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

NCT00558675 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2020-01-22

No results posted yet for this study

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).

Conditions

Interventions

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

Sponsors & Collaborators

  • Hadassah Medical Organization

    collaborator OTHER
  • Mirror Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Michael Har-Noy · Immunovative Therapies

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-12-31
Primary Completion
2012-12-31
Completion
2013-03-31

Countries

  • Israel

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00558675 on ClinicalTrials.gov