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

Malignant Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03931720
• Other study ID #: AsclepiusTCG
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2019
• Est. completion date: May 2022

Study information

• Verified date: April 2019
• Source: Asclepius Technology Company Group (Suzhou) Co., Ltd.
• Contact: Guangfu Li
• Phone: +86 13615181959
• Email: lgf[@]atcgcell.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: May 2022
• Est. primary completion date: May 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Malignant Tumor
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine	Suzhou	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Asclepius Technology Company Group (Suzhou) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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