RecruitingPhase 1Phase 2NCT05800977

A Study of C-CAR039 (Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma

A Phase 1b/2 Study of a Anti-CD19/CD20 Bispecific CAR-T Therapy (C-CAR039/Prizloncabtagene Autoleucel) in Patients With Relapsed/Refractory Large B-Cell Lymphoma


Sponsor

Shanghai AbelZeta Ltd.

Enrollment

112 participants

Start Date

Feb 22, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is studying a CAR T-cell therapy called C-CAR039 (prizloncabtagene autoleucel) for patients with large B-cell lymphoma that has returned or stopped responding to treatment. CAR T-cell therapy uses your own immune cells, which are re-engineered in a lab to find and destroy cancer cells. **You may be eligible if:** - You are 18 or older - You have been diagnosed with large B-cell lymphoma (such as DLBCL, PMBCL, or transformed follicular lymphoma) confirmed by biopsy - Your cancer is CD19 or CD20 positive - Your lymphoma has relapsed or not responded after at least 2 prior treatments, or has come back after a stem cell transplant - You have at least one measurable tumor - Your organs (heart, liver, kidneys) are functioning well enough **You may NOT be eligible if:** - You have previously had an allogeneic (donor) stem cell transplant, or had an autologous transplant within the last 12 weeks - Cancer has spread to the brain or spinal cord - You have had a stroke or seizure in the past 6 months - You have an active autoimmune disease or HIV/hepatitis B/C infection - You have uncontrolled active infection Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALPrizloncabtagene autoleucel

Prizlon-cel is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD19 and CD20 antigens


Locations(15)

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

View Full Details on ClinicalTrials.gov

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NCT05800977


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