Allogeneic CD30 Chimeric Antigen Receptor Epstein-Barr Virus-Specific T Lymphocytes in Relapsed or Refractory CD30-Positive Lymphomas
Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type, Classical Hodgkin Lymphoma
About this trial
This is an interventional treatment trial for Extranodal Natural Killer/T-Cell Lymphoma, Nasal Type focused on measuring CD30-Positive Lymphoma, Hodgkin lymphoma, Non-Hodgkin lymphoma, CD30 CAR
Eligibility Criteria
Inclusion Criteria:
Diagnosis and clinical course falling into one of the following categories:
- Hodgkin lymphoma
- Aggressive non-Hodgkin lymphoma
- ALK-negative anaplastic T cell lymphoma or other peripheral T-cell lymphoma
- ALK-positive anaplastic T cell lymphoma
- CD30-positive tumor as assayed in a CLIA certified Pathology Laboratory.
- Age 12 to 75.
- Bilirubin 2 times (or 3 times if the patient has Gilbert syndrome) or less than the upper limit of normal.
- AST 3 times or less than the upper limit of normal.
- Estimated GFR > 70 mL/min.
- Pulse oximetry of > 90% on room air
- EKG shows no significant arrhythmias
- Karnofsky or Lansky score of > 60%.
- Available allogeneic T cells with ≥15% expression of CD30CAR determined by flow-cytometry.
- Recovered from all acute non-hematologic toxic effects of all prior chemotherapy.
- 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.
- 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:
- Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
- Received CD30 antibody-based therapy within the previous 4 weeks.
- History of hypersensitivity reactions to murine protein-containing products.
- Pregnant or lactating.
- Tumor in a location where enlargement could cause airway obstruction.
- Current use of systemic corticosteroids at a dose equivalent to higher than 10 mg/day of prednisone.
- Active significant, uncontrolled bacterial, viral or fungal infection.
- Symptomatic cardiac disease (NYHA Class III or IV disease).
Sites / Locations
- Houston Methodist Hospital
- Texas Children's Hospital
Arms of the Study
Arm 1
Experimental
Treatment Phase
Three dose levels will be evaluated based on safety data from our current study of CD30 CAR T cells. Cohorts of three to six patients will be enrolled at each dose level The dose is based on the number of CD.30 CAR-EBVT-expressing cells administered. The total number of dose levels evaluated will depend upon toxicities experienced. Dose level cohorts will be numbered sequentially. Dose Level 1: 1 × 10^8 CD30.CAR-EBVST cells Dose Level 2: 4 × 10^8 CD30.CAR-EBVST cells Dose Level 3: 1 × 10^9 CD30.CAR-EBVST cells