A Prospective Pilot Study Assessing the Immunomodulatory Effect and Clinical Activity of Programmed Cell Death Protein 1 Inhibition Following CD30 Directed Chimeric Antigen Receptor T Cell Therapy in Relapsed/Refractory Classical Hodgkin Lymphoma

LCCC1852-ATL

LCCC1852-ATL is a prospective 2-arm study designed to determine if chimeric antigen receptor T (CAR-T) cells result in immunomodulation which can be subsequently exploited by programmed cell death protein 1 (PD-1) antibodies to achieve clinical responses in subjects with relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).

2019-09-01

2025-04-01

2037-07-07

Recruiting

Early phase I

20

Inclusion Criteria for Arm 1: Relapse After Prior CD 30 CAR-T Therapy * 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. Inclusion Criteria for Arm 2: Relapse with no Prior CD 30 CAR-T Therapy * 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. Exclusion Criteria for Arm 1: Relapse After Prior CD 30 CAR-T Therapy * Subject has received anti-CD30 CAR-T therapy within the previous 6 weeks. * Subject has known active infection with HIV, HTLV, HBV, HCV or any active, uncontrolled infection or sepsis. * Subject has received chemotherapy or anti-PD-1 therapy following CD30 CAR-T cell product administration. * 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. * Subject is currently using systemic corticosteroids at doses ≥10 mg prednisone daily or its equivalent, or other immunosuppressive medications. Exclusion Criteria for Arm 2: Relapse with no Prior CD 30 CAR-T Therapy * 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.

{'studyType': 'INTERVENTIONAL', 'phases': ['EARLY_PHASE1'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}

2024-04-23