Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Pancreatic Cancer Clinical Trial

Official title:

Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03941457
• Other study ID #: AsclepiusTCG03
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: May 2019
• Est. completion date: May 2022

Study information

• Verified date: May 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 treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9
• 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. Histologically confirmed metastatic pancreatic adenocarcinoma

2. Patients aged between 18 and 75

3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)

4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1

5. Life expectancy greater than 3 months

6. Subjects must have measurable disease as defined by RECIST 1.1 criteria

7. Satisfactory organ and bone marrow function: White blood cell count (WBC) = 3.0×10^9/L, Platelets = 70×10^9/L, Hb = 9.0g/dL, lymphocyte (LY) = 0.7×10^9/L, LY% = 15%, Alb = 2.8g/dL, serum lipase and amylase < 1.5 × upper limit of normal, serum creatinine = 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 5×upper limit of normal, serum total bilirubin = 2.0mg/dL. These tests must be conducted within 7 days prior to registration

8. Karnofsky score = 60

9. Ability to give informed consent

Exclusion Criteria:

1. Previously treated with any gene therapy products

2. Patients who are receiving any other investigational agents

3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant

4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses

5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)

6. Concurrent opportunistic infections

Related Conditions & MeSH terms

• Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Biological:
• BiCAR-NK cells (ROBO1 CAR-NK 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 Radiology, Shanghai Ruijin Hospital	Shanghai

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