This phase II trial studies how well bridging therapy with loncastuximab tesirine and rituximab (lonca-R) works in treating patients that are undergoing standard of care (SOC) CD19 chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma that has come back after a period of improvement (relapsed) or that does not respond to treatment (refractory). CD19 CAR T-cell therapy is a treatment that uses T-cells that have been engineered to contain a CAR that specifically targets the CD19 antigen. Bridging therapy is often given before CAR T-cell therapy to help transition the patient to the CAR T-cell therapy or to maintain their health or status until they are a candidate for the CAR T-cell therapy. Loncastuximab tesirine is a monoclonal antibody, called loncastuximab, linked to a drug, called pyrrolobenzodiazepine (PBD). Loncastuximab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as CD19 receptors, and delivers PBD to kill them. Rituximab is a monoclonal antibody. It binds to a protein called CD20, which is found on B cells (a type of white blood cell) and some types of cancer cells. This may help the immune system kill cancer cells. Giving bridging therapy with lonca-R may be effective in treating patients undergoing SOC CD19 CAR T-cell therapy for relapsed/refractory (R/R) large B-cell lymphoma.
Additional locations may be listed on ClinicalTrials.gov for NCT06788964.
Locations matching your search criteria
United States
Utah
Salt Lake City
Huntsman Cancer Institute/University of UtahStatus: Active
Contact: Narendranath Epperla
Phone: 801-585-0255
PRIMARY OBJECTIVES:
I. To evaluate the efficacy of SOC CAR T-cell therapy in patients with R/R large B-cell lymphoma following bridging with lonca-R.
II. To evaluate toxicities post CAR-T.
SECONDARY OBJECTIVES:
I. To assess the safety and tolerability of lonca-R in the study population.
II. To determine whether CD19 expression is reduced in patients who receive bridging with lonca-R prior to CAR-T.
III. To evaluate the level of disease control provided by bridging lonca-R.
EXPLORATORY OBJECTIVES:
I. To describe the number of cycles of lonca-R administered compared to the efficacy of CAR-T.
II. Time to event analyses post CAR-T.
III. To evaluate post-CAR-T cytokine release syndrome (CRS) and immune-effector cell-associated neurotoxicity syndrome (ICANS).
OUTLINE:
Patients receive loncastuximab tesirine intravenously (IV) over 30 minutes followed by rituximab IV on day 1 of each cycle. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients undergo blood sample collection, computed tomography (CT) and positron emission tomography (PET) or PET/CT throughout the study. Patients may also undergo tissue biopsy or bone marrow aspiration throughout the study.
After completion of study treatment, patients who are unable to receive CAR T-cell therapy are followed up at 7 and 60 days, patients who receive CAR T-cell therapy are followed up at 7 and 30 days and prior to initiation of lymphodepletion chemotherapy and then every 3 months for up to 1 year after CAR-T administration.
Lead OrganizationHuntsman Cancer Institute/University of Utah
Principal InvestigatorNarendranath Epperla
