Phase I/II Combination Immunotherapy After ASCT for Advanced Myeloma to Study HTERT Vaccination Followed by Adoptive Transfer of Vaccine-Primed Autologous T Cells
This protocol proposes to combine two different investigational products to test the
hypothesis that autologous T cell therapy can augment the potency of a putative tumor
vaccine post- stem cell transplant, and lead to a myeloma-directed T-cell mediated "graft
vs. myeloma" effect in patients with advance myeloma. The hope is that this combination
therapy approach will result in a more rapid recovery of acquired immunity and consequently
increased cure rates and better clinical outcomes. The two investigational products to be
evaluated in this Phase I/II study include:
1. hTERT Vaccine (the putative tumor vaccine)- a multi-peptide vaccine consisting of 3
peptides against the catalytic subunit of telomerase (hTERT D988Y, I540, and R572Y), 1
survivin peptide (Sur1M2- an antiapoptotic protein), and 1 CMV (cytopeptide (N495).
2. T cell therapy- T-cells isolated from the patient and activated/expanded ex vivo by
antiCD3/28 beads.
This is a two-site study at the University of Pennsylvania and University of Maryland to
recruit a total of fifty-six study patients. The key eligibility criteria are patients who
have systemic or multifocal myeloma requiring autologous stem cell transplantation. After
enrollment, patients will be divided into two arms (A and B) according to their HLA A2
status (A = HLA A2 +, B = HLA A2-). Patients in ARM A will be initially immunized with the
hTERT vaccine along with a pneumococcal conjugate vaccine (PCV); patients in ARM B will be
initially immunized and given boosters of PCV only. All patients will undergo T-cell
harvest, stem cell mobilization and collection, high-dose chemotherapy, autologous stem cell
transplant (ASCT), and an infusion of expanded T cells at day 2 after ASCT. Patients in ARM
A will then receive three hTERT/PCV vaccine boosters at day 14, 42, and 90 after ASCT.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Does combination therapy delay hematopoietic recovery or induce other autoimmune events.
2 yrs
Yes
Carl H June, MD
Study Chair
University of Pennsylvania
United States: Food and Drug Administration
UPCC 13406 / GCC610
NCT00834665
December 2006
December 2015
Name | Location |
---|---|
University of Pennsylvania | Philadelphia, Pennsylvania 19104 |
Greenbaum Cancer Center | Baltimore, Maryland 21201-1595 |