NCT01995708 · REGISTRY CONDITION SEARCH

CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE1
Status at capture: COMPLETED
Registry last update: 2024-02-09

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of Participants Evaluated for Vaccine Safety

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outcome · POSTED

Median Progression Free Survival

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

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.
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
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.
intervention Names
Biological: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
label
Arm 1 Vaccine
type
EXPERIMENTAL
description
Patients receive standard of care treatment after autologous stem cell transplant
intervention Names
Other: Standard of care
label
Arm 2 control
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Arm 1 Vaccine
description
Patients receive CT7/MAGE-A3/WT1 mRNA-electroporated autologous Langerhans-type dendritic cells ID on days 12, 30, and 90 after autologous stem cell transplant. Patients on the vaccine arm of the study will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after ASCT followed by two boosters at days +30 and +90. Vaccines will be dosed at 9x10\^6 LCs per vaccine x 3.
name
CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
type
BIOLOGICAL
arm Group Labels
Arm 2 control
description
No vaccines
name
Standard of care
type
OTHER

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 28
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Participants will be evaluated for the safety of the vaccine, 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.
measure
Number of Participants Evaluated for Vaccine Safety
time Frame
1 year

secondary Outcomes

description
Median profression free survival.
measure
Median Progression Free Survival
time Frame
Up to 7 years

Full study description

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.

Source references

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.
pmid
35100339
type
DERIVED