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Clinical Research of ROBO1 Specific BiCAR-NK/T Cells on Patients With Malignant Tumor

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: NCT03931720
Recruitment Status : Recruiting
First Posted : April 30, 2019
Last Update Posted : April 30, 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 diagnosis and treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK/T cell immunotherapy for malignant tumors.

Condition or disease Intervention/treatment Phase
Malignant Tumor Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells) Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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/T Cells on Patients With Malignant Tumor
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2022

Arm Intervention/treatment
Experimental: anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
Patients with relapsed and refractory cancer of ROBO1 expression will be treated with BiCAR-NK/T cells (ROBO1 CAR-NK/T cells).
Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T 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. Age 18~75 years old, male or female
  2. Life expectancy ≥ 6 months
  3. ECOG score: 0-3
  4. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
  5. Advanced solid tumor was diagnosed by pathological or clinical physicians
  6. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥70 x 10*9/L, hemoglobin≥80g/L, lymphocyte count≥15%, total bilirubin≤100 mol/L, ALT and AST less than five times of the normal level, serum creatinine less than 1.5 times of the normal level
  7. Signed informed consent
  8. Women of child-bearing age must have evidence of negative pregnancy test and be willing to practice birth control after 2 weeks following the cell transfusion

Exclusion Criteria:

  1. Expected overall survival < 6 months
  2. Patients with uncontrolled hypertension, unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months
  3. Abnormal lung function: FEV (forced expiratory volume) < 30% prediction, DLCO (diffusing capacity of the lung for carbon monoxide) < 30% prediction, blood oxygen saturation < 90%
  4. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc.
  5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements

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): NCT03931720


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, Jiangsu
Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine Recruiting
Suzhou, Jiangsu, China, 215021
Contact: Fengchun Zhang, PhD       fczhang2004@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: NCT03931720    
Other Study ID Numbers: AsclepiusTCG
First Posted: April 30, 2019    Key Record Dates
Last Update Posted: April 30, 2019
Last Verified: April 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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Neoplasms