Official Title

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

    Phase 1/Phase 2
  • Study Type

  • Status

    Unknown status
  • Study Participants

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
Primary Completion
May 31
Study Completion
May 31
Last Update
May 07

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.


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