CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease

A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease

Status

Terminated

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00611637

Acronym

CMV-BMT

Enrollment

Registered

2008-02-11

Start date

2005-08-31

Completion date

2008-06-30

Last updated

2012-11-12

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

Conditions

Allogeneic Stem Cell Transplantation

Keywords

Immunotherapy

Brief summary

The purpose of this study is to determine the safety and feasibility of CMV specific, T cell adoptive immunotherapy in patients who have undergone allogeneic stem cell transplantation for malignant disease.

Detailed description

The primary purpose of this clinical trial is to evaluate the safety of this treatment.

Interventions

BIOLOGICALCMV pp65 Specific T Cells

Donor derived CMV pp65 specific T cells (1 x 105 CD3+ cells/kg (maximum 1 x 107 CD3+ cells) will be infused into recipient over 10 minutes.

Study design

Allocation

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stratum 1: Subjects must be undergoing a non-myeloablative stem cell transplant from a 6/6 matched, sibling donor for the treatment of a malignancy * Stratum 2: Subjects must be undergoing a non-myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy. * Stratum 3: Subjects must be undergoing a myeloablative stem cell transplant from a 3/6, 4/6, or 5/6 matched, sibling donor for the treatment of a malignancy. * Donor must be CMV sero-positive. * Karnofsky performance status ≥ 70%. * Subject and donor must be one of the following HLA types: HLA A\*0201, HLA-A\*0101, HLA-A\*2402, HLA-B\*0702, HLA-B\*0801, HLA-B\*35, HLA-DR\*1, or HLA-DR\*4. * Availability of the stem cell donor to provide multiple PBMC samples for T-cell culture if needed. These samples could be obtained via a 90cc peripheral blood draw or through leukapheresis. Stem cell donor must satisfy BMT Program criteria for undergoing leukapheresis to provide DLI and consent to provide repeat leukapheresis if this is necessary. * Ability to understand and provide signed informed consent that fulfills Institutional Review Board guidelines. * Ability to return to Duke University Medical Center for adequate follow-up as required by this protocol. * In order to receive their T cell infusions, subjects should be: * At least 2 weeks from the time of their allogeneic stem cell transplant. * Without Grade 3 or 4, non-hematologic, major organ toxicity within the preceding 1 week; all non major organ toxicities must have resolved to grade-2 or less.

Exclusion criteria

* Pregnant women and nursing mothers. * Current or prior history of brain metastases. * More than 12 months since their allogeneic stem cell re-infusion. * HIV+, Hepatitis BsAg+, Hepatitis C Ab+

Design outcomes

Primary

Measure	Time frame
Number of CMV pp65 specific CD8+ T cells produced.	Pre-infusion.
Development of grade III-IV GVHD or major organ toxicity.	Continuously for 100 days post-transplant.

Secondary

Measure	Time frame
Presence of CMV in peripheral blood.	Tested before and following transplant and infusion.
Percentage of CD8+ T cells that are CMV pp65 specific.	Assessed weekly up to 6 months following T cell infusion.

Countries

United States

Outcome results

None listed

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