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This is a multicenter, single arm, open-label study. The purpose of the study is to evaluate safety of Prizloncabtagene Autoleucel (Prizlon-cel) and establish the recommended Phase 2 dose (RP2D) (Phase 1b) and to evaluate the efficacy of Prizlon-cel (Phase 2) in patients with relapsed or refractory large b-cell lymphoma (LBCL).
The purpose of the study is to evaluate the safety and efficacy of Prizlon-cel. It includes two phases, Phase 1b and Phase 2. In Phase 1b study, RP2D will be determined. The selected dose will be further evaluated in the Phase 2 study. The study includes the following sequential procedures: Screening, Apheresis and CAR-T manufacturing, Baseline, Lymphodepletion, CAR-T infusion, DLT period (Phase 1b) and Follow-up Visit. Subjects will be followed for at least 2 years after Prizlon-cel infusion, with up to 15 years long-term follow-up on a separate study.
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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 | Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens |
|
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) | Incidence and severity of TEAEs , including dose limiting toxicities (DLTs) | Up to 90 days after C-CAR039 infusion |
| Phase 1b: Recommended Phase 2 Dose (R2PD) | Based on DLTs rates and overall safety profile | Up to 3 months after C-CAR039 infusion |
| Phase 2: Overall Response Rate (ORR) at 3 months | Best response rate at 3 months after C-CAR039 infusion, including partial response (PR) and complete response (CR) | Up to 3 months after C-CAR039 infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Phase 1b: Incidence and Severity of Adverse Events (AEs) | Incidence and severity of AEs | Up to 2 years after C-CAR039 infusion |
| Phase 1b: ORR at 3 months | Best response rate at 3 months after C-CAR039 infusion, including PR and CR |
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Inclusion Criteria:
≥ 18 years of age
Histologically confirmed CD19 or CD20 positive B-cell non-Hodgkin lymphoma, including the following neoplasms as defined by the 2016 WHO classification of lymphoid neoplasms:
Relapsed or refractory disease after ≥ 2 lines of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
At least one measurable lesion per the Lugano 2014 Classification
Adequate organ and marrow function
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Weili Zhao, M.D., PhD | Contact | 86-021-64370045 | zwl_trial@163.com | |
| Lugui Qiu, M.D., PhD | Contact | 86-13821266636 | Qiulg@ihcams.ac.cn |
| Name | Affiliation | Role |
|---|---|---|
| Weili Zhao, M.D., PhD | Ruijin Hospital | Principal Investigator |
| Lugui Qiu | Chinese Academy of Medical Sciences Hematology Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Cancer Hospital | Completed | Beijing | China | |||
| Beijing GoBroad Hospital |
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|
| Up to 3 months after C-CAR039 infusion |
| Phase 2: Incidence and Severity of Adverse Events (AEs) | Incidence and severity of any AEs | Up to 2 years after C-CAR039 infusion |
| ORR | Best response, including PR and CR | Up to 2 years after C-CAR039 infusion |
| ORR at 6 months | Best response rate at 6 months after C-CAR039 infusion, including PR and CR | Up to 6 months after C-CAR039 infusion |
| Duration of response (DOR) | The time from the first documented PR or CR to disease progression or death, whichever occurs first | Up to 2 years after C-CAR039 infusion |
| Time to response (TTR) | The time from the date of C-CAR039 infusion to the first documented PR or CR | Up to 2 years after C-CAR039 infusion |
| Progression-free survival (PFS) | The time from the date of C-CAR039 infusion to the date of first documented disease progression or death | Up to 2 years after C-CAR039 infusion |
| Overall survival (OS) | The time from the date of C-CAR039 infusion to the date of death | Up to 2 years after C-CAR039 infusion |
| Maximal plasma concentration (Cmax) | Maximal plasma concentration of C-CAR039 in peripheral blood | Up to 2 years after C-CAR039 infusion |
| Time to reach the maximal plasma concentration (Tmax) | Time to reach the maximal plasma concentration of C-CAR039 in peripheral blood | Up to 2 years after C-CAR039 infusion |
| Area under the curve within 28 days (AUC0-28d) | Area under the curve of C-CAR039 in peripheral blood within 28 days post infusion | Up to 28 days after C-CAR039 infusion |
| Time of last measurable observed concentration (Tlast) | Time of last measurable observed concentration of C-CAR039 in peripheral blood | Up to 2 years after C-CAR039 infusion |
| The B cell percentage changes and CD19/CD20 expression changes in blood | The B cell percentage changes and CD19/CD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion | Up to 2 years after C-CAR039 infusion |
| Anti-drug (C-CAR039) antibody | Presence of serum anti-drug (C-CAR039) antibody | Up to 2 years after C-CAR039 infusion |
| Recruiting |
| Beijing |
| China |
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| Peking University Third Hospital | Recruiting | Beijing | China |
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| Chongqing University Cancer Hospital | Recruiting | Chongqing | China |
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| Guangdong Provincial People's Hospital | Recruiting | Guangzhou | China |
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| Zhujiang Hospital of Southern Medical University | Recruiting | Guangzhou | China |
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| The First Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | China |
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| Cancer Hospital of Shandong First Medical University | Recruiting | Jinan | China |
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| Jiangxi Cancer Hospital | Recruiting | Nanchang | China |
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| Jiangsu Province Hospital | Recruiting | Nanjing | China |
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| Ruijin Hospital, Shanghai Jiaotong University School of Medicine | Recruiting | Shanghai | China |
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| Chinese Academy of Medical Sciences Hematology Hospital | Recruiting | Tianjin | China |
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| Tianjin Medical University Cancer Institute& Hospital | Recruiting | Tianjin | China |
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| Henan Cancer Hospital | Recruiting | Zhengzhou | China |
|
| The First Affiliated Hospital of Zhengzhou University | Recruiting | Zhengzhou | China |
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| ID | Term |
|---|---|
| D012008 | Recurrence |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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