EBV CTLs Expressing CD30 Chimeric Receptors For CD 30+ Lymphoma

Korábbi kezelés

• Received rituximab within 4 months of blood collection for LCL initiation (unless circulating CD19+ B are =/>2%)
  • TREATMENT Exclusion Criteria:
• Currently receiving any investigational agents or received any tumor vaccines within the previous six weeks.
• Received anti-CD30 antibody-based therapy within the previous 6 weeks.
• Current use of systemic corticosteroids.

Más betegség

• Active infection with HIV, HTLV, HBV, HCV (can be pending at this time).
• History of hypersensitivity reactions to murine protein-containing products.

Egyéb

• PROCUREMENT Exclusion Criteria:
• Pregnant or lactating.
• Tumor in a location where enlargement could cause airway obstruction.

• PROCUREMENT Inclusion Criteria:
• Referred patients will initially be consented for procurement of blood for generation of the transduced CTL Line. Eligibility criteria at this stage include:
• Diagnosis of recurrent HL or NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory HL or NHL with a treatment plan that will include high dose therapy and stem cell transplantation
• CD30 positive tumor (can be pending at this time)
• EBV seropositivity (can be pending at this time)
• Hgb > 8.0
• Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.
  • TREAMENT Inclusion Criteria: Patients must meet the following eligibility criteria to be included for treatment:
• Diagnosis - CD30+ HL or CD30+ NHL
• During the dose escalation phase: only adult patients (age 18 and older) with active disease failing standard therapy
• After dose escalation: any patient (children or adults) with relapsed CD30+ HL or CD30+ NHL or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD30+ HL or CD30+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation.
• CD30 positive tumor
• EBV seropositivity.
• Recovered from acute toxic effects of all prior chemotherapy at least one week and 30 days from prior chemotherapy before entering this study.
• Bilirubin 1.5 times or less than upper limit of normal.
• AST 3 times or less than upper limit of normal.
• Serum creatinine 1.5 times or less than upper limit of normal.
• Pulse oximetry of > 90% on room air
• Karnofsky or Lansky score of > 60%.
• Available autologous transduced EBV-specific cytotoxic T lymphocytes with 15% or more expression of CD30CAR determined by flow-cytometry.
• Adequate pulmonary function with FEV1, FVC and DLCO 50% or greater of expected corrected for hemoglobin. Exceptions may be allowed for patients with pulmonary involvement after discussing with PI.
• 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.
• Patients or legal guardians must sign an informed consent indicating that they are aware this is a research study and have been told of its possible benefits and toxic side effects. Patients or their guardians will be given a copy of the consent form.