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

  • identifier


  • Recruitment Status


  • First Posted

    April 30, 2019

  • Last update posted

    April 30, 2019

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 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:Malignant Tumor
  • Intervention/Treatment: Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)
  • Phase: Phase 1/Phase 2

Detailed Description


Study Design

  • Study Type: Interventional
  • Estimated Enrollment: 20 participants
  • 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

Arms and interventions

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.

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

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


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 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

Contacts and Locations


Contact: Guangfu Li +86 13615181959

Contact: Xianfeng Feng +86 15157190521


China, Jiangsu
Department of Oncology, Suzhou Kowloon Hospital, Shanghai Jiaotong University School of Medicine

Sponsors and Collaborators

Asclepius Technology Company Group (Suzhou) Co., Ltd.

More Information

  • Responsible Party: Asclepius Technology Company Group (Suzhou) Co., Ltd.
  • Identifier: NCT03931720 History of Changes
  • 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

  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Neoplasms