ATLCAR.CD30.CCR4 for CD30+ HL ATLCAR.CD30.CCR4 Cells
Hodgkin Lymphoma, Relapse, Refractory
About this trial
This is an interventional treatment trial for Hodgkin Lymphoma focused on measuring cellular therapy, CD30+
Eligibility Criteria
During the period of cell procurement and lymphodepletion, subjects will be eligible to receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests. Eligibility must be maintained up until the subject is procured, receives lymphodepletion, or receives treatment for the subject to be considered eligible to proceed with the specific phase of the study. Inclusion Criteria: Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study. As these criteria are unchanging they will be evaluated at the time of initial enrollment and not continuously throughout the study. Written informed consent and HIPAA authorization for release of personal health information explained to, understood by, and signed by the subject or legally authorized representative. Age ≥ 18 years at the time of consent. Karnofsky score of > 60% The subject must have a diagnosis of Classical Hodgkin Lymphoma according to World Health Organization criteria. Exclusion Criteria: Subjects had major surgery within 28 days. Subject received investigational agents or tumor vaccines within 3 weeks. Subject received chemotherapy or radiation therapy within the previous 3 weeks.
Sites / Locations
- Lineberger Comprehensive Cancer Center
Arms of the Study
Arm 1
Experimental
ATLCAR.CD30
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