Adoptive Immunotherapy for CMV Disease

Prevention and Treatment of CMV Disease by Adoptive Immunotherapy With Immune Donor Lymphocytes in Conjunction With Non-myeloablative Stem Cell Transplantation (NST)

Status

Withdrawn

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00159055

Enrollment

Registered

2005-09-12

Start date

2004-02-29

Completion date

Unknown

Last updated

2011-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CMV Disease

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.

Interventions

BIOLOGICALCMV vaccine

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

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.)

Design outcomes

Primary

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

Secondary

Measure	Time frame
Evaluate toxicity of the procedure.	—

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026