Clinical trial NCT01995708: CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Official title: A Phase I Trial of Vaccination With CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Multiple Myeloma
Keywords: CT7
MAGE-A3
WT1 mRNA-electroporated Autologous Langerhans
vaccine
Autologous Stem Cell Transplantation
13-009
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2013-11-26
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to see if the investigator can help the immune system to work against myeloma.

This study will see if a vaccine made with altered dendritic cells will make T cells work against tumor cells. The stem cells collected for the transplant will also be used to grow dendritic cells in the lab. The dendritic cells will carry the antigens. These cells then will be injected under the skin. The investigators will do lab studies before and after the vaccination to find out if the vaccine is working.


Eligibility criteria: Inclusion Criteria:

* Symptomatic multiple myeloma, ISS stages I-III, within 12 months of starting therapy.
* Completion of induction therapy with Very Good Partial Response (VGPR), or better, by International Myeloma Working Group (IMWG) criteria.
* Deemed eligible for ASCT by standard institutional criteria.
* Age ≥18 years.
* Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and/or bone marrow aspirate.

Exclusion Criteria:

* Prior autologous or allogeneic SCT.
* Previous immunization against CT7, MAGE-A3, other cancer-testis antigens, or WT1.
* Known immunodeficiency, HIV positivity, hepatitis B, or hepatitis C.
* History of autoimmune disease (e.g., rheumatoid arthritis, SLE), other than vitiligo, diabetes, or treated thyroiditis, which are allowed.
* History of severe allergic reactions to vaccines or unknown allergens.
* Participation in any other clinical trial involving another investigational agent within 4 weeks prior to first immunization.
* Lenalidomide-related toxicities before ASCT necessitating its discontinuation as part of treatment.

Primary outcomes:
measure: Number of Participants Evaluated for Vaccine Safety
timeFrame: 1 year
Secondary outcomes:
measure: Median Progression Free Survival
timeFrame: Up to 7 years
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: David Chung, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chung DJ, Sharma S, Rangesa M, DeWolf S, Elhanati Y, Perica K, Young JW. Langerhans dendritic cell vaccine bearing mRNA-encoded tumor antigens induces antimyeloma immunity after autotransplant. Blood Adv. 2022 Mar 8;6(5):1547-1558. doi: 10.1182/bloodadvances.2021005941.