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

NCT03940820 | Unknown Phase 1

• 1 other identifier: AsclepiusTCG01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• Occurrence of treatment related adverse events as assessed by CTCAE v4.03

  Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

  1 year

Study Arms (1)

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.

Biological: ROBO1 CAR-NK cells

Interventions

ROBO1 CAR-NK cells BIOLOGICAL

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

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Asclepius Technology Company Group (Suzhou) Co., Ltd.: lead

Study Sites (1)

Radiation Therapy Department, Suzhou Cancer Center, Suzhou Hospital Affiliated to Nanjing Medical University

Suzhou, Jiangsu, 215001, China

RECRUITING

Central Study Contacts

Guangfu Li

CONTACT

+86 13615181959; lgf@atcgcell.com

Xianfeng Feng

CONTACT

+86 15157190521; fxf@atcgcell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 5, 2019
• First Posted: May 7, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: May 7, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)