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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-22

Study Completion Date

2028-06-30

Brief Summary

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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).

Detailed Description

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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.

Conditions

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Relapsed/Refractory Large B-Cell Lymphoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Prizloncabtagene Autoleucel

Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.

Group Type EXPERIMENTAL

Prizloncabtagene autoleucel

Intervention Type BIOLOGICAL

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

Intervention Type BIOLOGICAL

Other Intervention Names

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C-CAR039

Eligibility Criteria

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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:

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

* Prior allogeneic hematopoietic stem cell transplantation (HSCT) at anytime, or ASCT within 12 weeks prior to apheresis
* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai AbelZeta Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status COMPLETED

Beijing GoBroad Hospital

Beijing, , China

Site Status RECRUITING

Peking University Third Hospital

Beijing, , China

Site Status RECRUITING

Chongqing University Cancer Hospital

Chongqing, , China

Site Status RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, , China

Site Status RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, , China

Site Status RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, , China

Site Status RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, , China

Site Status RECRUITING

Jiangxi Cancer Hospital

Nanchang, , China

Site Status RECRUITING

Jiangsu Province Hospital

Nanjing, , China

Site Status RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, , China

Site Status RECRUITING

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, , China

Site Status RECRUITING

Tianjin Medical University Cancer Institute& Hospital

Tianjin, , China

Site Status RECRUITING

Henan Cancer Hospital

Zhengzhou, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weili Zhao, M.D., PhD

Role: CONTACT

Phone: 86-021-64370045

Email: [email protected]

Lugui Qiu, M.D., PhD

Role: CONTACT

Phone: 86-13821266636

Email: [email protected]

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