RECRUITING

EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This study is for patients that have a type of lymph gland disease called Hodgkin or non-Hodgkin Lymphoma or T/NK-lymphoproliferative disease which has come back or has not gone away after treatment, including the best treatment the investigators know for these diseases. Some patients with Lymphoma or T/NK-lymphoproliferative disease show signs of virus that is sometimes called Epstein Barr virus (EBV) that causes mononucleosis or glandular fever ("mono") before or at the time of their diagnosis. EBV is found in the cancer cells of up to half the patients with Hodgkin's and non-Hodgkin Lymphoma, suggesting that plays a role in causing Lymphoma. The cancer cells (in lymphoma) and some immune system cells infected by EBV are able to hide from the body's immune system and escape destruction. T cells, also called T lymphocytes, are special infection-fighting blood cells that can kill other cells, including cells infected with viruses and tumor cells. T cells have been used to treat patients with cancers. T cells, that have been trained to kill EBV infected cells can survive in the blood and affect the tumor. The investigators have treated over 80 people on studies using T cells to target these diseases. About half of those patients who had disease at the time they got the cells had responses including some patients with complete responses. The investigators think that if T cells are able to last longer in the body, they may have a better chance of killing EBV and EBV infected tumor cells. Therefore, in this study the investigators will add a new gene to the EBV T cells that can cause the cells to live longer called C7R. The investigators know that T cells need substances called cytokines to survive and the cells may not get enough cytokines after infusion into the body. The investigators have added the gene C7R that gives the cells a constant supply of cytokine and helps them to survive for a longer period of time. The purpose of this study is to find the largest safe dose of C7R-EBV T cells, and additionally to evaluate how long they can be detected in the blood and what affect they have on cancer.

Official Title

Constitutive IL7 (C7R) Modified EBV Specific T-Lymphocytes for Treatment of EBV-Positive Lymphoma

Quick Facts

Study Start:2022-10-31
Study Completion:2039-03-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04664179

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. Age 18 years or older
  2. Willing and able to provide informed consent
  3. Able to understand and follow study procedures
  4. Stable medical condition
  1. Pregnancy or breastfeeding
  2. Severe psychiatric disorders
  3. Active substance abuse
  4. Unstable medical conditions
  5. Inability to comply with study requirements

Contacts and Locations

Study Contact

Bilal Omer, MD
CONTACT
832-824-6855
bomer@bcm.edu

Principal Investigator

Bilal Omer, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Bilal Omer, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-31
Study Completion Date2039-03-30

Study Record Updates

Study Start Date2022-10-31
Study Completion Date2039-03-30

Terms related to this study

Keywords Provided by Researchers

  • non-Hodgkin's Lymphoma
  • EBV (associated)-T/NK-lymphoproliferative disease
  • EBV SPECIFIC T-LYMPHOCYTES
  • EBV
  • Hodgkin's Lymphoma
  • lymphoma relapse

Additional Relevant MeSH Terms

  • EBV-Related Hodgkin Lymphoma
  • EBV-Related Lymphoproliferative Disorder
  • EBV Related Non-Hodgkin's Lymphoma