier
interventional
10
2 countries
2
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started May 2024
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 11, 2024
CompletedFirst Submitted
Initial submission to the registry
May 14, 2024
CompletedFirst Posted
Study publicly available on registry
May 30, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 11, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2027
April 24, 2026
April 1, 2026
3.2 years
May 14, 2024
April 21, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of DC injection
Number of participants with treatment-related adverse events as assessed by CTCAE v4.0
1 Month
Secondary Outcomes (1)
Clinical response
1 year
Study Arms (1)
DCvac cells to treat MM
EXPERIMENTALInterventions
Antigen-presenting and immune modifying DCvacs to treat MM
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Pregnant or lactating women
- Uncontrolled active infection
- HIV or active hepatitis B or hepatitis C infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, 518000, China
The Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
Vladivostok, 690105, Russia
Related Publications (2)
Han S, Wang B, Cotter MJ, Yang LJ, Zucali J, Moreb JS, Chang LJ. Overcoming immune tolerance against multiple myeloma with lentiviral calnexin-engineered dendritic cells. Mol Ther. 2008 Feb;16(2):269-79. doi: 10.1038/sj.mt.6300369. Epub 2007 Dec 11.
PMID: 18071334BACKGROUNDAyed AO, Chang LJ, Moreb JS. Immunotherapy for multiple myeloma: Current status and future directions. Crit Rev Oncol Hematol. 2015 Dec;96(3):399-412. doi: 10.1016/j.critrevonc.2015.06.006. Epub 2015 Jun 28.
PMID: 26153389BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 14, 2024
First Posted
May 30, 2024
Study Start
May 11, 2024
Primary Completion (Estimated)
July 11, 2027
Study Completion (Estimated)
December 31, 2027
Last Updated
April 24, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share