Pancreatic Cancer
Conditions
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.
Interventions
BIOLOGICALBiCAR-NK cells (ROBO1 CAR-NK cells)
The subject will be observed for any side effects during this time and all the adverse events will be recorded.
Sponsors
Asclepius Technology Company Group (Suzhou) Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
China
Contacts
Primary ContactGuangfu Li
Backup ContactXianfeng Feng
Outcome results
None listed