Clinical Research Directory

Real-world Clinical Effectiveness & Safety LV009, an in Vivo CAR-T for the Treatment of Hematologic Cancers, Auto-immune Diseases & HLA/ AAV Sensitization.

The study objective is to determine the real-world safety and effectiveness of LV009 therapy for 3 potential indications: (1) refractory or relapsed hematologic cancers (acute lymphoblastic Leukemia, B cell Lymphomas, multiple myeloma), (2) auto-immune diseases, (3) de-sensitization of patients awaiting organ transplant or AAV-based gene therapy who have pre-existing anti-HLA or anti-AAV antibodies. This is an observational study designed to determine the real-world safety and effectiveness of LV009, an in vivo CAR-T therapy, among patients with hematologic cancers, auto-immune diseases, or HLA/AAV sensitization. Following the administration of LV009, patient will be monitored for toxicity and response to treatment. No subjects will be withdrawn from the study, and subjects could freely drop out from the study anytime, simply by not showing up. The study objective is to determine the real-world safety and effectiveness of LV009 therapy for 3 potential indications: (1) refractory or relapsed hematologic cancers (acute lymphoblastic Leukemia, B cell Lymphomas, multiple myeloma), (2) auto-immune diseases, (3) de-sensitization of patients awaiting organ transplant or AAV-based gene therapy who have pre-existing anti-HLA or anti-AAV antibodies.

Genomic Profiling in Cancer Patients

The purpose of this study is to determine whether certain genes in cancer may be abnormal. When a gene is abnormal this is called a mutation. Most mutations in cancer cells are not inherited (passed down from parents) but happen after birth in the cancer itself. Most cancers have many mutations. Some of these mutations are important for the cancer cells to survive while others are not. The goal of this study is test cancer for certain mutations using leftover tumor tissue from a previous surgery or biopsy. Participants will also be asked to provide a tube of blood cheek (also known as a buccal) swab, or a saliva sample that contains normal genes for comparison. The purpose of Part B of this study is to: Understand how genetic changes in tumor effect the chance of responding to experimental cancer treatment. Understand how the genes in the tumor change overtime in response to targeted cancer treatment.

Phase 2 Study Assessing Secured Access to Vemurafenib for Patients With Tumors Harboring BRAF Genomic Alterations

Patients with metastatic or unresectable locally advanced malignancies harboring BRAF genomic alterations, the biological target of vemurafenib, and who are no more amenable to curative treatment. To explore the efficacy of vemurafenib as a single agent across diverse type of tumors guided by the presence of identified activating molecular alterations in the vemurafenib target gene, per cohort.