A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma
NCT ID: NCT05800977
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
112 participants
INTERVENTIONAL
2023-02-22
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Prizloncabtagene Autoleucel
Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.
Prizloncabtagene autoleucel
Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens
Interventions
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Prizloncabtagene autoleucel
Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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:
1. Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
2. Primary mediastinal large B-cell lymphoma (PMBCL)
3. Transformed follicular lymphoma (tFL)
4. High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
5. High-grade B-cell lymphoma, NOS (HGBL, NOS)
6. Follicular lymphoma grade 3B (FL3B)
* 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
* Suspected or confirmed central nervous system involvement
* Stroke or convulsion history within 6 months of signing informed consent form (ICF)
* Autoimmune disease, immunodeficiency or diseases requiring immunosuppressants treatment
* Uncontrolled active infection
* Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive human immunodeficiency virus (HIV) antibody; positive syphilis test
* Severe heart, liver, renal or metabolism disease
* Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
* Prior CAR-T therapy
18 Years
ALL
No
Sponsors
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Shanghai AbelZeta Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Weili Zhao, M.D., PhD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Lugui Qiu
Role: PRINCIPAL_INVESTIGATOR
Chinese Academy of Medical Sciences Hematology Hospital
Locations
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Beijing Cancer Hospital
Beijing, , China
Beijing GoBroad Hospital
Beijing, , China
Peking University Third Hospital
Beijing, , China
Chongqing University Cancer Hospital
Chongqing, , China
Guangdong Provincial People's Hospital
Guangzhou, , China
Zhujiang Hospital of Southern Medical University
Guangzhou, , China
The First Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, , China
Cancer Hospital of Shandong First Medical University
Jinan, , China
Jiangxi Cancer Hospital
Nanchang, , China
Jiangsu Province Hospital
Nanjing, , China
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, , China
Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, , China
Tianjin Medical University Cancer Institute& Hospital
Tianjin, , China
Henan Cancer Hospital
Zhengzhou, , China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, , China
Countries
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Central Contacts
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Facility Contacts
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Kai Hu, M.D.,PhD
Role: primary
Hongmei Jing, M.D.,PhD
Role: primary
Yao Liu, M.D.,PhD
Role: primary
Wenyu Li, M.D.,PhD
Role: primary
Yuhua Li, M.D.,PhD
Role: primary
Jie Jin, M.D.,PhD
Role: primary
Zengjun Li, M.D.,PhD
Role: primary
Wuping Li, M.D.,PhD
Role: primary
Lei Fan, M.D.,PhD
Role: primary
Weili Zhao, M.D., PhD
Role: primary
Lugui Qiu, M.D., PhD
Role: primary
Dehui Zou, M.D., PhD
Role: backup
Lanfang Li, M.D.,PhD
Role: primary
Keshu Zhou, M.D.,PhD
Role: primary
Mingzhi Zhang, M.D.,PhD
Role: primary
Other Identifiers
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0702-032
Identifier Type: -
Identifier Source: org_study_id