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An exploratory clinical study to evaluate the safety and efficacy of NK cells (combined with standard therapy) in the treatment of solid tumor patients
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allogeneic NK(CCT-ANK-11) | Drug | allogeneic natural killer cells |
|
| Measure | Description | Time Frame |
|---|---|---|
| To evaluate the safety and the efficacy | To evaluate the safety and objective remission rate of multiple injections of allogeneic natural killer cells (complete remission [CR] + partial remission [PR]) | 12 months |
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Inclusion Criteria:
(1)White blood cell (WBC) ≥ 3000 cells / mm3. (2)Absolute neutrophil count (ANC) ≥ 1500 cells.
(3)Platelet count (Platelets) ≥ 80000/mm3. (4)Hemoglobin (Hb) ≥ 9g/dl. 9. Patients with appropriate liver and kidney functions:
(1)Urea nitrogen (BUN) ≤ 1.5 times of the upper limit of normal value (ULN).(2)Serum creatinine (serumcreatinine) ≤ 1.5 times of the upper limit of normal value (ULN).(3)Total bilirubin (TB) ≤ 1.5 times of the upper limit of normal value (ULN).(4)Glutamic pyruvic transaminase (ALT or GPT) and glutamic oxaloacetic transaminase (AST or GOT) ≤ 2.5 times the upper limit of normal value (ULN).
10. Patients who have tested negative for syphilis and AIDS. 11.Patient with active hepatitis B, can take antiviral drugs during the trial period.
twelve。 Fertile men and women must use effective contraception within 14 days after signing the informed consent form and within 14 days after the last dose of natural killer cells are infused.
13. At least two forms of birth control must be used, one of which must be a barrier method. Acceptable contraceptive measures include:
(1)Establish oral, injection or implanted hormone contraceptive methods.(2)Placement of intrauterine device (IUD) or intrauterine system (IUS).(4)Barrier method: condom or occlusive cap (contraceptive diaphragm or cervical / uterine cap).
14. The patient agrees to comply to the trial rpotocols.
Exclusion Criteria:
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D004938 | Esophageal Neoplasms |
| D013274 | Stomach Neoplasms |
| D018281 | Cholangiocarcinoma |
| D008175 | Lung Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
| D004066 | Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D013272 | Stomach Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
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