NCT00861965

Bioengineered Allogeneic Immune Cells (AlloStim) Not Requiring HLA Donor Match for Blood Cancers

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Mirror Biologics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma

Interventions

Type	Name	Description
BIOLOGICAL	AlloStim-8	intravenous infusion of mis-matched AlloStim-8
BIOLOGICAL	AlloStim-8	intravenous infusion of AlloStim-8 on day 7
BIOLOGICAL	AlloStim-8	intravenous infusion of AlloStim-8 on day 14
BIOLOGICAL	AlloStim-8	intravenous infusion of AlloStim-8 on day 21

Timeline

• Start date: 2010-01-01
• Primary completion: 2011-03-01
• Completion: 2011-04-01
• First posted: 2009-03-16
• Last updated: 2020-01-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study