Clinical Research of ROBO1 Specific BiCAR-NK Cells on Patients With Pancreatic Cancer

Phase 1

• Conditions: Pancreatic Cancer
• Interventions: Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)

• Registration Number: NCT03941457
• 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 treatment of solid tumors. This study is for evaluation of the safety and efficacy of ROBO1 CAR-NK cell immunotherapy for pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Status Verified: 2019-05
• Study Start: 2019-05
• Study First Submitted: 2019-05-06
• Study First Submitted QC: 2019-05-06
• Last Update Submitted: 2019-05-06
• Study First Posted: 2019-05-08
• Last Update Posted: 2019-05-08
• Primary Completion: 2021-05
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 9

Inclusion Criteria

1. Histologically confirmed metastatic pancreatic adenocarcinoma
2. Patients aged between 18 and 75
3. ROBO1 expression in malignancy tissues detected by immuno-histochemistry (IHC)
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy greater than 3 months
6. Subjects must have measurable disease as defined by RECIST 1.1 criteria
7. Satisfactory organ and bone marrow function: White blood cell count (WBC) ≥ 3.0×10^9/L, Platelets ≥ 70×10^9/L, Hb ≥ 9.0g/dL, lymphocyte (LY) ≥ 0.7×10^9/L, LY% ≥ 15%, Alb ≥ 2.8g/dL, serum lipase and amylase < 1.5 × upper limit of normal, serum creatinine ≤ 2.5mg/dL, aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 5×upper limit of normal, serum total bilirubin ≤ 2.0mg/dL. These tests must be conducted within 7 days prior to registration
8. Karnofsky score ≥ 60
9. Ability to give informed consent

Exclusion Criteria

1. Previously treated with any gene therapy products
2. Patients who are receiving any other investigational agents
3. Women of child-bearing potential who are pregnant or breastfeeding because of the potentially dangerous effects of the treatment on the fetus or infant
4. Active systemic infections (e.g.: requiring anti-infective treatment), coagulation disorders or any other major medical illnesses
5. Any form of primary immunodeficiency (such as Severe Combined Immunodeficiency Disease)
6. Concurrent opportunistic infections

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)	BiCAR-NK cells (ROBO1 CAR-NK cells)	Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK 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 Radiology, Shanghai Ruijin Hospital; 🇨🇳 Shanghai, China