Trial | NCT03940820  Report issue

Official Title

Clinical Research of ROBO1 Specific CAR-NK Cells on Patients With Solid Tumors

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    20
Immunotherapy has become the major breakthrough and the most promising treatment, with the host of development of tumor biology, molecular biology and immunology. We have developed anti-ROBO1 CAR-NK cells that can target tumor cells highly expressing ROBO1. The purpose of this study is to evaluate the safety and effectiveness of cell therapy using ROBO1 CAR-NK cells to treat solid tumors.
Study Started
May 31
2019
Anticipated
Primary Completion
May 31
2021
Anticipated
Study Completion
May 31
2022
Anticipated
Last Update
May 07
2019

Biological ROBO1 CAR-NK cells

The subject will be observed for any side effects during this time and all the adverse events will be recorded.

anti-tumor response of ROBO1 CAR-NK cells Experimental

Patients will receive a single dose of ROBO1 CAR-NK cells without any conditioning chemotherapeutic regimen.

Criteria 

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 ≥ 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
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
No Results Posted