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| Name | Class |
|---|---|
| Shanghai AbelZeta Ltd. | INDUSTRY |
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This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.
This is a single-arm, open label, "3+3" dose escalation, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled.
Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months.
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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 |
|---|---|---|
| MTD | maximum tolerated dose or clinical recommended dose | Up to 24 months after C-CAR039 infusion |
| DLT | Dose limiting toxicity | Up to 28 days after C-CAR039 infusion |
| AE/SAE/AESI | adverse events (AE), serious adverse event (SAE), adverse events of sepical interest (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate. | Up to 24 months after C-CAR039 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| C-CAR039 CAR expansion and persistence | After C-CAR039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo, including Cmax, Tmax, AUC0-28day, Tlast | Up to 24 Months after C-CAR039 infusion |
| Overall response rate (ORR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jie Jin, PhD&MD | First Affiliated Hospital of Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital, College of Medicine, Zhejiang University | Hangzhou | Zhejiang | 310003 | 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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None (Open Label)
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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 |