DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab

PHASE2Active, not recruitingINTERVENTIONAL
Enrollment

43

Participants

Timeline

Start Date

August 26, 2020

Primary Completion Date

March 31, 2026

Study Completion Date

March 31, 2026

Conditions
Glioblastoma
Interventions
BIOLOGICAL

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.

DRUG

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)

BIOLOGICAL

Varlilumab

Varlilumab is an agonist anti-CD27 monoclonal antibody

BIOLOGICAL

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

BIOLOGICAL

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.

Trial Locations (1)

27710

Duke University Medical Center, Durham

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Celldex Therapeutics

INDUSTRY

lead

Annick Desjardins, MD

OTHER

NCT03688178 - DC Migration Study to Evaluate TReg Depletion In GBM Patients With and Without Varlilumab | Biotech Hunter | Biotech Hunter