Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma (NCT04134325) | Clinical Trial Compass
Active — Not RecruitingEarly Phase 1
Study of PD-1 Inhibitors After CD30.CAR T Cell Therapy in Relapsed/Refractory Hodgkin Lymphoma
United States10 participantsStarted 2019-09-01
Plain-language 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 protein 1 (PD-1) antibodies to achieve clinical responses in subjects with relapsed/refractory (r/r) classical Hodgkin Lymphoma (cHL).
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …
What they're measuring
1
Objective response, defined as complete response (CR) or partial response (PR) at 12 weeks after initiating anti-PD-1 therapy