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| Name | Class |
|---|---|
| Jiangsu Cancer Institute & Hospital | OTHER |
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This open, single-arm,multicenter 2 phase clinical study will treat the patient who have CD19 positive lymphoma with an infusion of the patient's own T cells that have been genetically modified to express a chimeric antigen receptor(CAR)that will bind to tumour cells modified to express the CD19 protein on the cell surface. The study will determine if these modified T cells help the body's immune system eliminate tumour cells .The trial will also study the safety of treatment for CAR-T, how long CAR-T cells stay in the patient's body and the impact on this treatment for survival.
This is an open, single-arm,multicenter 2 phase clinical study to evaluate efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) in the treatment of CD19 positive lymphoma. The study will be conducted using a phaseⅠ/Ⅱdesign the study will have the following sequential phases: part A (screening, leukapheresis, cell product preparation and cytoreductive chemotherapy) and part B (treatment and follow-up). The follow-up period for each participant is approximately 35 months after the final CAR-T infusion. The total duration of the study are expected to be approximately 3 years. A total of 24 patients may be enrolled over a period of 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| single arm | Experimental | Name:The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) Dosage form:injection Dosage:100ml/time Frequency:The first day,the second day,29 days,injection once a day in this three days Duration:Only injection three times |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Chimeric Antigen Receptor T Cell Immunotherapy (CAR-T) | Biological | This study have only one arm that is CAR-T experimental arm. Firstly all participators will be attended the screening, who passed the screening for the treatment of CAR-T cells, the CAR-CD19-modified T cells can recognize and kill tumor cells in the body,follow-up 35 months. |
| Measure | Description | Time Frame |
|---|---|---|
| The objective reaction rate of patients with CD19 positive lymphoma after autologous CAR-T cell therapy. | The objective reaction rate will be determined by the evaluation of CT/PET-CT.Evaluation of the objective reaction rate according to the non-hodgkin's lymphoma curative effect evaluation criteria of international lymphoma group. The objective reaction rate = (complete remission (CR) number + partial remission (PR) number / total number of cases receiving treatment. | up to 90 days |
| Measure | Description | Time Frame |
|---|---|---|
| Progression free survival time | From patients into the group to the interval between disease progression or death. | 3years |
| Overall survival time | From all patients into the group to the interval between death caused by any reason . |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jifeng Feng, Professor | Contact | 13901581264 | fjif@vip.sina.com |
| Name | Affiliation | Role |
|---|---|---|
| Jifeng Feng, Professor | Director of medical oncology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jiangsu Cancer hospital | Nanjing | Jiangsu | 210000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27605551 | Background | Turtle CJ, Hanafi LA, Berger C, Hudecek M, Pender B, Robinson E, Hawkins R, Chaney C, Cherian S, Chen X, Soma L, Wood B, Li D, Heimfeld S, Riddell SR, Maloney DG. Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. Sci Transl Med. 2016 Sep 7;8(355):355ra116. doi: 10.1126/scitranslmed.aaf8621. |
| Label | URL |
|---|---|
| Immunotherapy of non-Hodgkin's lymphoma with a defined ratio of CD8+ and CD4+ CD19-specific chimeric antigen receptor-modified T cells. | View source |
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| ID | Term |
|---|---|
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
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| 3years |
| Patients - -based Quality of Life Evaluation | According to the EORTC quality of life of the core scale criteria QLQ-C30(V3.0) to evaluate patients life quality. | 3years |
| 3°or above incidence rate of serious adverse reaction related to treatment | According to CTCAE v4.0 to evaluate incidence rate of serious adverse reaction. | 3years |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |