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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03941457
Recruitment Status : Recruiting
First Posted : May 8, 2019
Last Update Posted : May 8, 2019
Sponsor:
Information provided by (Responsible Party):
Asclepius Technology Company Group (Suzhou) Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
Pancreatic Cancer Biological: BiCAR-NK cells (ROBO1 CAR-NK cells) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Resource links provided by the National Library of Medicine


Arm Intervention/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 Measures :
  1. Occurrence of treatment related adverse events as assessed by CTCAE v4.03 [ Time Frame: 1 year ]
    Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03941457


Contacts
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Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com
Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com

Locations
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China
Department of Radiology, Shanghai Ruijin Hospital Recruiting
Shanghai, China, 200025
Contact: Zhongmin Wang, PhD       james0722@163.com   
Sponsors and Collaborators
Asclepius Technology Company Group (Suzhou) Co., Ltd.

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Responsible Party: Asclepius Technology Company Group (Suzhou) Co., Ltd.
ClinicalTrials.gov Identifier: NCT03941457     History of Changes
Other Study ID Numbers: AsclepiusTCG03
First Posted: May 8, 2019    Key Record Dates
Last Update Posted: May 8, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases