Description:
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.
Title
- Brief Title: 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
Clinical Trial IDs
- ORG STUDY ID:
13-009
- NCT ID:
NCT01995708
Conditions
Interventions
Drug | Synonyms | Arms |
---|
CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs) | | Arm 1 Vaccine |
Purpose
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.
Trial Arms
Name | Type | Description | Interventions |
---|
Arm 1 Vaccine | Experimental | This is a prospective, two-arm phase I randomized trial. Patients will be accrued only from and treated at MSKCCand The Rockefeller University/Center for Clinical & Translational Science . The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Twenty patients will accrue to the study and ten will receive vaccines at 9x10^6 LCs per dose (i.e., combination of 3x10^6 CT7 mRNA-electroporated LCs + 3x10^6 MAGE-A3 mRNA-electroporated LCs + 3x10^6 WT1 mRNA-electroporated LCs) and another ten who will not receive any LC vaccines but will otherwise undergo identical cytoreduction, ASCT, and standard supportive care. At approximately 3 months after ASCT and as deemed clinically appropriate, patients will start lenalidomide maintenance therapy, which is now standard to delay disease progression. | - CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
|
Arm 2 control | Active Comparator | Patients receive standard of care treatment after autologous stem cell transplant | |
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.
Maximum Eligible Age: | N/A |
Minimum Eligible Age: | 18 Years |
Eligible Gender: | All |
Healthy Volunteers: | No |
Primary Outcome Measures
Measure: | safety |
Time Frame: | 1 year |
Safety Issue: | |
Description: | The safety of the vaccine will be monitored and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 for toxicity and adverse event reporting to the Food and Drug Administration. Dose limiting toxicity (DLT) is defined as grade 3 or higher toxicity.The only toxicities captured outside of the SAEs reported will be all grade 1-5 toxicites deemed definitely, probably, or possibly related to the vaccine portion of the study. |
Secondary Outcome Measures
Measure: | Immune response monitoring |
Time Frame: | 1 year |
Safety Issue: | |
Description: | The secondary goal of the study is to monitor and compare changes in T cell responses (e.g., intracellular cytokine secretion assays, CTL responses, and immune reconstitution analyses) stimulated by the CT7, MAGE-A3, and WT1 mRNA-electroporated LCs relative to pre-vaccine baselines. |
Details
Phase: | Phase 1 |
Primary Purpose: | Interventional |
Overall Status: | Active, not recruiting |
Lead Sponsor: | Memorial Sloan Kettering Cancer Center |
Trial Keywords
- CT7
- MAGE-A3
- WT1 mRNA-electroporated Autologous Langerhans
- vaccine
- Autologous Stem Cell Transplantation
- 13-009
Last Updated
December 2, 2020