Last updated on February 2019

Administration of T Lymphocytes for Prevention of Relapse of Lymphomas


Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Disorder of immune system | Cancer | Lymphoproliferative Disorder | Lymphadenopathy | Immunoproliferative disease | Hodgkin's Disease | Lymphoma | Neoplasms by Histologic Type
  • Age: Between 3 - 100 Years
  • Gender: Male or Female

Inclusion Criteria:

  • Informed consent explained to, understood by and signed by patient/guardian; patient/guardian given copy of informed consent.
  • 3 to 17 years of age for pediatric patients, 18 years of age for adults; NOTE: children will not be allowed to enroll in a dose cohort until a minimum of 2 adult subjects are enrolled and complete their DLT assessment follow-up at that dose level
  • Diagnosis of recurrent HL with a treatment plan that will include high dose chemotherapy with/without total body irradiation and autologous cell transplantation
  • NHL patients with ALK negative CD30+ anaplastic large-cell lymphomas, CD30+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD30+ high-risk DLBCL, CD30+ cutaneous T cell lymphoma, or CD30+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study
  • CD30+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD30 cells); NOTE: CD30 + disease is defined as requiring documentation of CD30 expression by immunohistochemistry based on the institutional hematopathology standard.
  • Evidence of adequate organ function as defined by:
  • The following is required prior to procurement (NOTE: labs do not need to be redrawn if they have already been performed as part of SOC pre-transplant work-up; Subject must be eligible to receive ASCT)
  • Hgb 8.0g/dL
  • Bilirubin 1.5 times the upper limit of normal (ULN)
  • AST 3 times ULN
  • Serum creatinine 1.5 times ULN
  • Cardiac and pulmonary function that is adequate for ASCT
  • The following is required prior to infusion of ATLCAR.CD30 cells:
  • Absolute neutrophil count (ANC) 500 cells/mm3 for 3 consecutive days; Note: ANC may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day AND
  • Platelet count 25,000 cells/mm3 without transfusion over preceding 5 days Note: Platelets may be measured at the beginning and the end of a time frame expanding at least 5 days and does not need to be evaluated on each individual day AND
  • Hg 8g/dL without transfusion support over preceding 5 days Note: Hg may be measured at the beginning and the end of a time frame expanding at least 3 days and does not need to be evaluated on each individual day
  • Bilirubin 1.5 times the upper limit of normal (ULN)
  • AST 3 times ULN
  • Serum creatinine 1.5 times ULN
  • Pulse oximetry of > 90% on room air
  • Imaging results from within 60 days prior to transplant (used as baseline measure for documentation of disease status). Note: Results may be obtained at a time point greater than 30 days from transplant if obtained per the patient's standard of care and with prior sponsor approval.
  • Negative serum pregnancy test within 72 hours prior to procurement and again 72 hours prior to infusion
  • Karnofsky or Lansky score of > 60%
  • Considered at high risk for relapse as defined by: The presence of 1 of the following: failure to achieve CR post initial treatment; relapsed disease with an initial remission duration of <12 months; or extranodal involvement at the start of pre-transplant salvage therapy
  • Subjects must have autologous transduced activated T cells that meet the Certificate of Analysis (CoA) acceptance criteria
  • Women of childbearing potential (WOCBP) should be willing to use 2 methods of birth control or be surgically sterile, or abstain from heterosexual activity for the course of the study, and for 6 months after the study is concluded. WOCBP are those who have not been surgically sterilized or have not been free from menses for > 1 year. The two birth control methods can be composed of: two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The male partner of WOCBP subjects enrolled into the trial should be instructed to use a condom by their female partner enrolled in the trial.

Exclusion Criteria:

  • Received any investigational agents or received any tumor vaccines within the previous six weeks prior to cell infusion.
  • Received anti-CD30 antibody-based therapy within the previous 4 weeks prior to cell infusion
  • 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 doses 10mg/day prednisone or its equivalent; those receiving <10mg/day may be enrolled at discretion of investigator
  • Active infection with HIV, HTLV, HBV, HCV (can be pending at the time of cell procurement; only those samples confirming lack of active infection will be used to generate transduced cells) . Active infection is defined as not being well controlled on therapy (Note: To meet eligibility subjects are required to be negative for HIV antibody or HIV viral load, negative for HTLV1 and 2 antibody, negative for Hepatitis B surface antigen, or negative for HCV antibody or HCV viral load).

Recruitment Status: Open


Brief Description Eligibility Contact Research Team


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