Clinical trial of autologous tumor-specific T cells
- Conditions
- Neoplasms
- Registration Number
- KCT0004064
- Lead Sponsor
- CC Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 24
1) Subjects must be 20 ~ 75 years old
2) Patients with standard therapy-failed reccurrent sold cancers
3) Patients with hTERT-specific CD8 T cells in prior epitope screening.
4) Performance Status Score (ECOG/Zubrod Scale) must be =< 2
1) Patients who have Symptoms- or unregulated with metastasis in CNS
2) Patients recieved all immunosuppressive treatments such as chemotherapy or radiotherapy a minimum of 3 weeks prior to initiation of study
3) Leukocyte number < 2,500/ul, absolute numbers of neutrophils < 1,000/ul, platelet numbers < 50,000/ul, hemoglobin <9g/dL, serum creatinine > 2.0mg/dL, AST/ALT > 3x upper limit of normal range (ULN), total bilirubin > 2.0 mg/dL, Prothrombin time > 1.5 x ULN
4) Active cardiovascular diseases, including:
unregulated hypertension( Systolic blood pressure>180mmHg, Diastolic blood pressure>100mmHg), Unstable angina, Pulmonary embolisim, cerebrovascular disease, valvular disease of the heart , congestive heart failure or myocardial infarction in the last 6 months, or severe arrhythmia
5) Anti-HIV Ab positive
6) Patients with active autoimmune diseases or inflammatory diseases
7) Uncontrolled active infection/neurologic diseases
8) Patients with a previous history of immune cell therapy
9) Pregnant or breast-feeding women
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine maximum tolerated dose of autologous hTERT-specific CD8 T cells in patients with standard therapy-failed recurrent solid cancers
- Secondary Outcome Measures
Name Time Method Dose-limiting toxicity;safety;adverse effects;effectiveness