Treated T Cells Followed by a Stem Cell Transplant in Treating Patients With Multiple Myeloma



Status:Archived
Conditions:Cancer, Blood Cancer, Hematology
Therapuetic Areas:Hematology, Oncology
Healthy:No
Age Range:Any
Updated:7/1/2011
Start Date:September 2009

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Induction of Anti-Myeloma Stem Cell Immunity With Infusions of Autologous Activated T Cells Armed With OKT3 x Rituxan (Anti-CD3 x Anti-CD20) Bispecific Antibody (CD20Bi) (Phase I).


RATIONALE: Giving chemotherapy followed by treated T cells before a stem cell transplant
stops the growth of cancer cells by stopping them from dividing or by killing them. After
treatment, stem cells are collected from the patient's blood and stored. High-dose
chemotherapy is given to prepare the bone marrow for the stem cell transplant. The stem
cells are then returned to the patient to replace the blood-forming cells that were
destroyed by the chemotherapy.

PURPOSE: This phase I trial is studying the side effects and best way to give treated T
cells followed by stem cell transplant in treating patients with multiple myeloma.


OBJECTIVES:

Primary

- To test the feasibility and safety of infusing anti-CD3 x anti-CD20 bispecific
antibody-armed activated T cells (CD20Bi-AATC) before stem cell mobilization and
collection for autologous peripheral blood stem cell transplantation (PBSCT) in
patients with multiple myeloma.

Secondary

- To explore functional changes in immune cell populations as a consequence of
immunotherapy to test the hypothesis that CD20Bi-AATC can induce anti-clonogenic
myeloma precursor cell (CMPC) effect as measured by cytotoxicity; serum cytokine
levels; and serum antibody titers to myeloma cells pre-immunotherapy, after
immunotherapy, and after high-dose chemotherapy and autologous PBSCT.

- To explore whether the infusion of CD20Bi-AATC reduces the proportion of plasma cells
with the CD20+ CMPC phenotype in patients' bone marrow as assessed by multi-color flow
cytometry before and after immunotherapy.

- To assess the proportion of bone marrow colony-forming assays before induction or
salvage chemotherapy, pre-immunotherapy, and post-immunotherapy to determine whether
the infusion grossly affects the bone marrow progenitor populations.

- To explore whether infusions of CD20Bi-AATC induce a B-cell defect causing an
immunoglobulin deficiency after autologous PBSCT.

- To measure immunoglobulin deficiency after autologous PBSCT (e.g., quantitative IgG,
IgM, and IgA levels and number of circulating T- and B-cell subsets).

OUTLINE: After completion of induction or salvage chemotherapy, patients receive
immunotherapy comprising anti-CD3 x anti-CD20-armed ATC IV weekly for 2 weeks. At least 1-3
weeks after the second infusion, patients receive high-dose chemotherapy and then undergo
autologous peripheral blood stem cell transplantation. Patients then undergo leukapheresis
for G-CSF-mobilized autologous T-cells.

Blood samples are collected periodically to evaluate antibody titers to recall antigens;
serum IgG, IgM, and IgA levels; the proportion of circulating B-cells by phenotyping for
CD19, CD20, CD22, CD23, CD4, CD8, and CD38; the ability of peripheral blood mononuclear
cells to kill multiple myeloma cell lines or the patient's own cryopreserved myeloma cells
via cytotoxicity assays and ELISPOT assays; and human anti-mouse antibody responses to
murine IgG2a (OKT3). Bone marrow biopsies are also collected to analyze the phenotype of
cells (CD20+, CD138-, CD27+, CD22, etc.) via flow cytometry and the proportion of plasma
cells via flow cytometry and hematoxylin-and-eosin staining.

After completion of study treatment, patients are followed up for up to 1 year.


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6071 West Outer Drive
Detroit, Michigan 48235
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4201 St Antoine St
Detroit, Michigan 48201
(313) 577-1429
Wayne State University/Detroit Medical Center Founded in 1868, the Wayne State University School of Medicine...
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