Bioengineered Allogeneic Immune Cells (AlloStim) Not Requiring HLA Donor Match for Blood Cancers
Stopped early · Phase 1/Phase 2
Conditions studied: Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma
In brief
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.
Key facts
- Study ID
- NCT00861965
- Run by
- Mirror Biologics, Inc.
- People needed
- 2
- Starts
- 2010-01-01
- Expected to finish
- 2011-04-01
- Last updated by the study team
- 2020-01-22
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Histologically confirmed hematological malignancy of 1 of the following types:
- Acute Myeloid Leukemia (AML) meeting the following criteria:
- Relapsed or primary refractory disease with ≤ 10% blasts in the peripheral blood and ≤ 20% blasts in the bone marrow.
- Acute Lymphoblastic Leukemia (ALL) meeting the following criteria:
- Relapsed or primarily refractory disease with ≤ 10% blasts in the peripheral blood and ≤ 20% blasts in the bone marrow
- Chronic Myeloid Leukemia (CML)* with an inadequate response to imatinib meeting 1 of the following criteria:
- Second or subsequent chronic phase
- Accelerated phase [*Patients with CML in blast crisis (> 30% promyelocytes and myeloblasts in the bone marrow) are not eligible]
- Non-Hodgkin's Lymphoma (NHL) including Mantle Cell Lymphoma (MCL) meeting 1 of the following criteria:
- Primary refractory disease or in refractory relapse
- Relapsed disease after autologous stem cell transplantation
- Chemosensitive relapsed disease without CR to standard salvage therapy AND no option for autologous stem cell transplantation due to blood or marrow involvement or failure to harvest sufficient autologous stem cells.
- Chronic Lymphocytic Leukemia (CLL) meeting both of the following criteria:
- Stage III or IV disease
- Refractory to fludarabine, Rituxan® and Campath® or refuses
- Multiple Myeloma (MM) meeting 1 of the following criteria:
- Primary refractory disease or in refractory relapse
- Relapsed disease after autologous stem cell transplantation
- Hodgkin's Disease
- Relapsed after prior autologous transplant or after 2 or more combination chemotherapy regimens and ineligible for autologous stem cell transplant.
- EBV driven lymphoproliferative disorders in immunocompetent patients progressing despite standard therapies, including:
- T-cell Non-Hodgkin's Lymphoma
- Burkitt's Lymphoma
- EBV+ Hodgkin's Disease
- Ability to comprehend the investigational nature of the study and provide informed consent.
You may not qualify if…
- No pregnancy or breast feeding
- No known human immunodeficiency virus (HIV+)
- No seropositivity or active viral hepatitis (HBV+, HCV+)
- No prior allogeneic transplant (cell or organ)
- No serious concomitant medical or psychiatric conditions that could interfere with treatment.
- No EBV-induced lymphomas associated with immunosuppression, including patients with iatrogenic immunodeficiencies (such as organ transplant) or HIV-related immunodefiency.
- No chronic myelogenous leukemia in blast crisis.
- No myelodysplastic syndromes with refractory anemia
Where it is running
- Immunovative Clinical Research, Inc — Carlsbad, California, United States
Full record on ClinicalTrials.gov
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