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


2019-05


2021-05


2022-05


9

Study Overview

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

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.

N/A

  • Pancreatic Cancer
  • BIOLOGICAL: BiCAR-NK cells (ROBO1 CAR-NK cells)
  • AsclepiusTCG03

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates Results Reporting Dates Study Record Updates

2019-05-06  

N/A  

2019-05-06  

2019-05-06  

N/A  

2019-05-08  

2019-05-08  

N/A  

2019-05  

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

Primary Purpose:
Treatment


Allocation:
Na


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)

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)

  • The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Primary Outcome MeasuresMeasure DescriptionTime Frame
Occurrence of treatment related adverse events as assessed by CTCAE v4.03Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Guangfu Li

Phone Number: +86 13615181959

Email: lgf@atcgcell.com

Study Contact Backup

Name: Xianfeng Feng

Phone Number: +86 15157190521

Email: fxf@atcgcell.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person’s general health condition or prior treatments.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

    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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available