Investigator Clinical Phase 1/2 Study of Immunotherapy Using Autologous Killer Cell in Patients with Recurrent Glioblastoma

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0003815
• Lead Sponsor: Bundang CHA General Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 23 April 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Individuals aged 20 years to 69 years
2. Individuals for whom the standard therapy failed after being diagnosed with recurrent glioblastoma based on an MRI scan
3. Individuals whose survival period is at least 3 months
4. Individuals with an appropriate bone marrow function
- Hemoglobin count = 10 g/dL
- Leukocyte count = 3,000/mm3
- Absolute neutrophil count = 1,500/ML
- Platelet count = 75.000/mm3
5. Individuals with appropriate liver and kidney functions
- Total bilirubin = 1.5 times the normal upper limit specified by the testing agency
- AST, ALT = 2.5 times the normal upper limit specified by the testing agency
- Alkaline phosphatase = 1.5 times the normal upper limit specified by the testing agency
- Normal kidney function (serum creatinine = normal upper limit specified by the testing agency)
6. Individuals who have obtained a sufficient explanation of the purpose and details of the clinical trial and the characteristics of the investigational drug from an investigator and who signed the consent form or had a legal guardian or representative sign the consent form prior to the beginning of the clinical trial
7. In the case of women, they must have been tested negative in a urine or blood test for pregnancy seven days before the beginning of the clinical trial and agreed to use an appropriate method of contraception during the clinical trial
8. Individuals who have not had any blood infection within the last 6 months
9. Individuals who have not received any other forms of immunotherapy

Exclusion Criteria

1. An individual who is deemed to have a severe cardiopulmonary dysfunction by an investigator
2. An individual with immune deficiency or an autoimmune disease that may be exacerbated by immunotherapy (e.g. rheumatoid arthritis, systemic lupus erythematosus, vasculitis, multiple sclerosis, juvenile-onset insulin-dependent diabetes mellitus, etc.)
3. A carrier of chronic hepatitis B and/or C or who is HIV antibody positive
4. An individual with history of severe allergic reactions
5. An individual with uncontrolled hypertension or diabetes
6. A pregnant or lactating woman
7. An individual who is considered to be unfit for the clinical trial due to a serious medical or psychiatric condition
8. An individual with a major hemorrhagic disease not associated with cancer
9. An individual who has participated in another clinical trial within 4 weeks before the start of this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Adverse event;Clinical laboratory tests;Vital signs and physical examination;Progression-free survival;Overall survival;Treatment response rate according to the tumor evaluation

Secondary Outcome Measures

Name	Time	Method
QLQ-C30 (ver 3.0) Korean;Karnofsky performance status (KPS);Evaluation of immune reaction