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Trial Title:
Engineered Dendritic Cell Vaccines for Multiple Myeloma
NCT ID:
NCT06435910
Condition:
Multiple Myeloma or Plasmacytoma
Conditions: Official terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Plasmacytoma
Conditions: Keywords:
MM
CAR T
DC vaccine
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
DC vaccines
Description:
Antigen-presenting and immune modifying DCvacs to treat MM
Arm group label:
DCvac cells to treat MM
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
80 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Shenzhen Geno-immune Medical Institute
Address:
City:
Shenzhen
Zip:
518000
Country:
China
Status:
Recruiting
Contact:
Last name:
Lung-Ji Chang, ph.D
Phone:
86-0755-86725195
Email:
c@szgimi.org
Facility:
Name:
The Regional Hematology Center in Clinical Hospital No. 2 of the Ministry of Health
Address:
City:
Vladivostok
Zip:
690105
Country:
Russian Federation
Status:
Recruiting
Contact:
Last name:
Vitaly Dubov, MD
Phone:
8(924)3321996
Email:
drvdubov@gmail.com
Start date:
May 11, 2024
Completion date:
December 31, 2027
Lead sponsor:
Agency:
Shenzhen Geno-Immune Medical Institute
Agency class:
Other
Collaborator:
Agency:
The No.2 Clinical Hospital of the Ministry of Health
Agency class:
Other
Source:
Shenzhen Geno-Immune Medical Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06435910
