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

December 23, 2025 updated by: Shanghai AbelZeta Ltd.

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

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Peking University Third Hospital
        • Contact:
          • Hongmei Jing, M.D.,PhD
      • Beijing, China
        • Completed
        • Beijing Cancer Hospital
      • Beijing, China
        • Recruiting
        • Beijing GoBroad Hospital
        • Contact:
          • Kai Hu, M.D.,PhD
      • Chongqing, China
        • Recruiting
        • Chongqing University Cancer Hospital
        • Contact:
          • Yao Liu, M.D.,PhD
      • Guangzhou, China
        • Recruiting
        • ZhuJiang Hospital of Southern Medical University
        • Contact:
          • Yuhua Li, M.D.,PhD
      • Guangzhou, China
        • Recruiting
        • Guangdong Provincial People's Hospital
        • Contact:
          • Wenyu Li, M.D.,PhD
      • Hangzhou, China
        • Recruiting
        • The First Affiliated Hospital Zhejiang University School of Medicine
        • Contact:
          • Jie Jin, M.D.,PhD
      • Jinan, China
        • Recruiting
        • Cancer Hospital of Shandong First Medical University
        • Contact:
          • Zengjun Li, M.D.,PhD
      • Nanchang, China
        • Recruiting
        • Jiangxi Cancer Hospital
        • Contact:
          • Wuping Li, M.D.,PhD
      • Nanjing, China
        • Recruiting
        • Jiangsu Province Hospital
        • Contact:
          • Lei Fan, M.D.,PhD
      • Shanghai, China
        • Recruiting
        • Ruijin Hospital, Shanghai Jiaotong University School of Medicine
        • Contact:
          • Weili Zhao, M.D., PhD
      • Tianjin, China
        • Recruiting
        • Chinese Academy of Medical Sciences Hematology Hospital
        • Contact:
          • Lugui Qiu, M.D., PhD
        • Contact:
          • Dehui Zou, M.D., PhD
      • Tianjin, China
        • Recruiting
        • Tianjin Medical University Cancer Institute& Hospital
        • Contact:
          • Lanfang Li, M.D.,PhD
      • Zhengzhou, China
        • Recruiting
        • Henan Cancer Hospital
        • Contact:
          • Keshu Zhou, M.D.,PhD
      • Zhengzhou, China
        • Recruiting
        • The First Affiliated Hospital of Zhengzhou University
        • Contact:
          • Mingzhi Zhang, M.D.,PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prizloncabtagene Autoleucel
Prizlon-cel will be intravenously administered as a single infusion after lymphodepletion.
Biological: 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 Names:
  • C-CAR039

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Phase 2: Overall Response Rate (ORR) at 3 months
Time Frame: Up to 3 months after C-CAR039 infusion
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
Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)
Time Frame: Up to 90 days after C-CAR039 infusion
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)
Time Frame: Up to 3 months after C-CAR039 infusion
Based on DLTs rates and overall safety profile
Up to 3 months after C-CAR039 infusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Phase 1b: ORR at 3 months
Time Frame: Up to 3 months after C-CAR039 infusion
Best response rate at 3 months after C-CAR039 infusion, including PR and CR
Up to 3 months after C-CAR039 infusion
Phase 2: Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 2 years after C-CAR039 infusion
Incidence and severity of any AEs
Up to 2 years after C-CAR039 infusion
ORR
Time Frame: Up to 2 years after C-CAR039 infusion
Best response, including PR and CR
Up to 2 years after C-CAR039 infusion
ORR at 6 months
Time Frame: Up to 6 months after C-CAR039 infusion
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)
Time Frame: Up to 2 years after C-CAR039 infusion
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)
Time Frame: Up to 2 years after C-CAR039 infusion
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)
Time Frame: Up to 2 years after C-CAR039 infusion
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)
Time Frame: Up to 2 years after C-CAR039 infusion
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)
Time Frame: Up to 2 years after C-CAR039 infusion
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 Frame: Up to 2 years after C-CAR039 infusion
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)
Time Frame: Up to 28 days after C-CAR039 infusion
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 Frame: Up to 2 years after C-CAR039 infusion
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
Time Frame: Up to 2 years after C-CAR039 infusion
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
Time Frame: Up to 2 years after C-CAR039 infusion
Presence of serum anti-drug (C-CAR039) antibody
Up to 2 years after C-CAR039 infusion
Phase 1b: Incidence and Severity of Adverse Events (AEs)
Time Frame: Up to 2 years after C-CAR039 infusion
Incidence and severity of AEs
Up to 2 years after C-CAR039 infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shanghai AbelZeta Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Weili Zhao, M.D., PhD, Ruijin Hospital
  • Principal Investigator: Lugui Qiu, Chinese Academy of Medical Sciences Hematology Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 22, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 30, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 6, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 31, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 0702-032

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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