ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
Status:
Not yet recruiting
Trial end date:
2031-07-01
Target enrollment:
Participant gender:
Summary
Despite the progress in the therapy, Hodgkin's Lymphoma (HL) remains fatal for more than 15%
of patients. Even in patients who are cured, the morbidity of therapy is substantial and
long-lasting. New therapeutic agents are required therefore not only to further reduce
mortality but also to alleviate morbidity.
The majority of HL express the CD30 antigens. CD30 expression is routinely used for the
diagnosis of HL. Preclinical observations support CD30 as a viable target of CAR-T therapy.
This phase Ib/II study was conducted based on these observations.
The purpose of this study is to determine the tolerability of ATLCAR.CD30.CCR4 cells in
subjects with Hodgkin's Lymphoma and identify a recommended dose for further.
This is a single-center, open-label phase Ib/II trial that uses a 3+3 design to identify a
recommended phase 2 dose (RP2D) of ATLCAR.CD30.CCR4 cells in Hodgkin's Lymphoma. The phase II
portion is designed to determine the PFS of ATLCAR.CD30.CCR4 in Hodgkin's Lymphoma.
Subjects will be enrolled on 1 of 3 dose levels as determined by a 3+3 design. Up to 25
evaluable subjects may then be enrolled in the phase II portion of the study. Subjects may
have cells procured to manufacture the ATLCAR.CD30.CCR4 cells if they meet eligibility for
procurement. During the time period necessary to manufacture the ATLCAR.CD30.CCR4 cells,
Subjects will be allowed to receive standard-of-care bridging therapy at the discretion of
their local oncologist. Prior to cell infusion, subjects will undergo additional eligibility
evaluations, and then if eligible, will undergo lymphodepletion followed by cell infusion
2-14 days later. Subjects will then be followed for 15 years as is required for studies
involving gene transfer experiments.