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Completed

NCT Number: NCT03383055

CMV-MVA Triplex Vac.Enhance Adap. NK Cell Recon. After Auto HSCT in pt Lymphoid Malig

This is a prospective, interventional study administering 2 doses of the experimental vaccine (CMV-MVA Triplex) to 20 evaluable patients (10 CMV-seropositive and 10 seronegative) undergoing autologous hematopoietic cell transplantation (HCT) for lymphoma or myeloma on days 28 and 56 post-HCT. The absolute number of adaptive NK cells (CD56dimCD57+NKG2C+) at various days will be compared.

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Key information

Conditions

Lymphoma Blood Protein Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Hemostatic Disorders Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Multiple Myeloma Neoplasms Neoplasms by Histologic Type Neoplasms, Plasma Cell Paraproteinemias Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Masonic Cancer Center at University of Minnesota

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age > 18 years
  • Lymphoma or multiple myeloma
  • Planned co-enrollment on current (at the time of this study version) or future (opening subsequent to this study) standard of care autologous stem cell transplant protocol.
  • Must meet all eligibility requirements of the co-enrolled parent study
  • Sexually active females of childbearing potential and males with partners of child-bearing potential must agree to use adequate birth control until at least day 100 post-HCT
  • Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

Exclusion criteria

  • CMV immunoglobulin, valganciclovir, ganciclovir, foscarnet, or other anti-CMV therapy within 3 months before the first vaccine is planned. Acyclovir and valacyclovir are allowed.
  • Pregnant or breast feeding. The FDA has not classified this agent into a specified pregnancy category. Females of childbearing potential must have a blood test or urine study within 14 days prior to registration to rule out pregnancy
  • Planned immunotherapy post-HCT. Proteasome inhibitors and/or immunomodulators, such as but not limited to Lenalidomide or Pomalidomide, used for myeloma maintenance are allowed.

Treatment and study plan

CMV-MVA Triplex Vaccine

Biological
  • CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
  • TDap administered on Day 56

Primary outcomes

  1. Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) between days 28 and 100 post-auto-HCT in patients with lymphoid malignancies.

    Time frame: Day 28 and Day 100

    Change in the absolute number of CMV-induced adaptive NK cells (CD56dimCD57+NKG2C+) on day 28 (pre first vaccine) and day 100 (~1 month after second vaccine) post-auto- HCT in patients with lymphoid malignancies.

Secondary outcomes

  1. Change in absolute Number of CMV-induced adaptive NK Cells

    Time frame: Day 28 and Day 100

    Change in absolute number of total NK and NK/T cells between days 28 (first vaccine) and day 100 (~1 month after second vaccine) post-auto-HCT in patients with lymphoid malignancies (lymphoma and myeloma).

  2. Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients

    Time frame: Day 28 and Day 100

    Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.

  3. Progression Free Survival (PFS)

    Time frame: 1 Year

    Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls

  4. Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients

    Time frame: Day 28 and Day 100

    Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Official study title

CMV-MVA Triplex Vaccine to Enhance Adaptive NK Cell Reconstitution After Autologous Hematopoietic Cell Transplantation in Patients With Lymphoid Malignancies

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Dec 26, 2017
Registry last updated
Aug 17, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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