Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435910
Status:
RECRUITING
Last Update Posted:
2024-06-10
First Post:
2024-05-14
Brief Title:
Engineered Dendritic Cell Vaccines for Multiple Myeloma
Sponsor:
Shenzhen Geno-Immune Medical Institute
Organization:
Shenzhen Geno-Immune Medical Institute
Study Overview
Official Title:
Engineered Dendritic Cell Vaccines for Remission Maintenance in Multiple Myeloma Patients
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients 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
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 patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None