Adoptive Immunotherapy for CMV Disease

Phase 1

Withdrawn

• Conditions: CMV Disease

• Registration Number: NCT00159055
• Lead Sponsor: Hadassah Medical Organization

Brief Summary

Treatment strategy of patients:

Stem cell engraftment (myeloablative or NST) for induction of host vs graft myeloablative transplantation tolerance.

Whenever indicated, additional post NST DLI given in graded increment, to optimize control of GVHD.

Preparation of immune donor lymphocytes, either by donor immunization in-vitro with a CMV-specific peptide followed by administration of immunized donor lymphocytes, or by injection of donor lymphocytes and in-vivo sensitization of donor lymphocytes in the patient following DLI.

Pre-emptive treatment of seronegative patients at risk or patients with documented viremia or CMV disease with CMV-specific donor lymphocytes generated in-vivo in the donor or in the host by peptide immunization.

Consenting donors will be immunized with CMV-specific peptides, for induction of CTLs in-vivo following subcutaneous inoculation of peptides with adjuvant or donor APC pulsed with relevant peptides.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Status Verified: 2005-09
• Study First Submitted: 2005-09-09
• Study First Submitted QC: 2005-09-09
• Study First Posted: 2005-09-12
• Last Update Submitted: 2011-04-07
• Last Update Posted: 2011-04-08

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• For Patient:
• Consenting patients with indication for myeloablative BMT or NST with an HLA matching sibling available, for transplant.
• Patients at risk of CMV disease including seronegative patients; patients with seronegative donors, and seronegative donor for sero positive patients.
• Patients with resistant CMV viremia or CMV disease not responding to conventional treatment with ganciclovir, or Foscarnet.
• Patients with HLA phenotype for which a relevant peptide for CMV exists.
• For Donor:
• Consenting sibling >18 years old.
• HLA phenotype for which a relevant peptide for CMV exists.

Exclusion Criteria

• For Patient:
• Patients with severe resistant GVHD where there may be a risk to administer DLI or immunized donor lymphocytes.
• For Donor:
• Consenting sibling >18 years old.
• HLA phenotype for which a relevant peptide for CMV exists.
• Donor with an infectious disease (e.g. HIV-1; HBV, etc.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Induce and amplify T cell-mediated immunotherapy against cytomegalovirus (CMV) infection in stem cell allograft recipients.

Secondary Outcome Measures

Name	Time	Method
Evaluate toxicity of the procedure.

Trial Locations

Locations (1)

Hadassah Medical Organization; 🇮🇱 Jerusalem, Israel