Cytotoxic T-Lymphocytes for EBV-positive Lymphoma, GRALE

Launched by BAYLOR COLLEGE OF MEDICINE · Mar 15, 2012

Keywords

ClinConnect Summary

This clinical trial, called GRALE, is studying a new treatment for patients with certain types of lymphoma, including Hodgkin's disease and non-Hodgkin's lymphoma, that are linked to a virus called Epstein Barr Virus (EBV). The researchers want to see if specially trained white blood cells, known as GRALE T cells, can help fight the cancer by targeting and destroying the EBV-infected cells. This study is important because it aims to find the safest and most effective dose of these GRALE T cells, which have shown promise in previous trials.

To be eligible for this trial, patients need to have EBV-positive lymphoma or related conditions and be at least 12 kg in weight. They should also have a life expectancy of at least six weeks and meet certain health criteria. Participants will receive GRALE T cells and will be monitored for any side effects and how well the treatment works. It's essential to understand that these GRALE T cells are experimental, meaning they are not yet approved by the FDA. If you or a loved one is interested in participating, please talk to your healthcare provider for more information.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria at time of Procurement
• • 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma, (regardless of the histological subtype) or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV) who may subsequently be eligible for the treatment component
• • 2. EBV positive tumor (can be pending at this time)
• • 3. Weighs at least 12kg
• • 4. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
• • Inclusion Criteria at time of Infusion
• • 1. Any patient, regardless of age or sex, with EBV-positive Hodgkin's or non-Hodgkin's Lymphoma (regardless of histologic subtype), or EBV (associated)-T/NK-lymphoproliferative disease or Severe Chronic Active EBV (CAEBV)\* and
• • In second or subsequent relapse (or first relapse or with active disease if immunosuppressive chemotherapy contraindicated or multiply relapsed patients in remission who have a high risk of relapse)\*\* OR any patient with primary disease or in first remission if immunosuppressive chemotherapy is contraindicated, e.g. patients who develop Hodgkin disease after solid organ transplantation or if the Lymphoma is a second malignancy e.g. a Richter's transformation of CLL. (Group A)
• • OR
• • In remission or with minimal residual disease status after autologous or syngeneic SCT. (Group B)
• • 2. EBV positive tumor
• • 3. Patients with bilirubin less than or equal to 3x upper limit of normal, AST less than or equal 5x upper limit of normal, and hemoglobin greater than or equal to 7.0 (may be a transfused value).
• • 4. Patients with a creatinine less than or equal to 2x upper limit of normal for age
• • 5. Pulse oximetry of \> 90% on room air
• • 6. Patients should have been off other investigational therapy for 4 weeks prior to entry in this study. PD1/PDL inhibitors will be allowed if medically indicated.
• • 7. Patients with a Karnofsky/Lansky score of greater than or equal to 50
• • 8. Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after the study is concluded. The male partner should use a condom.
• • 9. Informed consent explained to, understood and signed by patient/guardian. Patient/guardian given copy of informed consent.
• • CAEBV is defined as patients with high EBV viral load in plasma or PBMC (\> 4000 genomes per ug PBMC DNA) and/or biopsy tissue positive for EBV
• • Patients with relapsed or refractory lymphoma that are eligible for a stem cell transplant will not be treated on this study as an alternative to transplant.
• • Exclusion Criteria at Time of Procurement
• • 1. Active infection with HIV, HTLV, HBV, HCV (can be pending at this time)
• • Exclusion Criteria at Time of Infusion
• • 1. Pregnant or lactating
• • 2. Severe intercurrent infection.
• • 3. Current use of systemic corticosteroids \> 0.5 mg/kg/day