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L218CAR19 is a kind of chimeric antigen receptor T-cell immunotherapy targeting CD19 on B cells. The goal of this study is to determine the safety, tolerability, pharmacokinetics, pharmacodynamics and clinical activity of L218CAR19 in patients with B-cell lymphomas who have received at least two lines of systemic treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dose Escalation | Experimental | L218CAR19 is administered via infusion with ascending dose levels to determine the maximum tolerated dose (MTD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| L218CAR19 | Drug | L218CAR19 is intravenously administered at three dose levels. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicity (DLT) | Occurrence of DLTs | Up to 4 weeks |
| Treatment-emergent adverse event (AE) | Incidence of treatment-emergent AEs | Up to 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Quantification of L218CAR19 in peripheral blood | To quantify L218CAR19 in a patient's peripheral blood at different time points | Up to 1 year |
| Time to reach Cmax (Tmax) of L218CAR19 | To identify the time point when the concentration of L218CAR19 reaches maximum in a patient's peripheral blood |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yanyan Liu | Contact | 86 037165587791 | yyliu@zzu.edu.cn | |
| Zheng Yan | Contact | 86 13598097015 | zlyyyanzheng3920@zzu.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Yanyan Liu | Affiliated Cancer Hospital of Zhengzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Affiliated Cancer Hospital of Zhengzhou University | Recruiting | Zhengzhou | Henan | 450008 | China |
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| ID | Term |
|---|---|
| D016393 | Lymphoma, B-Cell |
| ID | Term |
|---|---|
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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| Up to 3 months |
| Area under the curve (AUC) of L218CAR19 | To quantify the cumulative amount of L218CAR19 in a patient's peripheral blood over time | Up to 3 months |
| Clearance (CL) of L218CAR19 | To determine the clearance factor of L218CAR19 in a patient's peripheral blood | Up to 3 months |
| Immunogenic response to L218CAR19 | To evaluate the anti-drug antibodies in response to L218CAR19 administration in a patient's peripheral blood | Up to 1 year |
| Serum cytokine concentrations | To measure the cytokine levels (e.g. TNFa, IL-6, IL-1, IL-2, etc.) in a patient's peripheral blood at different time points | Up to 3 months |
| ORR | To determine the overall (best) objective anti-cancer response by Lugano criteria | Up to 1 year |
| PFS | To evaluate the duration of patient's progression-free survival | Up to 1 year |
| OS | To evaluate the overall duration of patient's survival | Up to 1 year |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |