J1807 - A Phase 1 Clinical Trial To Evaluate The Safety And Immunogenicity Of A Neoantigen DNA Vaccine Strategy In Pancreatic Cancer Patients Following Surgical Resection And Adjuvant Chemotherapy
Johns Hopkins Kimmel Cancer Center in Baltimore
The purpose of this research study is to learn more about the safety and feasibility of injecting a personalized DNA vaccine into people with pancreatic cancer. DNA is material that contains the information needed to produce many substances in the body. The personalized DNA vaccine is designed to target mutations specific to each person’s tumor that are discovered during genetic testing of the tumor before study procedures start. Injection of this DNA vaccine may be a way to generate an immune response to tumor cells. An immune response is the way the body fights viruses and other infections. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the DNA injection, this study is also looking at the immune response that the body has after each injection.
Adults over 18 y.o. with life expectancy greater than 12 months with confirmed diagnosis of pancreatic adenocarcinoma; have completed an R0 or R1 surgical resection; pathology review should demonstrate tumor cellularity no less than 30% in quantities sufficient to obtain 6-8 1mm biopsies from the original FFPE blocks. Exclusions: neoadjuvant chemo; disease recurrence of metastasis at any time before vaccine administration; history of syncopal or vasovagal episode within last 12 months; skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm; any chronic or active neurologic disorder, including seizures and epilepsy; current use of any electronic stimulation device; prior or currently active autoimmune disease requiring management with immunosuppression; known HIV positive status.
Eligible patients will have their personalized DNA vaccine developed in accredited laboratory while receiving standard of care post-operative (adjuvant) chemotherapy for 4 to 6 months. After completion of adjuvant chemotherapy and confirmation of no disease recurrence by repeated imaging, patients will receive a personalized neoantigen DNA vaccine for total of 6 times (over 6 months) into the muscle (both arms or tights) via an electroporation device.
03/05/2019 05:03 AM