Safety and Efficacy of Tag-7 Gene-modified Vaccine in Locally Advanced or Metastatic Malignant Melanoma or Kidney Cancer

This is an interventional treatment trial for Melanoma focused on measuring gene modified vaccine, tag-7, immunotherapy, tumor cells-based vaccine Read More

Inclusion Criteria:

1. Signed inform consent form.
2. Patients age ≥ 18 years of age at the time of informed consent.
3. Ability to provide and understand written informed consent prior to any study procedures.
4. Histologically confirmed locally advanced or metastatic MM or RCC.
5. Tumor cell culture should be obtained and successfully transfected before inclusion.
6. No evaluable therapy with a proved survival advantage in the current patient setting.
7. The life expectancy of > 3 months as estimated by the investigator
8. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 -2 at Screening.

Exclusion Criteria:

1. Patient with any out-of-range laboratory values defined as:

   • Serum creatinine > 1.5 × upper limit of normal (ULN) and/or creatinine clearance (calculated using Cockcroft-Gault formula, or measured) < 50 mL/minute
   • Total bilirubin > 2.5 × ULN, except for patients with Gilbert's syndrome who are excluded if total bilirubin > 3.0 × ULN or direct bilirubin > 1.5 × ULN
   • Alanine aminotransferase > 2.5 × ULN
   • Aspartate aminotransferase > 2.5 × ULN
   • Absolute neutrophil count < 1.5 × 109/L
   • Platelet count < 100 × 109/L
   • Hemoglobin < 80 g/L (blood transfusions permitted)
2. History of severe hypersensitivity reactions (eg, anaphylaxis) to other biologic drugs or monoclonal antibodies
3. Any clinically significant unstable disease
4. Presence of symptomatic or untreated central nervous system (CNS) metastases
5. Active infection requiring systemic antibiotic therapy. Patients requiring systemic antibiotics for infection must have completed therapy at least 1 week prior to the first dose of study drug
6. Known history of human immunodeficiency virus infection (HIV). Testing for HIV status is not necessary unless clinically indicated
7. Active hepatitis B virus (HBV) or hepatitis C virus (HCV) infection per institutional protocol. Testing for HBV or HCV status is not necessary unless clinically indicated or the patient has a history of HBV or HCV infection
8. Malignant disease, other than that being treated in this study
9. Patients receiving systemic steroid therapy or any other systemic immunosuppressive medication at any dose level, as these may interfere with the mechanism of action of study treatment. Local steroid therapies (eg, otic, ophthalmic, intra-articular or inhaled medications) are acceptable
10. Pregnant, likely to become pregnant, or lactating women (where pregnancy is defined as the state of a female after conception and until the termination of gestation)