At a glance
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Phase 1-2 Study of a CpG-Activated Whole Cell Vaccine Followed by Autologous "Immunotransplant" for Mantle Cell Lymphoma
In Brief
A Phase 2 clinical trial evaluating CpG-MCL vaccine, PF-3512676, and 6 other interventions for Lymphoma, Mantle-Cell. Completed, enrolled 59 participants across 1 site.
Detailed Summary
Mantle cell lymphoma (MCL) is a sub-type of non-Hodgkin's lymphoma (NHL) which is generally considered incurable with current therapy. Participants will receive an autologous vaccine against their individual lymphoma after undergoing stem cell transplantation. This vaccination may prolong the time which patients will stay in remission from their disease.
Study Details
Timeline
Interventions
CpG-MCL vaccine is a vaccine prepared by co-culturing cells from the participant's mantle cell lymphoma suspension with 3 mcg/mL PF-3512676, then irradiated to 200 Gy. 1 x 10e8 CpG-MCL cells will be given as a subcutaneous injection.
PF-03152676 is a synthetic immunostimulatory, single-stranded oligodeoxynucleotide (oligo-DNA) moledule containing unmethylated cytosine and guanine (CpG) motifs. PF-03512676 acts as an agonist of human Toll-like receptor 9, leading to activation of antigen-presenting cells and a cascade of antitumor immune reactions.
Vaccine primed T-cells are the post-vaccination leukapheresis harvest of peripheral blood mononuclear cells. Each collection is approx 1 x 10e10 CD3+ T-cells.
Regular medical procedure
375 mg/m² by infusion
Patient-specific, regular medical care treatment as determined by treating oncologist
Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)
Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)