Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
NCT ID: NCT03941457
Last Updated: 2019-05-08
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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UNKNOWN
PHASE1/PHASE2
9 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 BiCAR-NK cells (ROBO1 CAR-NK cells)
Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).
BiCAR-NK cells (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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BiCAR-NK cells (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. Patients aged between 18 and 75
3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than 3 months
6. Subjects must have measurable disease as defined by RECIST 1.1 criteria
7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10\^9/L, Platelets ≥ 70×10\^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10\^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase \< 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration
8. Karnofsky score ≥ 60
9. Ability to give informed consent
Exclusion Criteria
2. Patients who are receiving any other investigational agents
3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
6. Concurrent opportunistic infections
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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Department of Radiology, Shanghai Ruijin Hospital
Shanghai, , China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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AsclepiusTCG03
Identifier Type: -
Identifier Source: org_study_id
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