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

NCT03941457 | Unknown Phase 1

• 1 other identifier: AsclepiusTCG03
• Study Type: interventional
• Target: 9
• 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 treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.

Conditions

Pancreatic Cancer

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 cells (ROBO1 CAR-NK cells)

EXPERIMENTAL

Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).

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

Interventions

BiCAR-NK cells (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 BiCAR-NK cells (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:

• Histologically confirmed metastatic pancreatic adenocarcinoma
• Patients aged between 18 and 75
• ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy greater than 3 months
• Subjects must have measurable disease as defined by RECIST 1.1 criteria
• 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
• Karnofsky score ≥ 60
• Ability to give informed consent

You may not qualify if:

• Previously treated with any gene therapy products
• Patients who are receiving any other investigational agents
• Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
• Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
• Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
• Concurrent opportunistic infections

Sponsors & Collaborators

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

Study Sites (1)

Department of Radiology, Shanghai Ruijin Hospital

Shanghai, 200025, China

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases

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 6, 2019
• First Posted: May 8, 2019
• Study Start: May 1, 2019
• Primary Completion: May 1, 2021
• Study Completion: May 1, 2022
• Last Updated: May 8, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)