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

NCT05800977 | Recruiting Phase 1

• 1 other identifier: 0702-032
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 15

Brief 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).

Conditions

Relapsed/Refractory Large B-Cell Lymphoma

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (15)

• Phase 1b: Incidence and Severity of Adverse Events (AEs)

  Up to 2 years after C-CAR039 infusion

• Phase 1b: ORR at 3 months

  Up to 3 months after C-CAR039 infusion

• Phase 2: Incidence and Severity of Adverse Events (AEs)

  Up to 2 years after C-CAR039 infusion

• ORR

  Up to 2 years after C-CAR039 infusion

• ORR at 6 months

  Up to 6 months after C-CAR039 infusion

Study Arms (1)

Prizloncabtagene Autoleucel

EXPERIMENTAL

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

Biological: Prizloncabtagene autoleucel

Interventions

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

Also known as: C-CAR039

Prizloncabtagene Autoleucel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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:
• Diffuse large B-cell lymphoma, not otherwise specified (DLBCL, NOS)
• Primary mediastinal large B-cell lymphoma (PMBCL)
• Transformed follicular lymphoma (tFL)
• High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (HGBL-DH/TH)
• High-grade B-cell lymphoma, NOS (HGBL, NOS)
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai AbelZeta Ltd.: lead

Study Sites (15)

Beijing Cancer Hospital

Beijing, China

COMPLETED

Beijing GoBroad Hospital

Beijing, China

RECRUITING

Peking University Third Hospital

Beijing, China

RECRUITING

Chongqing University Cancer Hospital

Chongqing, China

RECRUITING

Guangdong Provincial People's Hospital

Guangzhou, China

RECRUITING

Zhujiang Hospital of Southern Medical University

Guangzhou, China

RECRUITING

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, China

RECRUITING

Cancer Hospital of Shandong First Medical University

Jinan, China

RECRUITING

Jiangxi Cancer Hospital

Nanchang, China

RECRUITING

Jiangsu Province Hospital

Nanjing, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, China

RECRUITING

Tianjin Medical University Cancer Institute& Hospital

Tianjin, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Weili Zhao, M.D., PhD

  Ruijin Hospital

  PRINCIPAL INVESTIGATOR

• Lugui Qiu

  Chinese Academy of Medical Sciences Hematology Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2023
• First Posted: April 6, 2023
• Study Start: February 22, 2023
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): June 30, 2028
• Last Updated: December 31, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (15)