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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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

  • Clinicaltrials.gov identifier

    NCT03931720

  • Recruitment Status

    Recruiting

  • 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

N/A

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

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 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

Contacts

Contact: Guangfu Li +86 13615181959 lgf@atcgcell.com

Contact: Xianfeng Feng +86 15157190521 fxf@atcgcell.com

Locations

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

Sponsors and Collaborators

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

More Information

  • Responsible Party: Asclepius Technology Company Group (Suzhou) Co., Ltd.
  • ClinicalTrials.gov 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
    Statement:

  • 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