Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma Clinical Trial
Official title:
A Phase I/II Study of Polyclonally Activated, Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStimTM) in Patients With Relapsed or Refractory Hematological Malignancy Without Prior Conditioning
This phase I/II clinical investigation is designed to determine the safety and anti-tumor effects of intravenous administration of the experimental immunotherapy drug, called AlloStim. The active ingredient of AlloStim is living, human immune cells that have been differentiated and expanded outside the body. Because AlloStim does not require HLA match, it is being evaluated as an alternative to allogeneic bone marrow/stem cell transplantation.
AlloStim is being tested to determine if it might elicit the same anti-tumor mechanism that
occurs in allogeneic bone marrow/stem cell transplant (BMT) procedures, without the toxicity
associated with graft vs. host disease (GVHD). In allogeneic BMT settings, patients are first
conditioned to weaken the immune system in order to enable the engraftment of allogeneic
donor cells. Patients require a matched-tissue donor in this setting in order to enable
engraftment and also to minimize GVHD toxicity. While allogeneic BMT is a potentially curatve
therapy, the treatment-related mortality, mostly related to GVHD toxicity, is high. This
toxicity limits the clinical utility of this procedure. AlloStim is being tested to determine
if it might be a less toxic alternative to allogeneic BMT.
In this protocol, patients are not conditioned with chemotherapy prior to treatment.
Therefore, the allogeneic cells in AlloStim are expected to be rejected by the patient's
immune system within 24-48 hours of infusion.
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