Evaluationn of Tolerability and Safety of CBT101, an Autologous Natural Killer Cell, in Patients With Solid Cancer
NCT ID: NCT04557306
Last Updated: 2024-04-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
6 participants
INTERVENTIONAL
2020-09-21
2021-10-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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CBT101 q2w
CBT101 cells, every 2 weeks
CBT101 cells, every 2 weeks
CBT101 cells, every 4 weeks
CBT101 q4w
CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks
Interventions
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CBT101 cells, every 2 weeks
CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks
CBT101 cells, every 4 weeks
Eligibility Criteria
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Inclusion Criteria
2. Patients with solid tumors as below (1) histologically or cytologically confirmed solid tumors (2) 4 - 12 weeks of last adjuvant therapy after radical operations and adjuvant therapy
3. Life expectancy 6 months
4. Eastern Cooperative Oncology Group perfornace status (ECOG PS) 0-1
Exclusion Criteria
2. History of peritoneal carninomatosis
3. Hemoglobine less than 9.0g/dL
4. Absolute Neutrophil Count (ANC) less than 1.5x10\^3/mm\^3
5. Platelet count less than 75x10\^9/L
6. Total bilitbinn grater than 1.5 times te upper limit of normal
7. Alanine amino transferase (ALT) greater than 3 times the upper limit of normal
8. Alanine phospatase (ALP) greater than 2.5 times the upper limit of normal
9. Uncontrolled hypertension
10. Intensive insuline therapy
11. Active infectious disease
12. Patients with hypersensitivity history or allergy to investigational product
13. Pregmant of lactating woman
14. Patients who have participated in another clinical trials witin 30 days before the start of this clinical trial
15. Patients judged to be inappropriate for this study by the investigator with other reasons
19 Years
ALL
No
Sponsors
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CHABiotech CO., Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Chan Kim
Role: PRINCIPAL_INVESTIGATOR
CHA Bundang Medical Center
Locations
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CHA Bundang Medical Center
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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CBT101_P1
Identifier Type: -
Identifier Source: org_study_id
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