MedTrace Logo

Cytotoxic T Cells to Prevent Virus Infections

NCT01923766 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2020-07-14

No results posted yet for this study

Summary

In this study, investigators are trying to see if infusion of "m-CTLs" will prevent or treat cytomegalovirus (CMV), Epstein Barr Virus (EBV) and adenovirus (AdV) reactivation or infection after cord blood transplant.

Patients with blood cell cancer, other blood disease or a genetic disease may receive a cord blood transplant (UCBT) from an unrelated donor. After receiving a cord blood transplant, they are at risk of infections until a new immune system to fight infections grows from the cord blood cells. In this study, investigators are trying to give special cells from the cord blood called T cells. These cells will try to fight viruses that can cause infection.

Investigators will test to see if blood cells from donor that have been grown in a special way, can prevent patients from getting an infection. EBV, AdV and CMV are viruses that can cause serious life-threatening infections in patients who have weak immune systems after transplant.

T lymphocytes can kill viral cells but normally there are not enough of them to kill all the virus infected cells after transplant. Some researcher have taken T cells from a person's blood, grown more of them in the laboratory and then given them back to the person during a viral infection after a bone marrow transplant. Some of these studies have shown a positive therapeutic effect in patients receiving the CTLs (specially trained T cells) after a viral infection in the post-transplant period. In this study we are trying to prevent or treat viral infections by given the CTLs soon after getting the umbilical cord blood transplant.

With this study, investigators want to see if they can use a kind of white blood cell called T cells to prevent or treat AdV, EBV and CMV infection. Investigators will grow these T cells from the cord blood before transplant. These cells have been trained to attack adenovirus/EBV/CMV- infected cells and are called multivirus-specific cytotoxic (killer) T-cells or "m-CTL." Investigators would plan to give patients one dose of m-CTL any time from 30 to 364 days after your transplant. They have used T cells made in this way from the blood of donors to prevent infections in patients who are getting a bone marrow or blood stem cell transplant but this will be the first time investigators make them from cord blood.

Conditions

  • CMV
  • EBV
  • Adenovirus Infections

Interventions

DRUG

Cytotoxic T lymphocytes (CTLs).

This Phase I dose-escalation trial is designed to evaluate the safety of donor-derived cytotoxic T lymphocytes (CTLs). Dose escalation is guided by the modified continual reassessment method (mCRM) in order to determine the maximum tolerated dose (MTD). For each group, MTD is defined as the dose at which the probability of DLT is at most 21%. Four dose levels are being evaluated namely, 5x106 cells/m2, 1.0x107 cells/m2, 1.5x107 cells/m2 and 2.5x107 cells/m2 with prior probabilities of toxicity estimated at 5%, 7.1%, 10% and 21%, respectively. Two patients are allocated in each cohort and are followed for 30 days post IV injection for evaluation of DLTs. The trial continues until a minimum of 12 patients have been treated and stop when the maximum 18 patients have been treated.

Sponsors & Collaborators

  • M.D. Anderson Cancer Center

    collaborator OTHER

  • Children's National Research Institute

    lead OTHER

Principal Investigators

  • Catherine M Bollard, M.D · Children's National Research Institute

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2020-03-25
Completion
2020-03-25

Countries

  • United States

Study Locations

More Related Trials

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 NCT01923766 on ClinicalTrials.gov