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

Phase 1

Terminated

• Conditions: Allogeneic Stem Cell Transplantation
• Interventions: Biological: CMV pp65 Specific T Cells

• Registration Number: NCT00611637
• Lead Sponsor: H. Kim Lyerly

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.

Study Timeline

• Study Start: 2005-08
• Study First Submitted: 2008-01-29
• Primary Completion: 2008-02
• Study First Submitted QC: 2008-02-08
• Study First Posted: 2008-02-11
• Study Completion: 2008-06
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-08
• Last Update Posted: 2012-11-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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+

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	CMV pp65 Specific T Cells	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Duke University Medical Center; 🇺🇸 Durham, North Carolina, United States