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

Sponsor

Masonic Cancer Center, University of Minnesota (Other)

Overall Status

Completed

CT.gov ID

NCT03383055

Collaborator

(none)

Enrollment

Location

Arms

31.8

Actual Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Lymphoma Multiple Myeloma	Biological: CMV-MVA Triplex Vaccine	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 16, 2018

Actual Primary Completion Date :

Jul 10, 2021

Actual Study Completion Date :

Jul 10, 2021

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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. [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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Masonic Cancer Center at University of Minnesota	Minneapolis	Minnesota	United States	55455

Sponsors and Collaborators

Masonic Cancer Center, University of Minnesota

Investigators

Principal Investigator: Armin Rashidi, MD, PhD, University of Minnesota Hematology, Oncology and Transplantation Department of Medicine

Study Documents (Full-Text)

Informed Consent Form - Jun 19, 2018

More Information

Publications

None provided.

Responsible Party:

Masonic Cancer Center, University of Minnesota

ClinicalTrials.gov Identifier:

NCT03383055

Other Study ID Numbers:

2017LS091
MT2017-29

First Posted:

Dec 26, 2017

Last Update Posted:

Aug 17, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Multiple Myeloma

Study Results

No Results Posted as of Aug 17, 2021