Autologous IC-Nine, CD30 CAR, and Constitutive IL7R Expressing EBVST for CD30 Lymphoma (ANCILE-30)

Criteria the registry did not label

• Procurement Inclusion Criteria:
• Participants must meet the protocol-defined procurement eligibility criteria before collection of peripheral blood mononuclear cells for manufacture of the investigational product, including:
• Diagnosis of relapsed or refractory Hodgkin lymphoma or non-Hodgkin lymphoma.
• CD30 positive tumor (can be pending at this time) as assayed in a CLIA certified Pathology Laboratory.
• Age 16 to 75 years.
• Hemoglobin ≥7.0(may be transfused value).
• Karnofsky or Lansky score of \> 60%
• Informed consent explained to, understood by and signed by patient or guardian. Patient or guardian given copy of informed consent.
  • Procurement Exclusion Criteria:
• Active HIV or HTLV infection (testing may be pending at procurement).
• Active bacterial, fungal, or viral infection.
  • \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_
  • Treatment Inclusion Criteria:
  • Participants with a successfully manufactured product must continue to satisfy the protocol-defined treatment eligibility criteria before receiving study treatment, including:
• Diagnosis and clinical course falling into one of the following categories:
  • Hodgkin lymphoma
  • CD30+ aggressive B-cell lymphoma
  • ALK-negative anaplastic T cell lymphoma or other peripheral T- cell lymphoma
  • ALK-positive anaplastic T cell lymphoma
• CD30 expression confirmed in a CLIA-certified laboratory. Recovered from all acute non-hematologic toxic effects of all prior chemotherapy
• Age 16 to 75 years.
• Bilirubin ≤ 2 times the upper limit of normal (except for Gilbert syndrome, where the criteria will be Bilirubin ≤ 3 times the upper limit of normal).
• AST ˂ 3 times the upper limit of normal
• Estimated GFR \> 50 mL/min
• Pulse oximetry of \> 90% on room air
• Karnofsky or Lansky score of \> 60%
• Sexually active patients must be willing to utilize one of the more effective birth control methods during the study and for 6 months after study is concluded. Male partner should use a condom
• Informed consent explained to, understood by and signed by patient/guardian. Patient/Guardian given copy of informed consent.
  • Treatment Exclusion Criteria:
• Received an investigational cell therapy or vaccine within the past 6 weeks.
• Received an investigational small molecule within the past 2 weeks.
• Received anti-CD30 antibody-based therapy within the previous 4 weeks.
• History of hypersensitivity reactions to murine protein-containing products
• Pregnancy or breastfeeding.
• Tumor in a location where enlargement could cause airway obstruction (determined at the investigators' discretion)
• 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).