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

Phase 1

• Conditions: Malignant Tumor
• Interventions: Biological: BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)

• Registration Number: NCT03931720
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-04
• Study First Submitted: 2019-04-25
• Study First Submitted QC: 2019-04-27
• Last Update Submitted: 2019-04-27
• Study First Posted: 2019-04-30
• Last Update Posted: 2019-04-30
• Study Start: 2019-05
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-tumor response of BiCAR-NK/T cells (ROBO1 CAR-NK/T cells)	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).

Primary Outcome Measures

Name	Time	Method
Occurrence of treatment related adverse events as assessed by CTCAE v4.03	1 year	Defined as \>= Grade 3 signs/symptoms, laboratory toxicities, and clinical events) that are possibly, likely, or definitely related to study treatment.

Trial Locations

Locations (1)

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