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History of Changes for Study: NCT01995708
CT7, MAGE-A3, and WT1 mRNA-electroporated Autologous Langerhans-type Dendritic Cells as Consolidation for Multiple Myeloma Patients Undergoing Autologous Stem Cell Transplantation
Latest version (submitted June 22, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 November 25, 2013 None (earliest Version on record)
2 December 23, 2013 Arms and Interventions, Study Design, Study Status and Eligibility
3 March 18, 2014 Study Status, Contacts/Locations, Eligibility and Arms and Interventions
4 April 28, 2014 Contacts/Locations, Study Status and Eligibility
5 June 17, 2014 Study Status and Eligibility
6 October 6, 2014 Study Status
7 April 15, 2015 Study Status, References and Contacts/Locations
8 September 10, 2015 Study Status and Outcome Measures
9 February 4, 2016 Study Status and Arms and Interventions
10 August 8, 2016 Study Status, Arms and Interventions and Conditions
11 September 20, 2016 Study Status
12 February 15, 2017 Study Status
13 July 5, 2017 Study Status
14 March 19, 2018 Study Status and Study Design
15 November 8, 2018 Study Status
16 December 3, 2018 Study Status
17 December 6, 2018 Recruitment Status, Contacts/Locations, Study Status, Study Design and Sponsor/Collaborators
18 December 6, 2019 Study Status
19 December 1, 2020 Study Status
20 December 1, 2021 Study Status
21 January 21, 2022 Study Status
22 June 22, 2022 Recruitment Status and Study Status
Comparison Format:

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Study NCT01995708
Submitted Date:  November 25, 2013 (v1)

Open or close this module Study Identification
Unique Protocol ID: 13-009
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
Secondary IDs:
Open or close this module Study Status
Record Verification: November 2013
Overall Status: Recruiting
Study Start: November 2013
Primary Completion: November 2014 [Anticipated]
Study Completion:
First Submitted: November 20, 2013
First Submitted that
Met QC Criteria:
November 25, 2013
First Posted: November 26, 2013 [Estimate]
Last Update Submitted that
Met QC Criteria:
November 25, 2013
Last Update Posted: November 26, 2013 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Memorial Sloan Kettering Cancer Center
Responsible Party: Sponsor
Collaborators: Rockefeller University
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring:
Open or close this module 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.

Detailed Description:
Open or close this module Conditions
Conditions: Multiple Myeloma
Keywords: CT7,
MAGE-A3
WT1 mRNA-electroporated Autologous Langerhans
vaccine
13-009
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Vaccine
This is a single institution, prospective, single-arm phase I trial. Patients will be accrued only from and treated at MSKCC. The study will assess autologous LCs presenting CT7, MAGE-A3, and WT1 after electroporation with CT7, MAGE-A3, and WT1 mRNA. Nine patients will accrue to the study and will receive vaccines at 9x106 LCs per dose (i.e., combination of 3x106 CT7 mRNA-electroporated LCs + 3x106 MAGE-A3 mRNA-electroporated LCs + 3x106 WT1 mRNA-electroporated LCs). Autologous LCs will be generated ex vivo from CD34+ hematopoietic progenitor cells (HPCs) under the aegis of defined cytokines. LCs will be electroporated with CT7, MAGE-A3, and WT1 mRNA encoding full-length CT7, MAGE-A3, and WT1. The fully mature, antigen-loaded LCs will be injected intradermally into eligible patients.
Biological: CT7, MAGE-A3, and WT1 mRNA-electroporated Langerhans cells ( LCs)
Patients will receive a total of 3 vaccinations, comprising a primary immunization on day +12 after autologous SCT followed by two boosters at days +30 and +90 (±4 days at all time points). Vaccines will be dosed at 9x106 LCs per vaccine x 3.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. safety
[ Time Frame: 1 year ]

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.
Secondary Outcome Measures:
1. Immune response monitoring
[ Time Frame: 1 year ]

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.
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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.
  • Has signed separate informed consent for stem cell mobilization and high-dose chemotherapy/autologous SCT, and deemed eligible for autologous SCT by standard institutional criteria.
  • Age ≥18 years.
  • Documentation of CT7, MAGE-A3, or WT1 expression in the bone marrow and bone marrow aspiration sample containing malignant plasma cells that has been deposited in the Hematologic Oncology Tissue Bank for post-vaccine response assessments.

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.
Open or close this module Contacts/Locations
Central Contact Person: David Chung, MD PhD
Telephone: 212-639-6617
Central Contact Backup: James Young, MD
Telephone: 646-888-2052
Study Officials: David Chung, MD, PhD
Principal Investigator
Memorial Sloan Kettering Cancer Center
Locations: United States, New York
Memorial Sloan-Kettering Cancer Center
[Recruiting]
New York, New York, United States, 10065
Contact:Contact: David Chung, MD, PhD 212-639-6617
Contact:Contact: James Young, MD 646-888-2052
Contact:Principal Investigator: David Chung, MD, PhD
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Links: Description: Memorial Sloan-Kettering Cancer Center
Available IPD/Information:

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