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LCCC1852-ATL is a prospective pilot 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).
In this study, investigators will enroll 10 subjects with relapsed/refractory cHL who have previously progressed on anti-PD-1 therapy, have received a CD30 CAR-T cell therapy and have evidence of progression. Subjects will be offered anti-PD-1 therapy (nivolumab or pembrolizumab, at the discretion of treating oncologist), as per standard of care in r/r HL. Peripheral blood samples will be collected from subjects after consent has been obtained at the time of progression following CD30 CAR-T cell therapy as well as at Day 21 and Day 42 of anti-PD-1 therapy. Investigators will also have access to peripheral blood samples prior to CD30 CAR-T cell therapy, acquired during a prior clinical study. Peripheral blood samples will be immunophenotyped by mass cytometry and T-cell receptor (TCR) sequencing will be pursued to establish expansion of clinically relevant T-cell clones.
The primary objective of this study is to measure the ability of anti-PD-1 therapy to rescue peripheral T-cell exhaustion after progression following CD30 CAR-T cell therapy. The secondary objectives will be to measure the immunomodulatory effect of CD30 CAR-T cell therapy as well as estimate the objective response rate (ORR) and progression free survival (PFS) of anti-PD-1 therapy after progression on CD30 CAR-T cell therapy.
Preliminary data from subjects treated with anti-PD-1 therapy after progression following CD30 CAR-T cell therapy has suggested surprisingly robust clinical responses to anti-PD-1 therapy. Therefore, this pilot study is an important advancement in our understanding of both immunomodulation after CD30 CAR-T cell therapy as well as clinical response to anti-PD-1 therapy. This study will serve as a baseline for clinical response and immunomodulation for future clinical trials evaluating the combination of anti-PD-1 therapy and CD30 CAR-T cell therapy.
Relapsed Hodgkin Lymphoma
Lineberger Comprehensive Cancer Center at University of North Carolina
UNC Lineberger Comprehensive Cancer Center
Published on BioPortfolio: 2019-10-28T13:57:26-0400
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