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| Name | Class |
|---|---|
| The First Hospital of Jilin University | OTHER |
| Hebei Yanda Ludaopei Hospital | OTHER |
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This study aims to evaluate the safety, efficacy and duration of response of CD19 Chimeric Antigen Receptor (CAR) redirected autologous T-cells in patients with high risk, relapsed CD19+ haematological malignancies.
This is a multi-centre, non-randomised, open label Phase I clinical trial of an Advanced Therapy Investigational Medicinal Product named CD19 Chimeric Antigen Receptor (CAR) T-cells (CD19 CAR T-cells) in patients with high risk, relapsed CD19+ haematological malignancies (Leukemia and lymphoma). Following informed consent and registration to the trial, patients will undergo an unstimulated leukapheresis for the generation of the CD19 CAR T-cells. Patients will receive the CD19CAR T-cells following lymphodepleting chemotherapy. The study will evaluate the safety, efficacy and duration of response of the CD19 CAR T-cells in patients with high risk relapsed CD19+ malignancies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental: 1 | Experimental | Acute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
|
| Experimental: 2 | Experimental | Chronic lymphoblastic leukemia with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
|
| Experimental: 3 | Experimental | Non-hodgkin lymphoma treated with chimeric antigen receptor modified T cells(Anti-CD19-CAR) targeting CD19. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Anti-CD19-CAR | Biological | Cells extracted, followed by induction chemotherapy before CD19-CAR infusion (dose escalation.) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events of each patient. | Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0. | 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Survival time of Anti-CD19 CAR T cells in vivo. | To evaluate the presence of circulating CAR T cells with flow cytometry and real time PCR in patient blood. | 3 years |
| Antitumor Effects | Tumor load will be quantified with radiology, bone marrow and/or blood samples dependent on diagnosis. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| gai liyun, doctor | Contact | 086-13269099630 | liyun_gai@doingtimes.com | |
| li gangyi | Contact | 086-13901106501 | gangyi_li@doingtimes.com |
| Name | Affiliation | Role |
|---|---|---|
| li gangyi, master | Beijing Doing Biomedical Co., Ltd. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Beijing | Beijing Municipality | 100142 | China | ||
| The First Affiliated Hospital of Guangzhou Medical University |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Every 3 months post treatment up to 24 months |
| Maximum tolerated dose (MTD) of CD19 targeted CAR T cells. | Maximum tolerated dose (MTD) of CD19 targeted CAR T cells. | 4 weeks |
| Guangzhou |
| Guangdong |
| 510120 |
| China |
| Hebei Yanda Ludaopei Hospital | Sanhe | Hebei | 065200 | China |
|
| First Affiliated Hospital of Henan University of Science and Technology | Luoyang | Henan | 471003 | China |
| The First Affiliated Hospital of Zhengzhou University | Zhengzhou | Henan | 450052 | China |
| Huai'An First People'S Hospital | Huaian | Jiangsu | 223300 | China |
| Nanjing Drum Tower Hospital | Nanjing | Jiangsu | 210008 | China |
| First Hospital of Jilin University | Changchun | Jilin | 130021 | China |
| Shanxi Dayi Hospital | Taiyuan | Shanxi | 030000 | China |
| Tianjin people's hospital | Tianjin | Tianjin Municipality | 300121 | China |
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| Hangzhou Cancer Hospital | Hangzhou | Zhejiang | 310002 | China |
| Beijing DOING Biomedical Co., Ltd | Beijing | 100021 | China |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |