Study of Bioengineered Allogeneic Immune Cells (AlloStim) Not Requiring HLA Donor Match Alternative to Allogeneic Transplant for Blood Cancers
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.
Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- To evaluate the safety of administration of an intravenous AlloStim-9 infusion and to define any drug-related toxicity and reversibility of such toxicity [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
- evaluate the safety of administration of up to three consecutive daily intravenous AlloStim-8 booster infusions in patients that previously received a infusion of AlloStim-9 and to define any drug-related toxicity and reversibility of such toxicity [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
- evaluate the anti-tumor effect of AlloStim infusions by evaluating the objective response rates [ Time Frame: 90 days ] [ Designated as safety issue: No ]
|Study Start Date:||January 2010|
|Estimated Study Completion Date:||December 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
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.
|United States, California|
|Immunovative Clinical Research, Inc|
|Carlsbad, California, United States, 92010|
|Study Director:||Dr. Michael Har-Noy||Immunovative Therapies, Ltd.|
|Principal Investigator:||Michael Berger, MD||Immunotherapy Clinical Associates, PC|