Tumor Associated Antigen Specific T Cells (TAA-T) With PD1 Inhibitor for Lymphoma

A regiszterben nem jelölt feltételek

• Disease Specific Inclusion Criteria
• Group A (patients with measurable disease) Relapsed/Refractory Hodgkin Lymphoma (HL) and Diffuse Large B cell Lymphoma (DLBCL) DLBCL
• Patients who have failed at least 2 lines of prior therapy with a failed attempt at both an autologous stem cell transplant and chimeric antigen receptor T cell therapy.
• Patients who are deemed autologous stem cell transplant ineligible and have failed only one line of prior therapy.
• Systemic therapies to treat prior indolent lymphomas count towards previous DLBCL lines of therapy unless the treatment was anti-CD20 antibody monotherapy.
  • HL
• Rel/ref HL failing more than or equal to 1 salvage regimens, including prior Brentuximab Vedotin (BV)
• Rel/ref after autologous HSCT
  • Group B (consolidation after auto-HSCT for patients at high risk for relapse) DLBCL
• Patients with < CMR/CR (by PET/CT) with initial treatment regimen
• Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy
• Patients with <CMR/CR (by PET/CT) prior to autologous HSCT
• Patients requiring >1 salvage regimen prior to autologous HSCT HL
• Patients with relapse <12 months from diagnosis or <6 months from completion of initial therapy
• Patients with <CMR/CR (by PET/CT) prior to autologous HSCT
• Patients requiring >1 salvage regimen prior to autologous HSCT
  • Recipient Inclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):
• Age >12 years
• Karnofsky/Lansky score of more than or equal to 50 (see appendix C).
• ALC > 600
• Patients receiving Granulocyte colony-stimulating factor (G-CSF) are recommended a washout period of a minimum of two weeks before procurement
• Agree to use contraceptive measures during study protocol participation (when age appropriate)
• Patient or parent/guardian capable of providing informed consent
  • Recipient Exclusion Criteria for Initial and Subsequent Procurements (TAA-T Cell Generation):
• Prior allogeneic BMT
• Prior solid organ transplant
• Patient who has received ATG, Campath or other immunosuppressive T cell monoclonal antibodies within 28 days of screening for enrollment
• Patient with uncontrolled infections
• Patient with active HIV
• Pregnancy or lactating
• Failure to meet institutional guidelines for treatment with Nivolumab
  • Recipient Inclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:
• Age >12 years
• Patient has received at least 8 weeks of Nivolumab
• Patients with Grade 1 toxicities attributed to Nivolumab will be eligible at the discretion of the PI. Toxicities include but not limited to: laboratory abnormalities in thyroid function tests suggestive of hypothyroidism, thyroiditis or thyroid dysfunction adequately managed with thyroid hormone replacement, or abnormalities in amylase, lipase
• Steroids less than 0.5 mg/kg/day prednisone or equivalent
• Karnofsky/Lansky score of more than or equal to 50
• Pulse oximetry of > 90% on room air
• Bilirubin less than or equal to 2.5 mg/dL, AST/ALT less than or equal to 5x upper limit of normal, serum creatinine < 1.0 or 2x the upper limit of normal (whichever is higher)
• Absolute neutrophil count > 250/µL (may be supported with GCSF)
• Agree to use contraceptive measures during study protocol participation (when age appropriate)
• Patient or parent/guardian capable of providing informed consent
  • Recipient Exclusion Criteria for Initial and Subsequent TAA-T Cell Infusions:
• Investigational therapies within 28 days prior to screening for enrollment
• Uncontrolled infections
• Patient with ≥ grade 1 or symptomatic non-hematologic toxicities from prior therapies