RecruitingPhase 1NCT04664179

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

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


Sponsor

Baylor College of Medicine

Enrollment

52 participants

Start Date

Oct 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This trial tests T-lymphocytes (immune cells) grown to specifically target the Epstein-Barr virus (EBV) in patients with EBV-positive lymphoma — a type of lymphoma in which the cancer is driven in part by EBV infection. The immune cells are collected from the patient and trained to attack EBV-infected cancer cells. **You may be eligible if...** - You have EBV-positive Hodgkin's lymphoma, non-Hodgkin's lymphoma, or EBV-associated T/NK-lymphoproliferative disease - Your lymphoma has relapsed, is persisting despite treatment, or cannot be treated with standard immunosuppressive chemotherapy - You weigh at least 10 kg - Adequate liver, kidney, and blood function at time of treatment - Your oxygen level is above 90% on room air - Your activity level (Karnofsky/Lansky score) is at least 50% **You may NOT be eligible if...** - You are pregnant or breastfeeding (a pregnancy test is not required at the time of initial cell collection, but pregnancy is a contraindication at later stages) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALDose Level 1A: 2 x 10^7 cells/m2

2 x 10\^7 cells/m2

BIOLOGICALDose Level 2A: 6 x 10^7 cells/m2

6 x 10\^7 cells/m2

BIOLOGICALDose Level 2B: 6 x 10^7 cells/m2

6 x 10\^7 cells/m2

BIOLOGICALDose Level 3B: 2 x 10^8 cells/m2

2 x 10\^8 cells/m2

BIOLOGICALDose Level 3A: 2 x 10^8 cells/m2

2 x 10\^8 cells/m2


Locations(2)

Houston Methodist Hospital

Houston, Texas, United States

Texas Children's Hospital

Houston, Texas, United States

View Full Details on ClinicalTrials.gov

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NCT04664179