Genetically Engineered Cells (ATLCAR.CD30 T Cells) for the Treatment of Relapsed or Refractory CD30 Positive Peripheral T Cell Lymphoma

Inclusion Criteria

• Written informed consent to undergo cell procurement and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject or legally authorized representative
• Age >= 18 years at the time of consent
• Karnofsky score of > 60%
• Histological or cytological evidence/confirmation of CD30+ peripheral T-cell lymphoma per the 2017 World Health Organization Classification of Hematopoietic and Lymphoid Tissues
• CD30+ disease determined via archival tissue after the subject’s most recent anti-CD30 therapy prior to ATLCAR.CD30 (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with the first infusion of ATLCAR.CD30 cells). NOTE: CD30+ disease requires documented CD30 expression by immunohistochemistry based on the institutional hematopathology standard
• Any subject with relapsed or refractory lymphoma after at least one prior line of therapy as long as prior therapy included brentuximab vedotin (unless they were not candidates for brentuximab vedotin)
• Subjects relapsed after allogeneic stem cell transplant are eligible provided the patient is ≥ 180 days from transplant, not on immunosuppressive therapy to treat/prevent graft-versus-host disease, and has no evidence of active graft-versus-host disease
• Subjects with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial
• Female subjects of childbearing potential must have a negative serum pregnancy test within 72 hours prior to cell procurement. Note: Females are considered of childbearing potential unless they are surgically sterile (have undergone a hysterectomy, bilateral tubal ligation, or bilateral oophorectomy) or they are naturally postmenopausal for at least 12 consecutive months. Documentation of postmenopausal status must be provided. Female subjects of childbearing potential must not be lactating (Note: Breast milk cannot be stored for future use while the mother is being treated on study)
• Female subjects of childbearing potential must be willing to abstain from heterosexual activity or to use 2 forms of effective methods of contraception from the time of informed consent until 6 months after study treatment discontinuation. The two contraception methods can be comprised of two barrier methods, or a barrier method plus a hormonal method or an intrauterine device that meets < 1% failure rate for protection from pregnancy in the product label. Women of childbearing potential will also be instructed to tell their male partners to use a condom
• Subject is willing and able to comply with study procedures based on the judgement of the investigator or protocol designee
• Must not be using systemic corticosteroids at doses ≥ 10 mg prednisone daily or its equivalent; those receiving < 10 mg daily may be enrolled at discretion of investigator. Inhaled steroids are allowed
• Must not have an active infection with HIV or hepatitis C virus (HCV) (tests can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Note: To meet eligibility subjects are required to be negative for HIV antibody and negative for HCV antibody or HCV viral load
• Must not be positive for hepatitis B surface antigen (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells). Subjects who are hepatitis B surface antigen negative but hepatitis B core antibody positive must have their hepatitis B viral load checked. Subjects are not eligible if their viral load is positive at baseline. Subjects who are core antibody positive and viral load negative at baseline will be considered eligible
• Subject has life expectancy ≥ 6 weeks
• Hemoglobin ≥ 8.0 g/dL (within 7 days of cell procurement) (transfusion prior to procurement are allowed)
• Total bilirubin ≤ 2 x upper limit of normal (ULN), unless attributed to Gilbert's syndrome (within 7 days of cell procurement)
• Aspartate aminotransferase (AST) ≤ 3 x ULN (within 7 days of cell procurement)
• Alanine aminotransferase ≤ 3 x ULN (within 7 days of cell procurement)
• Creatinine ≤ 2 x ULN (within 7 days of cell procurement)
• Pulse oximetry of > 90% on room air (within 7 days of cell procurement)
• Subjects must have active disease by imaging assessment within 90 days prior to procurement