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

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

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.

Study Overview

• Status: Completed
• Conditions: Lymphoma; Multiple Myeloma
• Intervention / Treatment: Biological: CMV-MVA Triplex Vaccine

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Masonic Cancer Center at University of Minnesota

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CMV positive cohort; CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT	Biological: CMV-MVA Triplex Vaccine; CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT; TDap administered on Day 56
Experimental: CMV negative cohort; CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT	Biological: CMV-MVA Triplex Vaccine; CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT; TDap administered on Day 56

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Day 28 and Day 100

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in absolute Number of CMV-induced adaptive NK Cells	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).	Day 28 and Day 100
Response to CMV-MVA Triplex vaccine in CMV seropositive vs. seronegative patients	Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.	Day 28 and Day 100
Progression Free Survival (PFS)	Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls	1 Year
Response to CMV-MVA Triplex vaccine in lymphoma vs. myeloma patients	Change in the absolute number of adaptive NK cells between day 28 post-transplant and day 100.	Day 28 and Day 100

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Armin Rashidi, MD, PhD, University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 16, 2018
• Primary Completion (Actual): July 10, 2021
• Study Completion (Actual): July 10, 2021

Study Registration Dates

• First Submitted: December 11, 2017
• First Submitted That Met QC Criteria: December 21, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): August 17, 2021
• Last Update Submitted That Met QC Criteria: August 11, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Immunoproliferative Disorders; Hematologic Diseases; Hemorrhagic Disorders; Hemostatic Disorders; Paraproteinemias; Blood Protein Disorders; Neoplasms, Plasma Cell; Multiple Myeloma
• Other Study ID Numbers: 2017LS091; MT2017-29 (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No