Status:
ACTIVE_NOT_RECRUITING
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma
Lead Sponsor:
UNC Lineberger Comprehensive Cancer Center
Collaborating Sponsors:
American Society of Clinical Oncology
Conditions:
Relapsed Hodgkin Lymphoma
Refractory Hodgkin Lymphoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 pro...
Detailed Description
In this study, investigators will enroll subjects with relapsed/refractory cHL being treated with anti-PD-1 therapy. The study will examine the treatment of relapsed/refractory cHL in this population ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
September 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 7 2037
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04134325
Start Date
September 1 2019
End Date
July 7 2037
Last Update
April 16 2025
Active Locations (1)
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1
Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill, North Carolina, United States, 27599