Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors
NCT ID: NCT03940820
Last Updated: 2019-05-07
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2019-05-31
2022-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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anti-tumor response of ROBO1 CAR-NK cells
Patients will receive a single dose of ROBO1 CAR-NK cells without any conditioning chemotherapeutic regimen.
ROBO1 CAR-NK cells
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Interventions
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ROBO1 CAR-NK cells
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Eligibility Criteria
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Inclusion Criteria
2. Life expectancy ≥ 6 months
3. ECOG score: 0 - 3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. Laboratory examination: white blood cell ≥ 3 x 10\*9/L, blood platelet count ≥ 60 x 10\*/L, hemoglobin ≥ 85g/L; lymphocyte count ≥ 15%, total bilirubin ≤ 100 mol/L; ALT and AST less than five times of the normal level; serum creatinine less than 1.5 times of the normal level
7. Signed informed consent
8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion
Exclusion Criteria
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (\> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) \< 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) \< 30% prediction, blood oxygen saturation \< 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements
18 Years
75 Years
ALL
No
Sponsors
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Asclepius Technology Company Group (Suzhou) Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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Radiation Therapy Department, Suzhou Cancer Center, Suzhou Hospital Affiliated to Nanjing Medical University
Suzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AsclepiusTCG01
Identifier Type: -
Identifier Source: org_study_id
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