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

Asclepius Technology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Malignant Tumor

Treatments: Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03931720

AsclepiusTCG

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18~75 years old, male or female
2. Life expectancy ≥ 6 months
3. ECOG score: 0-3
4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
5. Advanced solid tumor was diagnosed by pathological or clinical physicians
6. 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
7. Signed informed consent
8. 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

1. Expected overall survival < 6 months
2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months
3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%
4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

Experimental group

Description:

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

Treatment:

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