EBV-Specific T-Cell Therapy for Lymphoma
(CILESTE Trial)
Trial Summary
What is the purpose of this trial?
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.
Will I have to stop taking my current medications?
The trial requires that you stop taking other investigational therapies at least 4 weeks before joining. If you are using systemic corticosteroids (like prednisone) at a dose higher than 0.5 mg/kg/day, you will need to stop those as well.
What data supports the effectiveness of the treatment C7R-EBV T cells for lymphoma?
Research shows that C7R-EBV T cells, which are specially modified immune cells, have been effective in controlling lymphoma in animal studies and have led to clinical trials for treating difficult cases of EBV-positive lymphoma. These cells are designed to last longer and work better against tumors, offering hope for patients with this type of cancer.12345
Is EBV-specific T-cell therapy safe for humans?
EBV-specific T-cell therapy has been used in over 250 patients with EBV-related diseases and has been shown to be safe, with no toxic effects attributed to the therapy. It has been used successfully to prevent and treat EBV-related lymphoma in transplant recipients without causing harmful side effects.23456
What makes the EBV-Specific T-Cell Therapy for Lymphoma unique compared to other treatments?
This treatment uses specially engineered T cells that specifically target the Epstein-Barr virus (EBV) present in lymphoma cells, offering a more precise approach than traditional therapies. It involves the adoptive transfer of EBV-specific cytotoxic T lymphocytes, which can restore or induce protective immunity against the virus, potentially leading to complete remission even in patients who have not responded to standard treatments.23578
Research Team
Bilal Omer, MD
Principal Investigator
Baylor College of Medicine
Eligibility Criteria
This trial is for individuals with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, or T/NK-lymphoproliferative disease that persists after treatment. Participants must have certain blood and organ function levels, weigh at least 10 kg, have a life expectancy of over 6 weeks, and not be on systemic steroids or pregnant.Inclusion Criteria
Exclusion Criteria
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Patients receive C7R EBV T cells, possibly with cyclophosphamide and fludarabine chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after treatment, with scheduled visits and disease evaluations
Optional Additional Dose
Eligible participants may receive an additional dose of C7R EBV T cells if disease has not worsened
Treatment Details
Interventions
- C7R-EBV T cells (CAR T-cell Therapy)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Baylor College of Medicine
Lead Sponsor
Texas Children's Hospital
Collaborator
National Cancer Institute (NCI)
Collaborator
The Methodist Hospital Research Institute
Collaborator