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

2019-10-28 13:57:26 | BioPortfolio

Summary

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).

Description

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.

Study Design

Conditions

Relapsed Hodgkin Lymphoma

Intervention

Nivolumab, Pembrolizumab

Location

Lineberger Comprehensive Cancer Center at University of North Carolina
Chapel Hill
North Carolina
United States
27599

Status

Recruiting

Source

UNC Lineberger Comprehensive Cancer Center

Results (where available)

View Results

Links

Published on BioPortfolio: 2019-10-28T13:57:26-0400

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Medical and Biotech [MESH] Definitions

Two or more distinct types of malignant lymphoid tumors occurring within a single organ or tissue at the same time. It may contain different types of non-Hodgkin lymphoma cells or both Hodgkin and non-Hodgkin lymphoma cells.

A form of non-Hodgkin lymphoma having a usually diffuse pattern with both small and medium lymphocytes and small cleaved cells. It accounts for about 5% of adult non-Hodgkin lymphomas in the United States and Europe. The majority of mantle-cell lymphomas are associated with a t(11;14) translocation resulting in overexpression of the CYCLIN D1 gene (GENES, BCL-1).

Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.

Clinically benign, histologically malignant, recurrent cutaneous T-cell lymphoproliferative disorder characterized by an infiltration of large atypical cells surrounded by inflammatory cells. The atypical cells resemble REED-STERNBERG CELLS of HODGKIN DISEASE or the malignant cells of CUTANEOUS T-CELL LYMPHOMA. In some cases, lymphomatoid papulosis progresses to lymphomatous conditions including MYCOSIS FUNGOIDES; HODGKIN DISEASE; CUTANEOUS T-CELL LYMPHOMA; or ANAPLASTIC LARGE-CELL LYMPHOMA.

A systemic, large-cell, non-Hodgkin, malignant lymphoma characterized by cells with pleomorphic appearance and expressing the CD30 ANTIGEN. These so-called "hallmark" cells have lobulated and indented nuclei. This lymphoma is often mistaken for metastatic carcinoma and MALIGNANT HISTIOCYTOSIS.

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