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

Program Status

Recruiting

Phase

Phase 1/Phase 2

Prior Immunotherapy Allowed

No

CRC-directed Trial

No

Drugs

ROBO1 CAR-NK cells

Tags

MSI-H/ MMRd, MSS/ MMRp
Location Location Status
China
Radiation Therapy Department, Suzhou Cancer Center, Suzhou Hospital Affiliated to Nanjing Medical University
Suzhou, Jiangsu 215001
Recruiting

Contacts

Guangfu Li
Contact
+86 13615181959 lgf@atcgcell.com
Xianfeng Feng
Contact
+86 15157190521 fxf@atcgcell.com

Inclusion 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

Exclusion Criteria:

Expected overall survival 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

NCT ID

NCT03940820

Date Trial Added

2019-05-07

Updated Date

2019-05-07