Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Shenzhen Institute for Innovation and Translational Medicine | OTHER |
| Guangzhou First People's Hospital | OTHER |
| First People's Hospital of Foshan | OTHER |
Not provided
Not provided
Not provided
Not provided
Autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) will be infused back to patients with refractory /relapsed B cell malignancies, including lymphoma and leukemia. The patients will be monitored after infusion of anti-CD19 CAR-transduced T cells for safety,adverse events, persistence of anti-CD19 CAR-transduced T cells and treatment efficacy.
Despite progress has been made to date in the treatment of patients with B cell malignancies, including leukemia and lymphoma, many patients with relapsed or refractory diseases do not respond to the standard treatments. It has been shown that anti-CD19 CAR-transduced T cells may be an effective approach to treat the relapsed or refractory diseases. The procedure involves collecting PBMCs from the patients and modifying the T cells to attack the malignant B cells. In this trial, autologous T cells engineered to express an anti-CD19 chimeric antigen receptor (CAR) containing the signaling domains of CD28 or 4-1BB and CD3-zeta will be infused back to patients with B cell malignancies, including lymphoma and leukemia. The patients will be pretreated with a lymphodepleting preconditioning regimen before the infusion of anti-CD19 CAR T cells, and will be monitored for safety, adverse events, persistence of anti-CD19 CAR-transduced T cells and the treatment efficacy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Anti-CD19 CAR transduced T cells | Experimental | Patients will receive a lymphodepleting preconditioning regimen with Fludarabine and Cyclophosphamide followed by anti-CD19 CAR-transduced T cells. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drugs and anti-CD19 CAR transduced T cells | Combination Product | Drug: Fludarabine On days -4 through -2, Fludarabine 30mg/m2 (IV) will be infused over 30 minutes. Drug: Cyclophosphamide On days -4 through -2, Cyclophosphamide 300-500mg/m2 IV will be infused over 60 minutes followed by fludarabine. Biological: Anti-CD19-CAR T cells On day 0, cells will be infused intravenously IV over 20 - 30 minutes. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse Events | To evaluate the safety and feasibility of the administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies. | 24 months |
| Number of participants with clinical responses | To determine if the treatment regimen can result in clinical regression of B cell malignancies in the patients as described above. | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of overall survial | To evaluate overall survial(OS) after administration of anti-CD19 CAR transduced T cells in patients with refractory /relapsed CD19+ B cell malignancies. | 24 months |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ying Feng, MD | Contact | 0086 13602723030 | fyzlply@163.com | |
| Mingjun Wang, MD | Contact | 0086 15814723218 | mingjunw429@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Ying Feng, MD | Second Affiliated Hospital of Guangzhou Medical University | Study Director |
| Mingjun Wang, MD | Shenzhen Institute for Innovation and Translational Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Hematology, Dongguan People's Hospital | Recruiting | Dongguan | Guangdong | China |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Dongguan People's Hospital |
| OTHER_GOV |
| The First Affiliated Hospital of Guangdong Pharmaceutical University | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Department of Hematology, the First People's Hospital of Foshan | Recruiting | Foshan | Guangdong | China |
|
| Department of Hematology, Guangzhou First People's Hospital | Recruiting | Guangzhou | Guangdong | China |
|
| Department of Hematology, The First Affiliated Hospital of Guangdong Pharmaceutical University | Recruiting | Guangzhou | Guangdong | China |
|
| Department of Hematology,the Second Affiliated Hospital of Guangzhou Medical University | Recruiting | Guangzhou | Guangdong | China |
|
| ID | Term |
|---|---|
| D054198 | Precursor Cell Lymphoblastic Leukemia-Lymphoma |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| D008223 | Lymphoma |
| ID | Term |
|---|---|
| D007945 | Leukemia, Lymphoid |
| D007938 | Leukemia |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D015448 | Leukemia, B-Cell |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
Not provided
Not provided
Not provided