Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor

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 diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.

Official Title
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Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor

Conditions
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Malignant Tumor

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 75 years old, male or female Life expectancy ≥ 6 months ECOG score: 0-3 ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC) Advanced solid tumor was diagnosed by pathological or clinical physicians Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥70 x 10*9/L, hemoglobin≥80g/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 Signed informed consent 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: Expected overall survival < 6 months Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90% Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. Unable or unwilling to provide informed consent, or fail to comply with the test requirements

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/T cells (ROBO1 CAR-NK/T cells)<br>Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells). | Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T 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 |