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

NCT00611637 | Terminated Phase 1

• 2 other identifiers: 4138-07-10R5IND 11649
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Allogeneic Stem Cell Transplantation

Keywords

Immunotherapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• 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.

Study Arms (1)

1

EXPERIMENTAL

Biological: CMV pp65 Specific T Cells

Interventions

CMV pp65 Specific T Cells BIOLOGICAL

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.

1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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+

Sponsors & Collaborators

• H. Kim Lyerly: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Study Officials

• H. Kim Lyerly, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

• Michael A Morse, M.D.

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor, Gen & Thor Surgery

Study Record Dates

• First Submitted: January 29, 2008
• First Posted: February 11, 2008
• Study Start: August 1, 2005
• Primary Completion: February 1, 2008
• Study Completion: June 1, 2008
• Last Updated: November 12, 2012

Record last verified: 2012-11

Locations

US (1)