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

NCT00861965 · Status: TERMINATED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2020-01-22

No results posted yet for this study

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

Interventions

BIOLOGICAL

AlloStim-8

intravenous infusion of mis-matched AlloStim-8

BIOLOGICAL

AlloStim-8

intravenous infusion of AlloStim-8 on day 7

BIOLOGICAL

AlloStim-8

intravenous infusion of AlloStim-8 on day 14

BIOLOGICAL

AlloStim-8

intravenous infusion of AlloStim-8 on day 21

Sponsors & Collaborators

  • Mirror Biologics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Michael Har-Noy · Mirror Biologics, Inc.

  • Michael Berger, MD · Immunotherapy Clinical Associates, PC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2011-03-31
Completion
2011-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT00861965 on ClinicalTrials.gov