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

NCT ID: NCT03931720

Last Updated: 2019-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2022-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Malignant Tumor

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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).

Group Type EXPERIMENTAL

BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

Intervention Type BIOLOGICAL

The subject will be observed for any side effects during this time and all the adverse events will be recorded.

Interventions

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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.

Intervention Type BIOLOGICAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Suzhou, Jiangsu, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guangfu Li

Role: CONTACT

Phone: +86 13615181959

Email: [email protected]

Xianfeng Feng

Role: CONTACT

Phone: +86 15157190521

Email: [email protected]

Facility Contacts

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Fengchun Zhang, PhD

Role: primary

Other Identifiers

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AsclepiusTCG

Identifier Type: -

Identifier Source: org_study_id