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This is a single arm study to evaluate the efficacy and safety of CD19-targeted CAR-T cells therapy for patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma.
There are limited options for treatment of relapse/refractory CD19+ B Cell Leukemia and Lymphoma. CD19 is expressed on most CD19+ B Cell Leukemia and Lymphoma cells so it is an ideal target for CAR-T. In this study, investigators will evaluate the safety and efficacy of CAR-T targeting CD19 in patients with relapsed/refractory CD19+ B Cell Leukemia and Lymphoma. The primary goal is safety and efficiency assessment, including adverse events and disease status after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CD19 CAR-T cells treat | Experimental | Patients will be be treated with CD19 CAR-T cells |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CD19 CAR-T cells | Biological | A single infusion of CD19-CAR-T cells will be administered intravenously. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events that related to treatment | Therapy-related adverse events will be recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0) | 2 years |
| The response rate of CD19 CAR-T treatment in patients with relapse/refractory CD19+ B Cell Leukemia and Lymphoma that treatment by CD19 CAR-T cells therapy | The response rate of CD19 CAR-T treatment will be recorded and assessed according to the National Comprehensive Cancer Network Guideline | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of CD19 CAR-T cells in bone marrow and peripheral blood | In vivo (bone marrow and peripheral blood) rate of CD19 CAR-T cells were determined by means of flow cytometry | 2 years |
| Quantity of CD19 CAR copies in bone marrow and peripheral blood |
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Inclusion Criteria:
Signed written informed consent;
Diagnose as relapsed /refractory B Cell Leukemia and Lymphoma, and meet one of the following conditions:
For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)ï¼›
Evidence for cell membrane CD19 expression;
All genders, ages: 3 to 75 yearsï¼›
The expect time of survive is above 12 weeks;
KPS>60ï¼›
No serious mental disorders ;
Left ventricular ejection fraction ≥50%
Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
Sufficient renal function defined by creatinine clearance≤2 x ULN;
Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
With single or venous blood collection standards, and no other cell collection contraindications;
Ability and willingness to adhere to the study visit schedule and all protocol requirements.
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhi Yang, PhD | Contact | 86-13206140093 | yangzhi@precision-biotech.com | |
| Yingzi Zhang | Contact | 86-18623351275 | yingzi6526@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Cheng Qian, PhD | Chongqing University Cancer Hospital | Principal Investigator |
| Ying Xiang, MD | Chongqing University Cancer Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chongqing University Cancer Hospital | Recruiting | Chongqing | Chongqing Municipality | China |
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| ID | Term |
|---|---|
| D007938 | Leukemia |
| D008223 | Lymphoma |
| D015448 | Leukemia, B-Cell |
| D015451 | Leukemia, Lymphocytic, Chronic, B-Cell |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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In vivo (bone marrow and peripheral blood) quantity of CD19 CAR copies were determined by means of qPCR
| 2 years |
| Cellular kinetics of CD19 positive cells in bone marrow | In vivo (bone marrow) rate and quantity of CD19 positive cells were determined by means of flow cytometry | 1 years |
| Levels of Cytokines in Serum | In vivo (Serum) quantity of cytokines | 3 months |
| Duration of Response (DOR) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma | DOR will be assessed from the first assessment of CR/CRi to the first assessment of recurrence or progression of the disease or death from any cause (censored) | 2 years |
| Progress-free survival(PFS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma | PFS will be assessed from the first CAR-T cell infusion to death from any cause or the first assessment of progression (censored) | 2 years |
| Overall survival(OS) of CD19 CAR-T treatment in patients with refractory/relapsed CD19+ B Cell Leukemia and Lymphoma | OS will be assessed from the first CAR-T cell infusion to death from any cause (censored) | 2 years |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
| D007945 | Leukemia, Lymphoid |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |