A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Hadassah Medical Organization
Information provided by (Responsible Party):
Immunovative Therapies, Ltd.
ClinicalTrials.gov Identifier:
NCT00558675
First received: November 13, 2007
Last updated: November 29, 2012
Last verified: November 2012

November 13, 2007
November 29, 2012
December 2009
December 2012   (final data collection date for primary outcome measure)
Determination of toxicity related to AlloStim infusion in accordance with NCI Common Toxicity Criteria v.3 [ Time Frame: Within first 48 hours post infusion, at 30 days and at 60 days post infusion ] [ Designated as safety issue: Yes ]
Determination of toxicity related to AlloStim infusion in accordance with NCI Common Toxicity Criteria v.3 [ Time Frame: Within first 48 hours post infusion, at 30 days and at 60 days post infusion ]
Complete list of historical versions of study NCT00558675 on ClinicalTrials.gov Archive Site
  • Evaluation and reporting of anti-tumor response will be conducted in accordance with internationally accepted criteria for the disease indication being evaluated [ Time Frame: 30 days and 60 days post infusion and yearly thereafter ] [ Designated as safety issue: No ]
  • Immunological Response [ Time Frame: 30 days, 60 days ] [ Designated as safety issue: No ]
Evaluation and reporting of anti-tumor response will be conducted in accordance with internationally accepted criteria for the disease indication being evaluated [ Time Frame: 30 days and 60 days post infusion and yearly thereafter ]
Not Provided
Not Provided
 
A Phase I/II Study of Mis-Matched Immune Cells (AlloStim) in Patients With Advanced Hematological Malignancy
A Phase I/II Study of Intentionally Mis-Matched, Allogeneic Th1 Memory Cells (AlloStim) Conjugated With CD3/CD28-coated Microbeads in Patients With Relapsed or Refractory Hematological Malignancy

The purpose of this study is to determine the safety and anti-tumor effects of an experimental immunotherapy drug, called AlloStim, which is intentionally mis-matched immune cells which are designed to elicit the same anti-tumor mechanism that occurs in allogeneic bone marrow/stem cell mini-transplant (BMT) procedures, without the toxicity associated with graft vs. host disease (GVHD).

AlloStim is combination biological drug and medical device formulation consisting of allogeneic immune cells that have been expanded and differentiated ex-vivo. These cells are conjugated to monoclonal antibody coated microparticles prior to infusion. The immune cells are living CD4+ memory Th1-like T-cells (T-Stim) that are differentiated from precursors purified from normal donor blood. AlloStim is a composition of T-Stim cells conjugated to paramagnetic epoxy covered microparticles (4.5micron) with covalently bound anti-CD3/anti-CD28 monoclonal antibodies (Dynabeads® ClinExVivo™ CD3/CD28) at a 2:1 bead:cell ratio. The T-Stim cells are intentionally mismatched to the recipient.

The graft vs. tumor (GVT) effect that occurs after allogeneic bone marrow transplant (BMT) is a curative therapy for advanced hematological malignancy but the clinical application of GVT is severely limited by graft vs. host disease (GVHD) toxicity. AlloStim is designed to elicit the "mirror" of the GVT/GVHD effects in the host immune system. Rather than trying to separate these effects, we have proposed that the effects could remain associated and "mirrored" onto the host immune system creating linked host vs. tumor (HVT) and host vs. graft (HVG) effects. We hypothesized that allogeneic Th1 memory cells activated at time of infusion to produce type 1 cytokines and express CD40L would elicit HVT/HVG "mirror effects" in immunocompetent cancer patients.

Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Hematological Malignancy
  • Leukemia
  • Lymphoma
  • Multiple Myeloma
  • Biological: AlloStim
    single intravenous infusion of 1 x 10^9 AlloStim cells
  • Biological: AlloStim
    Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7
  • Biological: AlloStim
    Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7 and day 14
  • Biological: AlloStim
    Intravenous infusion of 1 x 10^9 AlloStim on day 1 and a second intravenous infusion of 1 x 10^8 AlloStim on day 7, day 14 and day 21
  • Experimental: 1
    Single intravenous infusion of AlloStim
    Intervention: Biological: AlloStim
  • Experimental: 2
    Intravenous AlloStim infusion on day 1 and day 7
    Intervention: Biological: AlloStim
  • Experimental: 3
    Intravenous AlloStim infusion on day 1, day 7 and day 14
    Intervention: Biological: AlloStim
  • Experimental: 4
    Intravenous AlloStim infusion on day 1, day 7, day 14 and day 21
    Intervention: Biological: AlloStim

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
25
March 2013
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • histologically confirmed hematological malignancy
  • unresponsive to chemotherapy and/or recurrence after autologous transplant
  • adequate kidney, liver, lung and heart function

Exclusion Criteria:

  • prior allogeneic transplant
  • immunosuppressive therapy for concurrent medical condition
  • active viral infection
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT00558675
ITL-001-HMC
No
Immunovative Therapies, Ltd.
Immunovative Therapies, Ltd.
Hadassah Medical Organization
Principal Investigator: Dr. Michael Har-Noy Immunovative Therapies
Immunovative Therapies, Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP