Expanded Access Neoantigen Vaccine in Solid Tumors

The Washington University

Status

Conditions: Solid Tumor, Adult

Treatments: Device: Integrated electroporation device; Biological: Neoantigen DNA Vaccine

Study type: Expanded Access

Funder types: Other

Identifiers

NCT03914872

19-x005

Details and patient eligibility

About

This is an expanded access use study. Safety data will be collected from participants.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically or cytologically confirmed diagnosis of a solid tumor
• Pathology review demonstrates tumor cellularity of >30% in quantities sufficient to complete DNA and RNA library construction
• At least 18 years of age.
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control, abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she must inform her treating physician immediately.
• Able to understand and willing to sign an IRB approved written informed consent document.

Exclusion criteria

• Known allergy, or history of serious adverse reaction to vaccines such as anaphylaxis, hives, or respiratory difficulty.
• Acute or chronic, clinically significant hematologic, pulmonary, cardiovascular, hepatic renal, and/or other functional abnormality that would jeopardize the health and safety of the participant as determined by the investigator based on medical history, physical examination, laboratory values, and/or diagnostic studies.
• History of syncopal or vasovagal episode as determined by medical record and history in the 12 month period prior to first vaccination administration.
• Individuals in whom a skinfold measurement of the cutaneous and subcutaneous tissue for eligible injection sites (left and right medial deltoid region) exceeds 40 mm.
• Individuals in whom the ability to observe possible local reactions at the eligible injection sites (deltoid region) is, in the opinion of the investigator, unacceptably obscured due to a physical condition or permanent body art.
• Therapeutic or traumatic metal implant in the skin or muscle of either deltoid region.
• Any chronic or active neurologic disorder, including seizures and epilepsy, excluding a single febrile seizure as a child.
• Current use of any electronic stimulation device, such as cardiac demand pacemakers, automatic implantable cardiac defibrillator, nerve stimulators, or deep brain stimulators.
• Pregnant and/or breastfeeding.