Advanced Malignant Melanoma
Conditions
Interventions
Sponsors
Anhui Province Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Stage III/B or IV malignant melanoma; 2. Measurable disease; 3. Progressed after all standard treatment; 4. ECOG performance status of 0-2; 5. Expected life span: >= 3 months; 6. Toxicities from prior treatment has resolved. Washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy; 7. Major organs function normally; 8. Women at pregnant ages should be under contraception; 9. Hematologic studies satisfy the following requirements within 1 week before treatment WBC=3×10^9/L; ANC=1.5×10^9/L; Hb=80g/L;
Exclusion criteria
Exclusion criteria: 1. Pathology is not malignant melanoma; 2. Emergent treatment of tumor emergency is needed; 3. Poor vasculature; 4. Coagulopathy, or ongoing thrombolytics and/or anticoagulation; 5. Blood-borne infectious disease, e.g. hepatitis B; 6. History of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician; 7. With other immune diseases, or chronic use of immunosuppressants or steroids; 8. Compliance cannot be expected; 9. Other conditions requiring exclusion deemed by physician.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Response Rate;Progression free survival (PFS);Overall Survival (OS);Peripheral blood circulating tumor DNA;Temporal Interleukin-2 change in the peripheral blood;Temporal Interferon-? change in the peripheral blood; | — |
Primary
| Measure | Time frame |
|---|---|
| Number of participants with Adverse Events and/or Dose Limiting Toxicities as a Measure of Safety and tolerability of dose of PD-1 Knockout T cells using Common Terminology Criteria for Adverse Events (CTCAE v4.0) in patients; | — |
Countries
China
Contacts
Public ContactYueyin Pan
Anhui Province Hospital
Outcome results
None listed