Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma

Korábbi kezelés

• Subject has received anti-CD30 CAR-T therapy within the previous 6 weeks.
• Subject has received chemotherapy or anti-PD-1 therapy following CD30 CAR-T cell product administration.
• Subject is currently using systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent, or other immunosuppressive medications.
• Subject has received anti-CD30 CAR-T therapy
• Subject is currently using systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent, or other immunosuppressive medications.

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• Subject has known active infection with HIV, HTLV, HBV, HCV or any active, uncontrolled infection or sepsis.
• Subject has a known additional malignancy that is active and/or progressive requiring treatment; exceptions include basal cell or squamous cell skin cancer, in situ cervical or bladder cancer, or other cancer for which the subject has been disease-free for at least five years.

• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Age ≥18 years at the time of consent.
• Subject is planned to start on standard of care anti-PD-1 therapy per community standards of medical care by their treating oncologist.
• Subject has a diagnosis of relapsed/refractory classical Hodgkin lymphoma after at least three lines of prior therapy with clinical progression after either ATLCAR.CD30 and/or ATLCAR.CD30.CCR4. The CAR-T cell product may be either the UNC, Baylor or Tessa product.
• Subjects with prior allogeneic stem cell transplant will be eligible but will be counseled during consent regarding possible increased risk of graft versus host disease with anti-PD-1 therapy after allogeneic stem cell transplant.
• Subjects must have previously been treated with anti-PD-1 therapy (any anti-PD-1 therapy either standard of care or investigational) prior to receiving autologous CAR-T-cell therapy.
• Subject is willing to provide blood samples that are clinically necessary during anti-PD-1 therapy administered per community standards of medical care.
• Written informed consent obtained to participate in the study and HIPAA authorization for release of personal health information.
• Age ≥18 years at the time of consent.
• Subject is planned to start on standard of care anti-PD-1 therapy per community standards of medical care by their treating oncologist.
• Subject has a diagnosis of classical Hodgkin lymphoma.
• Subjects with prior allogeneic stem cell transplant will be eligible but will be counseled during consent regarding possible increased risk of graft versus host disease with anti-PD-1 therapy after allogeneic stem cell transplant.
• Subject is willing to provide blood samples that are clinically necessary during anti-PD-1 therapy administered per community standards of medical care.
• Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
• Subject is willing to consent to study-required blood draws.