Phase 1-2 of a CpG-Activated Whole Cell Vaccine Followed by Autologous Immunotransplant for MCL

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.

Conditions

• Lymphoma, Mantle-Cell

Interventions

BIOLOGICAL

CpG-MCL vaccine

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.

BIOLOGICAL

PF-3512676

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.

PROCEDURE

Vaccine-primed T-cells

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.

PROCEDURE

Autologous hematopoietic stem cell transplant (HSCT)

Regular medical procedure

DRUG

Rituximab

375 mg/m² by infusion

DRUG

Standard induction chemotherapy

Patient-specific, regular medical care treatment as determined by treating oncologist

DRUG

Cyclophosphamide

Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)

DRUG

Filgrastim

Regular medical care treatment to mobilize peripheral blood progenitor cell (PBPC)

Sponsors & Collaborators

• National Institutes of Health (NIH)

  collaborator NIH

• Ronald Levy

  lead OTHER

Principal Investigators

• Ronald Levy, MD · Stanford University

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-08-31

Primary Completion

2017-12-14

Completion

2017-12-14

FDA Drug

Yes

Countries

• United States

Study Locations