Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
University of Pennsylvania
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female subjects with HL with no available curative treatment options (such as autologous SCT) who have a limited prognosis (several months to \< 2 year survival) with currently available therapies will be enrolled.
i. HL with biopsy-proven relapse or refractory disease who are unresponsive to or intolerant of at least one line of standard salvage therapy ii. Patients must have evaluable disease by radiologic imaging (FDG PET/CT or PET/MRI) within 42 days of enrollment; evaluable includes both assessable and/or measurable disease as defined by Cheson et al., 2007.
1. Have no active GVHD and require no immunosuppression
2. Are more than 6 months from transplant
Performance status (ECOG) 0 or 1.
Left Ventricular Ejection Fraction (LVEF) ≥ 40% as confirmed by ECHO/MUGA
Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and pulse oxygen \> 92% on room air
Written informed consent is given.
You may not be if
Pregnant or lactating women. The safety of this therapy on unborn children is not known. Female study participants of reproductive potential must have a negative serum pregnancy test at enrollment. A urine or serum pregnancy test will be performed within 72 hours before the first RNA CART19 infusion.
Uncontrolled active infection.
Active hepatitis B or hepatitis C infection.
Any uncontrolled active medical disorder that would preclude participation as outlined.
HIV infection.
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system
Patients with active CNS involvement by malignancy. Patients with prior CNS disease that has been effectively treated will be eligible providing treatment was \>4 weeks before enrollment
Patients in complete remission with no evidence of evaluable disease by radiologic imaging.
History of allergy to murine proteins.
History of allergy or hypersensitivity to study product excipients (human serum albumin, DMSO, and Dextran 40).
Anti-CD20 monoclonal antibody therapy within the last 3 months, or absence of circulating B cells.
Class III/IV cardiovascular disability according to the New York Heart Association Classification (see Appendix 1).
Clareo Health | CD19 Redirected Autologous T Cells for Hodgkin Lymphoma
