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

Asclepius Technology

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Pancreatic Cancer

Treatments: Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03941457

AsclepiusTCG03

Details and patient eligibility

About

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.

Enrollment: 9 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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9 participants in 1 patient group

anti-tumor response of BiCAR-NK cells (ROBO1 CAR-NK cells)

Experimental group

Description:

Patients with relapsed and refractory pancreatic cancer of ROBO1 expression will be treated with BiCAR-NK cells (ROBO1 CAR-NK cells).

Treatment:

Biological: BiCAR-NK cells (ROBO1 CAR-NK cells)