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

Phase 1

• Conditions: Solid Tumor
• Interventions: Biological: ROBO1 CAR-NK cells

• Registration Number: NCT03940820
• Lead Sponsor: Asclepius Technology Company Group (Suzhou) Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05
• Study First Submitted: 2019-05-05
• Study First Submitted QC: 2019-05-05
• Last Update Submitted: 2019-05-05
• Study First Posted: 2019-05-07
• Last Update Posted: 2019-05-07
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 ≥ 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
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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-tumor response of ROBO1 CAR-NK cells	ROBO1 CAR-NK cells	Patients will receive a single dose of ROBO1 CAR-NK cells without any conditioning chemotherapeutic regimen.

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment related adverse events as assessed by CTCAE v4.03	1 year	Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

Trial Locations

Locations (1)

Radiation Therapy Department, Suzhou Cancer Center, Suzhou Hospital Affiliated to Nanjing Medical University; 🇨🇳 Suzhou, Jiangsu, China