Adoptive Immunotherapy for CMV Disease

Hadassah Medical Center

Status and phase

Withdrawn

Phase 2

Phase 1

Conditions

CMV Disease

Treatments

Biological: CMV vaccine

Study type

Interventional

Funder types

Other

Identifiers

NCT00159055

280303-HMO-CTIL

Details and patient eligibility

About

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.

Enrollment

20 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

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.)