Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer

Ningbo Cancer Hospital

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Precision Cell Immunotherapy; Chemotherapy; Advanced Lung Cancer

Treatments: Drug: Chemotherapy; Biological: Precision Cells

Study type: Interventional

Funder types: Industry

Identifiers

NCT02873416

NBWYKY2016-06-004

Details and patient eligibility

About

To evaluate the safety and effectiveness of cell therapy using Precision Cell Immunotherapy to treat Advanced Lung Cancer.

Eligibility:

Individuals greater than or equal to 18 years of age and less than or equal to 65 years of age who have been diagnosed with Advanced Lung Cancer.

Full description

A total of 40 patients may be enrolled over a period of 1-2 years.

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Age 18~65 years old, male or female;
2. Life expectancy≥6 months;
3. ECOG score: 0-3;
4. Advanced Malignancies (lung cancer) were diagnosed by pathological or clinical physicians;
5. Enough venous channel, no other contraindications to the separation and collection of white blood cells;
6. Laboratory examination: white blood cell≥3 x 10*9/L, blood platelet count≥60 x10*/L,hemoglobin≥85g/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 cells transfusion.

Exclusion criteria

1. Expected Overall survival < 6 months;
2. Patients with uncontrolled hypertension (>160/95mmHg), unstable coronary disease (uncontrolled arrhythmias, unstable angina, decompensated congestive heart failure (> Class II, NYHA), or myocardial infarction within 6 months.
3. Other serious diseases: nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc;
4. Other drugs, or other biological treatment,chemotherapy or radiotherapy are performed within a month.
5. Unable or unwilling to provide informed consent, or fail to comply with the test requirements.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Precision cells combined with Chemotherapy treatment:

Experimental group

Description:

Once a week with a total of six times before 60 days prior to the start of drawing blood. Precision cells：once per 3 weeks with a total of three periods.

Treatment:

Drug: Chemotherapy

Biological: Precision Cells

Chemotherapy

Active Comparator group

Description:

Once a week with a total of six times before 60 days prior to the start of drawing blood.

Treatment:

Drug: Chemotherapy