This phase I trial finds out the best dose and side effects of donor CD30.CAR-EBVST in treating patients with CD30 positive lymphomas that have come back (recurrent) or have not responded to treatment (refractory). CD30.CAR-EBVST are immune system cells called T-cells and antibodies that are manipulated to find cancer cells that carry a marker called CD30. Antibodies are proteins that protect the body from diseases caused by bacteria, viruses and other foreign substances by binding to them to stop them from causing bad effects. T cells are special infection-fighting white blood cells that can kill other cells including tumor cells or cells that are infected with bacteria and viruses. An antibody called anti-CD30 has been used to treat lymphoma but has not cured many of the patients. In this study, the anti-CD30 antibody has been changed so that instead of floating free in the blood it is now joined to the T cells through a process called gene transfer. The resulting cells are called CD30.CAR T cells. The T cells used are called Epstein Barr virus (EBV) specific T cells (EBVSTs) and are normal cells from a donor that have been trained in the laboratory to recognize a EBV which is the virus that causes mononucleosis or glandular fever (mono or kissing disease). Giving CD30.CAR-EBVST after chemotherapy may work better in treating relapsed or refractory CD30 positive lymphomas.
Additional locations may be listed on ClinicalTrials.gov for NCT04288726.
Locations matching your search criteria
United States
Texas
Houston
Center for Cell and Gene TherapyStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
Texas Children's HospitalStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterStatus: Active
Contact: Carlos Almeida Ramos
Phone: 832-824-4817
PRIMARY OBJECTIVE:
I. To evaluate the safety of one dose of allogeneic Anti-CD30 CAR-Epstein-Barr virus-specific T-lymphocytes (CD30.CAR-EBVSTs) in patients with CD30+ refractory/relapsed Hodgkin lymphoma (HL) or non-Hodgkin lymphoma (NHL) after lymphodepleting chemotherapy.
SECONDARY OBJECTIVES:
I. To measure the preliminary antitumor effect of allogeneic CD30.CAR-EBVST cells in this patient population, including:
Ia. Objective response (OR) rate (ORR).
Ib. Duration of response (DR).
Ic. Stable disease (SD) rate.
Id. Duration of SD.
Ie. Progression free survival (PFS).
EXPLORATORY OBJECTIVES:
I. To measure expansion and persistence of allogeneic CD30.CAR-EBVST cells (in blood).
II. To evaluate association between immunological parameters (in blood), safety, and clinical response.
OUTLINE: This is a dose-escalation study of CD30.CAR-EBVST cells.
Patients receive cyclophosphamide intravenously (IV) over 1 hour and fludarabine IV over 30 minutes of clofarabine IV over 1 hour once daily (QD) for 3 doses finishing at least 48 hours before T cell infusion, but no later than 2 weeks prior to infusion of the cells. Patients then receive CD30.CAR-EBVST cells IV over 1-10 minutes on day 0. Patients may receive up to 3 additional cycles in the absence of disease progression or unacceptable toxicity. Patients undergo tumor biopsy on study and computed tomography (CT) scan/ magnetic resonance imaging (MRI)/ position emission tomography (PET) scan and blood sample collection throughout the study.
After completion of study treatment, patients are followed up at weeks 1-6, 8 weeks, 3, 6, 9, and 12 months, every 6 months for 4 years, and then annually for up to 15 years.
Lead OrganizationBaylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
Principal InvestigatorCarlos Almeida Ramos