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The purpose of the study is to evaluate the safety and tolerability of B019 in subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| B019 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| B019 | Biological | B019: Intravenous infusion, 1.0×10^6 CAR T cell/kg-10.0×10^6 CAR T cell/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| (一) Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Incidence of Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | Approximately 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| The overall response rate (ORR) | Tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1. | 3 months |
| Overall Survival (OS) | Determination of the overall survival times of all patients. |
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Inclusion Criteria:
3. Liver, kidney, lung and heart function meet requirements; 4. Expected survival >3 months; 5. Women of childbearing age and all post-adolescent male participants are willing to use highly effective contraceptive methods within 1 year after the infusion of B019 injection. At the same time, the subject should promise not to donate eggs or sperm for assisted reproduction for 1 year after the cell infusion.
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Exclusion Criteria:
4. Subjects who received therapy abandoned in protocal before PBMC (peripheral blood mononuclear cells) collection or before B019 injection; 5.Active other malignancy in 5 years. 6. Subjects who are positive for any of HBsAg, HBeAg, HBeAb, HBcAb, HCV-RNA, HIV EBV DNA, CMV DNA, HTLV-ab.
7. Other situations deemed inappropriate for participation in this study by the investigator.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jing Chen | Contact | 0086-021-38626161 | chenjing@scmc.com.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | China |
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| Approximately 2 years |
| PK(Pharmacokinetics):Tmax | Time to peak plasma concentration (Tmax) | Approximately 2 years |
| PK(Pharmacokinetics):Cmax | Maximum serum concentration(Cmax) | Approximately 2 years |
| Jiangxi Province pediatric hospital | Recruiting | Nanchang | China |
|
| The First Affiliated Hospital of Nanchang University | Recruiting | Nanchang | China |
|
| Children's Hospital of Shanghai | Recruiting | Shanghai | China |
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| Shanghai Children's Medical Center | Recruiting | Shanghai | China |
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| Children's Hospital of Soochow University | Recruiting | Suzhou | China |
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| Tongji Hospital | Recruiting | Wuhan | China |
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| The Affiliated Hospital of Xuzhou Medical University | Recruiting | Xuzhou | China |
|
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D002051 | Burkitt Lymphoma |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D020031 | Epstein-Barr Virus Infections |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D014412 | Tumor Virus Infections |
| D016393 | Lymphoma, B-Cell |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
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