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

Allogeneic Stem Cell Transplantation Clinical Trial

— CMV-BMT  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00611637
• Other study ID #: 4138-07-10R5
• Secondary ID: IND 11649
• Status: Terminated
• Phase: Phase 1
• First received: January 29, 2008
• Last updated: November 8, 2012
• Start date: August 2005
• Est. completion date: June 2008

Study information

• Verified date: November 2012
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: June 2008
• Est. primary completion date: February 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Allogeneic Stem Cell Transplantation

Intervention

Biological:
• CMV 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.

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
H. Kim Lyerly	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of CMV pp65 specific CD8+ T cells produced.		Pre-infusion.	No
Primary	Development of grade III-IV GVHD or major organ toxicity.		Continuously for 100 days post-transplant.	Yes
Secondary	Presence of CMV in peripheral blood.		Tested before and following transplant and infusion.	No
Secondary	Percentage of CD8+ T cells that are CMV pp65 specific.		Assessed weekly up to 6 months following T cell infusion.	No