Clinical trial NCT00611637: CMV pp65 Specific T Cell Adoptive Immunotherapy in Allogeneic Stem Cell Transplantation for Malignant Disease
Official title: A Pilot Clinical Trial of CMV pp65 Specific T Cell Adoptive Immunotherapy in Patients Who Have Undergone Allogeneic Stem Cell Transplantation for Malignant Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
Conditions: Allogeneic Stem Cell Transplantation
Keywords: Immunotherapy
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Cancer Institute (NCI)
First posted: 2008-02-11
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP

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.

Eligibility criteria: 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+

Primary outcomes:
measure: Number of CMV pp65 specific CD8+ T cells produced.
timeFrame: Pre-infusion.
measure: Development of grade III-IV GVHD or major organ toxicity.
timeFrame: Continuously for 100 days post-transplant.
Secondary outcomes:
measure: Presence of CMV in peripheral blood.
timeFrame: Tested before and following transplant and infusion.
measure: Percentage of CD8+ T cells that are CMV pp65 specific.
timeFrame: Assessed weekly up to 6 months following T cell infusion.
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: H. Kim Lyerly, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Duke University
name: Michael A Morse, M.D.
role: PRINCIPAL_INVESTIGATOR
References: