None listed
Conditions
Interventions
Biological/Vaccine, Non-Stem Cell : 1. Drug name: WT1-specific autologous CD8 T cells
2. Doses
- Stage 1: 1.0 x10e8/m2 (Day 0)
- Stage 2: 50mg/m2 Temozolomide (Day -14~-1)+1.0 x10e8/m2 (Day 0)
- St
Sponsors
National Cancer Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Men and women between the ages of 18 and 75 2) In the case of a histologically or cytologically confirmed advanced solid cancer patients who fails to respond to standard treatment or cannot be treated 3) WT1 antigen epitope screening test must be passed 4) Performance Status Score Karnofsky performance status must be = 50 or ECOG Scale must be =< 2 5) Expected survival period of at least 12 weeks 6) Patients who have listened to the explanation before the trial and voluntarily consented in writing by the patient or his/her representative
Exclusion criteria
Exclusion criteria: 1) Performance Status Score (Karnofsky performance status 2 2) History of surgery, radiation therapy, or chemotherapy within 3 weeks of trial registration 3) The following test results - Absolute neutrophil count 2.0 mg/dL - AST/ALT >3 x upper limit of normal range (ULN) - Total bilirubin >2.0 mg/dL - prothrombin time >1.5 x ULN 4) If there was an increase in the steroid dose at least 2 weeks before registration 5) Clinically significant active cardiovascular disease, including: Uncontrolled hypertension (i.e., systolic blood pressure >180 mmHg, diastolic blood pressure >100 mmHg), unstable angina, pulmonary embolism, cerebrovascular disease, valvular disease, congestive heart failure, or myocardial infarction within the past 6 months, or serious cardiac arrhythmias 6) Anti-HIV antibody positive patient 7) Patients with confirmed tuberculosis infection within 1 year. However, patients who have been cured for 6 months after treatment are included in the clinical trial. 8) Patients with autoimmune disease or inflammatory disease 9) If you are taking immunosuppressants other than steroids, you must stop 3 weeks before registration. 10) active infection 11) Patients with serious medical conditions that may interfere with other clinical trials 12) Patients who have received other investigational drugs within 3 weeks of trial registration 13) Patients who have previously received cultured immune cells 14) Pregnant, or breastfeeding 15) Women or men of childbearing age who do not want to use effective contraceptive methods 16) Patients with dementia or significant psychiatric or social problems that may limit their understanding or interfere with the performance of the requirements of the subject consent form and clinical trial protocol
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Dose-limiting toxicity;Safety;Adverse effects;Effectiveness | — |
Primary
| Measure | Time frame |
|---|---|
| To determine maximum tolerated dose of autologous WT1-specific CD8 T cells in patients with standard therapy-failed recurrent solid cancers | — |
Countries
Korea, Republic of
Contacts
Public ContactYOUNGJOO LEE
National Cancer Center
Outcome results
None listed