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

Primary Purpose

Pancreatic Cancer

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
BiCAR-NK cells (ROBO1 CAR-NK cells)
Sponsored by
Asclepius Technology Company Group (Suzhou) Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pancreatic Cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Department of Radiology, Shanghai Ruijin HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
May 6, 2019
Last Updated
May 6, 2019
Sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03941457
Brief Title
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Official Title
Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Unknown status
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
May 2021 (Anticipated)
Study Completion Date
May 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asclepius Technology Company Group (Suzhou) Co., Ltd.

4. Oversight

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

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pancreatic Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)
Arm Type
Experimental
Arm Description
Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).
Intervention Type
Biological
Intervention Name(s)
BiCAR-NK cells (ROBO1 CAR-NK cells)
Intervention Description
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Primary Outcome Measure Information:
Title
Occurrence of treatment related adverse events as assessed by CTCAE v4.03
Description
Defined as >= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guangfu Li
Phone
+86 13615181959
Email
lgf@atcgcell.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xianfeng Feng
Phone
+86 15157190521
Email
fxf@atcgcell.com
Facility Information:
Facility Name
Department of Radiology, Shanghai Ruijin Hospital
City
Shanghai
ZIP/Postal Code
200025
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhongmin Wang, PhD
Email
james0722@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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