Basic Trial Information
Trial Description
Summary
Further Trial Information
Eligibility Criteria
Trial Contact Information
| Phase | Type | Status | Age | Sponsor | Protocol IDs |
|---|---|---|---|---|---|
| Phase II, Phase I | Treatment | Active | 18 and over | Pharmaceutical / Industry | ITL-001-HMC NCT00558675 |
Summary
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).
Further Study Information
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.
Eligibility Criteria
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
Trial Lead Organizations/Sponsors
Immunovative Therapies, Limited
Hadassah University Hospital| Dr. Michael Har-Noy |  | Principal Investigator |
| Reuven Or, MD | | Ph: 972-50-787-4464 |
| Email: reuvenor@hadassah.org.il | ||
Trial Sites
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| Israel | |||
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| Jerusalem | |||
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| Dina Ben-Yehuda, MD | Sub-Investigator | ||
| Hadassah University Hospital | |||
| Reuven Or | Principal Investigator | ||
Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00558675
Information obtained from ClinicalTrials.gov on December 14, 2011
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