Trial | NCT03931720  Report issue

Official Title

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

  • 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. 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.
Study Started
May 31
2019
Anticipated
Primary Completion
May 31
2021
Anticipated
Study Completion
May 31
2022
Anticipated
Last Update
Apr 30
2019

Biological BiCAR-NK/T cells (ROBO1 CAR-NK/T 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 BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) Experimental

Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).

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≥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
No Results Posted