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出境医 / 临床实验 / Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

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

Study Description
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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 9 participants
Allocation: N/A
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
Arms and Interventions
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.
Outcome Measures
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.


Eligibility Criteria
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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
Contacts and Locations

Contacts
Layout table for location contacts
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.
Tracking Information
First Submitted Date  ICMJE May 6, 2019
First Posted Date  ICMJE May 8, 2019
Last Update Posted Date May 8, 2019
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 6, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Official Title  ICMJE Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Pancreatic Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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).
Intervention: Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 6, 2019) 		9
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2022
Estimated Primary Completion Date May 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com
Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03941457
Other Study ID Numbers  ICMJE AsclepiusTCG03
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Asclepius Technology Company Group (Suzhou) Co., Ltd.
Study Sponsor  ICMJE Asclepius Technology Company Group (Suzhou) Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Asclepius Technology Company Group (Suzhou) Co., Ltd.
Verification Date May 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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