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

NCT03931720 | Unknown Phase 1

• 1 other identifier: AsclepiusTCG
• 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. 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.

Conditions

Malignant 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 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).

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

Interventions

BiCAR-NK/T cells (ROBO1 CAR-NK/T 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 BiCAR-NK/T cells (ROBO1 CAR-NK/T 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≥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

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)

Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine

Suzhou, Jiangsu, 215021, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

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: April 25, 2019
• First Posted: April 30, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: April 30, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)