Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This study will analyze and evaluate the following items:
Subjects from 18 to 75 years of age who are diagnosed with a solid tumor including pancreatic cancer, lung cancer, breast cancer, ovarian cancer and colon cancer, and for whom standard treatments are not effective, may be eligible for this study. Participants undergo the following procedures:
Peripheral blood will be collected from a vein of arm. Peripheral blood mononuclear cells(PBMC) will be isolated and purified for NK manufacturing. After 14~21 days cultivation, activated NK will be harvested and formulated for clinical administration.
Subjects will receive NK cell treatment by intravenous infusion. The frequency is once every 3 or 4 weeks for the first 3 months. Participants who respond well after 3 months may be eligible to continue NK cell therapy; and those not may receive NK therapy combined with chemotherapy and/or targeted drugs, or chemotherapy/targeted drugs alone.
Evaluations during therapy including:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NK cells | Experimental | Activated NK from peripheral blood and/or umbilical cord blood(UCB) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Activated NK | Biological | Cell suspension |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of toxicity induced by NK infusion | The incidence of toxicity within each infusion within 6 months after NK administration | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Objective-response rate (ORR) | Objective-response rate (ORR): defined as the proportion of patients who achieve partial response (PR) or complete response (CR) per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 at any time on study. | 6 months after 6 infusions of NK administration |
| Persistence of NK |
Not provided
Inclusion Criteria:
Age from 18 to 75 years (including boundary values);
Diagnosed with histologically and cellularly confirmed cancer of lung, breast, pancreas, ovary, or colon;
At least 8 weeks since any prior systemic therapy to treat the underlying malignancy (standard or investigational);
Life expectancy > 6 months, and performance status(KPS)> 60 points;
Organ functions meet the following criteria:
No severe infections.
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiguo Chen, PhD | Contact | 86-10-83198889 | chenzhiguo@gmail.com | |
| Yu Zhao, PhD | Contact | 86-10-83198274 |
| Name | Affiliation | Role |
|---|---|---|
| Zhiguo Chen, PhD | Xuanwu Hospital, Beijing | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xuanwu Hospital | Recruiting | Beijing | Beijing Municipality | 100053 | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D001943 | Breast Neoplasms |
| D003110 | Colonic Neoplasms |
| D010190 | Pancreatic Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Duration of NK persistence: defined as duration from Day 1 to the time when the NK level goes back to stable level |
| Day 0, Day 7, Day30, Day 60, Day 90, Day 180 |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System 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 |