This phase Ib trial studies the side effects and how well rapcabtagene autoleucel works in treating large B-cell lymphoma (LBCL) in patients who are at a high risk of the lymphoma coming back after front-line therapy (relapse). Sometimes after front-line therapy is complete, fragments of deoxyribonucleic acid (DNA) from cancer cells remain and are released into the bloodstream which is referred to as circulating tumor DNA (ctDNA). When the ctDNA is positive following front-line therapy, a patient is considered to be positive for measurable residual disease (MRD) which may place them at a high risk of relapse. Rapcabtagene autoleucel is a type of chimeric antigen receptor (CAR) T-cell therapy which is a type of treatment in which a patient's T cells (a type of immune system cell) are changed in the laboratory so they will attack cancer cells. T cells are taken from a patient’s blood. Then the gene for a special receptor that binds to a certain protein on the patient’s cancer cells is added to the T cells in the laboratory. The special receptor is called a CAR. Large numbers of the CAR T cells are grown in the laboratory and given to the patient by infusion for treatment of certain cancers. Before patients receive rapcabtagene autoleucel chemotherapy is given. Giving chemotherapy, such as cylophosphamide and fludarabine, before CAR T-cell therapy helps kill cancer cells in the body and helps rapcabtagene autoleucel work. Giving rapcabtagene autoleucel after front-line therapy may kill any remaining MRD, which may be an effective way to treat LBCL in patients who are at high risk of relapse following front-line therapy
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07443137.
Locations matching your search criteria
United States
California
Palo Alto
Stanford Cancer Institute Palo AltoStatus: Approved
Contact: Saurabh Dahiya
Phone: 650-452-8155
PRIMARY OBJECTIVES:
I. Assess the efficacy of rapcabtagene autoleucel (YTB323) in adults with large B cell lymphoma (LBCL) who are at high risk of relapse at end of front-line (1L) treatment (EOT) as defined by measurable residual disease detected by Foresight CLARITY IUO.
II. Evaluate the safety of rapcabtagene autoleucel (YTB323) in adults when used as part of front-line risk adapted therapy.
SECONDARY OBJECTIVE:
I. Evaluate the clinical benefit of rapcabtagene autoleucel (YTB323) in adults with LBCL when used as part of first-line risk adapted therapy.
OUTLINE:
PRE-SCREENING: Patients undergo blood sample collection and tumor biopsy or archival tissue sample collection with MRD testing and positron emission tomography (PET)/computed tomography (CT) after 1L EOT. Patients with PET/CT demonstrating partial response (PR) or complete response (CR) who are MRD negative are assigned to the observational cohort. Patients with PET/CT demonstrating PR or CR (unable to be biopsied or biopsy negative) who are MRD positive are assigned to the treatment cohort. Patients with PET/CT demonstrating stable disease (SD), progressive disease (PD) or partial response (PR) (with biopsy proven disease) are taken off study and referred for standard of care.
OBSERVATIONAL COHORT: Patients undergo observation via phone calls or electronic medical record (EMR) review for documentation of additional therapies, response to therapy, disease status, and survival on study.
TREATMENT COHORT: Patients undergo leukapheresis for rapcabtagene autoleucel manufacturing at baseline. Patients then receive cyclophosphamide intravenously (IV) over 60 minutes and fludarabine IV over 30 minutes on days -5 to -3 and rapcabtagene autoleucel IV on day 0 in the absence of disease progression or unacceptable toxicity. Additionally, patients undergo blood sample collection and PET/CT throughout the study. Patients also undergo echocardiography (ECHO) and magnetic resonance imaging (MRI) during screening.
After completion of study treatment, treatment cohort patients are followed up at days 1-7, 14, and 28, months 3, 6, 9, 12, 18, and 24, and then annually for years 2-15.
Lead OrganizationStanford Cancer Institute Palo Alto
Principal InvestigatorSaurabh Dahiya
