A Phase 1 Study Evaluating the Safety and Activity of Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes (CD30.CAR-EBVSTs) in Patients With Relapsed or Refractory CD30-Positive Lymphomas

Description

This study involved patients that have a cancer called diffuse large B cell lymphoma (DLBCL), NK and T cell lymphomas (NK/TL) or classical Hodgkin lymphoma (cHL) (hereafter these 3 diseases will be referred to as lymphoma). Patients lymphoma has come back or not gone away after treatment. Because there is no standard treatment for the patients cancer at this time or because the currently used treatments do not work fully in all cases, the patients are being asked to volunteer in this research study. In this study the investigators want to test a type of T cell made from a normal donor. The T cells the investigators will use are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are cells that the investigators have trained in the laboratory to recognize a EBV which is the virus that causes mono or kissing disease. Some patients with lymphoma have EBV in their cancer cells. Researchers have given T cell lines from normal donor EBVSTs to lymphoma patients who have EBV in thei

Trial Eligibility

Inclusion Criteria: 1. Diagnosis and clinical course falling into one of the following categories: 1. Hodgkin lymphoma 2. Aggressive non-Hodgkin lymphoma 3. ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma 4. ALK-positive anaplastic T cell lymphoma 2. CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory. 3. Age 12 to 75. 4. Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal. 5. AST 3 times or less than the upper limit of normal. 6. Estimated GFR \> 70 mL/min. 7. Pulse oximetry of \> 90% on room air 8. EKG shows no significant arrhythmias 9. Karnofsky or Lansky score of \> 60%. 10. Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry. 11. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy. 12. 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. 13. Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given a copy of the informed consent form. Exclusion Criteria: 1. Received an investigational cell therapy or vaccine within the past 6 weeks. 2. Received an investigational small molecule drug within the past 2 weeks. 3. Received CD30 antibody-based therapy within the previous 4 weeks. 4. Received gemcitabine-containing chemotherapy within the previous 12 weeks 5. History of hypersensitivity reactions to murine protein-containing products. 6. Pregnant or lactating. 7. Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion). 8. Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone. 9. Active significant, uncontrolled bacterial, viral or fungal infection. 10. Symptomatic cardiac disease (NYHA Class III or IV disease).

Study Info

Interventions

Locations Recruiting

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