KITE-439 / Gilead, Fosun Pharma, National Institutes of Health - LARVOL DELTA

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Mar 2041 ➔ Dec 2040 | Trial primary completion date: Mar 2041 ➔ Dec 2040

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov) - P2 | N=700 | Enrolling by invitation | Sponsor: Kite, A Gilead Company | Trial completion date: Nov 2026 ➔ Mar 2041 | Trial primary completion date: Nov 2026 ➔ Mar 2041

Trial completion date • Trial primary completion date • Hematological Disorders • Hematological Malignancies • Oncology

Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (clinicaltrials.gov) - P1 | N=7 | Terminated | Sponsor: Kite, A Gilead Company | Active, not recruiting ➔ Terminated; Development program terminated

Trial termination • Oncology • HLA-A

Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (clinicaltrials.gov) - P1; N=7; Active, not recruiting; Sponsor: Kite, A Gilead Company; Trial completion date: Dec 2021 ➔ Mar 2022

Clinical • Trial completion date • Oncology • HLA-A

Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (clinicaltrials.gov) - P1; N=7; Active, not recruiting; Sponsor: Kite, A Gilead Company; Recruiting ➔ Active, not recruiting; N=51 ➔ 7; Trial completion date: Aug 2037 ➔ Dec 2021; Trial primary completion date: Aug 2022 ➔ Dec 2021

Clinical • Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Oncology • HLA-A

[VIRTUAL] KITE-439: A phase I study of HPV16 E7 T cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers. (ASCO 2020) - P1 | "Patients in Phase 1A and Phase 1B may receive optional bridging therapy followed by cyclophosphamide and fludarabine conditioning chemotherapy. Key exclusion criteria include a history of stroke, myocardial infarction, or symptomatic deep vein thrombosis/pulmonary embolism, known infection with human immunodeficiency virus, detectable hepatitis C, or detectable hepatitis B. This study is currently open and accruing patients. Research Funding: Kite, a Gilead Company"

Clinical • P1 data • Acute Coronary Syndrome • Cardiovascular • Cervical Cancer • Gene Therapies • Gynecologic Cancers • Head and Neck Cancer • Hematological Disorders • Hepatitis B • Hepatitis C • Human Immunodeficiency Virus • Immunology • Infectious Disease • Myocardial Infarction • Oncology • Pulmonary Embolism • Squamous Cell Carcinoma of Head and Neck • Venous Thromboembolism

Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (clinicaltrials.gov) - P1; N=71; Recruiting; Sponsor: Kite, A Gilead Company; Trial completion date: May 2037 ➔ Aug 2037; Trial primary completion date: May 2022 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Oncology

Safety and Efficacy of KITE-439 in HLA-A*02:01+ Adults With Relapsed/Refractory HPV16+ Cancers (clinicaltrials.gov) - P1; N=75; Recruiting; Sponsor: Kite, A Gilead Company; Trial completion date: Oct 2036 ➔ Feb 2037

Clinical • Trial completion date • Oncology

Gilead and Kite continue to advance next generation cancer therapies at 2020 American Society of Clinical Oncology Annual Meeting (Gilead Press Release) - "Gilead Sciences...and Kite, a Gilead Company, today announced the acceptance of nine abstracts, including three oral presentations across its immuno-oncology research and development program, during the 2020 American Society of Clinical Oncology (ASCO) Annual Meeting being held from May 29-31, 2020. Data at ASCO include abstracts highlighting Kite’s leading cell therapy portfolio and magrolimab, an investigational anti-CD47 monoclonal antibody developed by Forty Seven, Inc., which was recently acquired by Gilead."

Clinical data • P1 data • P2 data • Acute Myelogenous Leukemia • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Lymphoma • Mantle Cell Lymphoma • Myelodysplastic Syndrome • Non-Hodgkin’s Lymphoma • Oncology • Solid Tumor

City of Hope now enrolling patients for first-in-human T cell trial for HPV-associated cancers (Businesswire) - "The first-in-human, phase 1 T cell trial for patients who have human papillomavirus (HPV)-associated cancers that have relapsed, or are resistant to treatment, is now open at City of Hope. The institution is the first to open such a trial on the West Coast...For the trial, a person’s own T cells will be collected and genetically engineered in a laboratory with KITE-439, an E7 T-cell receptor....Patients will receive a single dose of KITE-439."

Enrollment open