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Trial of Donor T Cells Sensitized With Pentadecapeptides of the CMV-PP65 Protein for the Treatment of Cytomegalovirus (CMV) Infections Following Allogeneic Hematopoietic Stem Cell Transplants

NCT00674648 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-03-11

No results posted yet for this study

Summary

The purpose of this study is to test the safety of a transfusion of specialized white cells from your transplant donor's blood, called T-cells, that have been grown and immunized against the CMV virus in the test tube. If the transplant donor is immune to CMV (ie: the donor has antibody to CMV in the blood), the T-cells will be selected and grown from the blood of the transplant donor. However, if the transplant donor is not immune to CMV, or if T-cells from the donor are not readily available, CMV-immune T-cells grown from the blood of another normal donor who is partially matched to the patients tissue type can be used. The transplant physician will explain which of these treatments is available to the patient.

This trial is called a phase I trial because phase I trials are designed to test the safety of different doses of an experimental treatment. We want to find out what effects, good and/or bad, a dose/doses of these immune T-cells will have on the patient and on the CMV infection.

Specifically, we wish to test CMV immune T-cells grown from your blood using a new method developed at our center. In this method, fragments of an important CMV protein, called CMVpp65, are chemically synthesized and then used to immunize T-cells in the test tube.

Conditions

  • Cytomegalovirus Infections

Interventions

BIOLOGICAL

CMV-Peptide-Specific T cells

In this phase I trial, five escalating dose levels will be tested. Each dose will be administered to groups of at least 3 and up to 6 patients. Dose escalation will be based on the dose limiting toxicity (DLT) observed in each treatment group (Confer Biostatistics). The patient groups and donors are outlined as follows: Group I will receive a single dose of 5 x 105 T cells/kg body weight/dose; Group II will receive a single dose of 1 x 106 T cells/kg/dose; and group III will receive a single dose of 2 x 106 T cells/kg/dose; group IV will receive 3 weekly doses of 1 x 106 T cells/kg/dose; group V will receive 3 weekly doses of 2 x 106 T cells/kg/dose.

Sponsors & Collaborators

Principal Investigators

  • Susan Prockop, MD · Memorial Sloan Kettering Cancer Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2007-08-31
Primary Completion
2014-03-31
Completion
2014-03-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00674648 on ClinicalTrials.gov