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

Phase 1

Completed

• Conditions: Lymphoma; Multiple Myeloma
• Interventions: Biological: CMV-MVA Triplex Vaccine

• Registration Number: NCT03383055
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-11
• Study First Submitted QC: 2017-12-21
• Study First Posted: 2017-12-26
• Study Start: 2018-11-16
• Primary Completion: 2021-07-10
• Study Completion: 2021-07-10
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-11
• Last Update Posted: 2021-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CMV positive cohort	CMV-MVA Triplex Vaccine	CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT
CMV negative cohort	CMV-MVA Triplex Vaccine	CMV-MVA Triplex vaccine administered on days 28 and 56 post-HCT

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.
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).
Progression Free Survival (PFS)	1 Year	Incidence of progression-free survival at 1 year in patients receiving CMV-MVA Triplex vaccine with historical controls

Trial Locations

Locations (1)

Masonic Cancer Center at University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States