43
Participants
Start Date
August 26, 2020
Primary Completion Date
March 31, 2026
Study Completion Date
March 31, 2026
Human CMV pp65-LAMP mRNA-pulsed autologous DCs
2x10\^7 human CMV pp65-LAMP mRNA-pulsed autologous DCs are given intradermally and bilaterally at the groin site (divided equally to both inguinal regions). Patients will receive up to a total of 10 DC vaccines.
Temozolomide
Temozolomide is a standard chemotherapy given to all enrolled patients at a targeted dose of 150-200mg/m2/d for 5 days every 4 (+ 2) weeks for up to 12 cycles (patients with unmethylated MGMT gene promoter will receive only cycle 1)
Varlilumab
Varlilumab is an agonist anti-CD27 monoclonal antibody
Td
A single dose of Td toxoid (1 flocculation unit, Lf, in 0.4 mLs) administered to a single side of the groin given intradermally
Unpulsed DCs
Patients in Group I will receive 1 x 10\^6 autologous unpulsed DCs in saline administered to a single side of the groin intradermally 1 day before the fourth vaccine.
Duke University Medical Center, Durham
Collaborators (1)
Celldex Therapeutics
INDUSTRY
Annick Desjardins, MD
OTHER