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 is a study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with relapsed and refractory CD19+/CD20+ NHL.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| double-target CART-19 and 20 | Experimental | Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CART-19 and 20 cells | Biological | Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy. |
|
| Measure | Description | Time Frame |
|---|---|---|
| safety as assessed by the occurrence of study related adverse events | monitor the occurrence of study related adverse events | from the date of recieving intravenous CART cells up to one month |
| Measure | Description | Time Frame |
|---|---|---|
| objective response rate | the proportion of patients benefit from the therapy | 28 days and 3 months after recieving intravenous CART cells |
| peripheral blood CART cell copy number | The highest concentration of CART cells in peripheral blood, the time to reach the highest concentration, and the area under the curve at 28 days after recieving intravenous CART cells |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhihua Yao, M.D. Ph.D | Contact | +8613592622292 | zlyyyaozhihua1260@zzu.edu.cn | |
| Yanyan Liu, M.D. Ph.D | Contact | +8613838176375 | yyliu@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Zhihua Yao, M.D. Ph.D | Henan Cancer Hospital | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university | Recruiting | Zhengzhou | Henan | China |
Not provided
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| ID | Term |
|---|---|
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Cyclophosphamide | Drug | patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2). |
|
| Fludarabine | Drug | Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2). |
|
| from the date of recieving intravenous CART cells up to one month |
| D008206 |
| Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |