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Precision Cell Immunotherapy Combined With Chemotherapy in Advanced Lung Cancer

N

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)

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

Trial contacts and locations

1

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Central trial contact

Bi Wang

Data sourced from clinicaltrials.gov

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