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

NCT00861965 | Terminated Phase 1 FDA Drug

• 1 other identifier: ITL-001-HM
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Advanced or Refractory Leukemia, Lymphoma, Multiple Myeloma

Keywords

Leukemia; Lymphoma; Multiple Myeloma

Outcome Measures

Primary Outcomes (2)

• To evaluate the safety of administration of an intravenous AlloStim-9 infusion and to define any drug-related toxicity and reversibility of such toxicity

  7 days

• 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

  90 days

Secondary Outcomes (1)

• evaluate the anti-tumor effect of AlloStim infusions by evaluating the objective response rates

  90 days

Study Arms (1)

Treatment

EXPERIMENTAL

AlloStim-8

Biological: AlloStim-8

Interventions

AlloStim-8 BIOLOGICAL

intravenous infusion of mis-matched AlloStim-8

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

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

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (1)

Immunovative Clinical Research, Inc

Carlsbad, California, 92010, United States

Location

Related Publications (3)

• Har-Noy M, Zeira M, Weiss L, Fingerut E, Or R, Slavin S. Allogeneic CD3/CD28 cross-linked Th1 memory cells provide potent adjuvant effects for active immunotherapy of leukemia/lymphoma. Leuk Res. 2009 Apr;33(4):525-38. doi: 10.1016/j.leukres.2008.08.017. Epub 2008 Oct 1.

  PMID: 18834631 BACKGROUND

• Har-Noy M, Zeira M, Weiss L, Slavin S. Completely mismatched allogeneic CD3/CD28 cross-linked Th1 memory cells elicit anti-leukemia effects in unconditioned hosts without GVHD toxicity. Leuk Res. 2008 Dec;32(12):1903-13. doi: 10.1016/j.leukres.2008.05.007. Epub 2008 Jun 18.

  PMID: 18565579 BACKGROUND

• Har-Noy M, Slavin S. The anti-tumor effect of allogeneic bone marrow/stem cell transplant without graft vs. host disease toxicity and without a matched donor requirement? Med Hypotheses. 2008;70(6):1186-92. doi: 10.1016/j.mehy.2007.10.008. Epub 2007 Dec 3.

  PMID: 18054441 BACKGROUND

MeSH Terms

Conditions

Leukemia; Lymphoma; Multiple Myeloma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Neoplasms, Plasma Cell; Hemostatic Disorders; Vascular Diseases; Cardiovascular Diseases; Paraproteinemias; Blood Protein Disorders; Hemorrhagic Disorders

Study Officials

• Dr. Michael Har-Noy

  Mirror Biologics, Inc.

  STUDY DIRECTOR

• Michael Berger, MD

  Immunotherapy Clinical Associates, PC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 12, 2009
• First Posted: March 16, 2009
• Study Start: January 1, 2010
• Primary Completion: March 1, 2011
• Study Completion: April 1, 2011
• Last Updated: January 22, 2020

Record last verified: 2015-04

Locations

US (1)