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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B-NHL patients.
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepleting, C-CAR039 infusion, and Follow-up Visit.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prizloncabtagene Autoleucel | Experimental | Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prizloncabtagene Autoleucel | Biological | Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence and severity of adverse events | Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria | Up to 24 months after C-CAR039 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Maximum concentration of C-CAR039 in the peripheral blood (Cmax) | Detect CAR-T copies number by qPCR | Up to 24 Months after C-CAR039 infusion |
| Time to maximum concentration of C-CAR039 in the peripheral blood (Tmax) |
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Criteria: Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Daobin Zhou, PhD&MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Beijing | Beijing/China | 100000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39813680 | Derived | Yu W, Li P, Zhou L, Yang M, Ye S, Zhu D, Huang J, Yao X, Zhang Y, Li L, Zhao J, Zhu K, Li J, Zheng C, Lan L, Wan H, Yao Y, Zhang H, Zhou D, Jin J, Liang A. A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2025 Apr 3;145(14):1526-1535. doi: 10.1182/blood.2024026401. |
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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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Detect CAR-T copies number by qPCR
| Up to 24 Months after C-CAR039 infusion |
| Tlast of C-CAR039 in the peripheral blood after infusio (Tlast) | Detect CAR-T copies number by qPCR | Up to 24 Months after C-CAR039 infusion |
| AUC0h-28d of C-CAR039 in the peripheral blood (AUC0-28d) | Detect CAR-T copies number by qPCR | Up to 28 days after C-CAR039 infusion |
| Overall response rate (ORR) | Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria | Up to 24 Months after C-CAR039 infusion |
| Duration of response (DOR) | The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion | Up to 24 Months after C-CAR039 infusion |
| Progression-free survival (PFS) | The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death | Up to 24 Months after C-CAR039 infusion |
| Overall survival (OS) | The time from C-CAR039 infusion to the date of death | Up to 24 Months after C-CAR039 infusion |
| D008232 |
| Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |