Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Study Overview
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Brief Summary
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Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. ROBO1 is a potential target and spectacular paradigm in the treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.

Official Title
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Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Conditions
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Pancreatic Cancer

Intervention / Treatment
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* Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically confirmed metastatic pancreatic adenocarcinoma Patients aged between 18 and 75 ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC) Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy greater than 3 months Subjects must have measurable disease as defined by RECIST 1.1 criteria 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 Karnofsky score ≥ 60 Ability to give informed consent Exclusion Criteria: Previously treated with any gene therapy products Patients who are receiving any other investigational agents Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease) Concurrent opportunistic infections

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)<br>Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells). | Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)<br>* The subject will be observed for any side effects during this time and all the adverse events will be recorded.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment related adverse events as assessed by CTCAE v4.03 | Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment. | 1 year |