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Relapsed/Refractory Large B-Cell LymphomaPhase 1/2ELEVATIONNCT05800977

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

A Phase 1/2 study testing Prizloncabtagene autoleucel in people with Relapsed/Refractory Large B-Cell Lymphoma, run by Shanghai AbelZeta Ltd. at 15 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Prizloncabtagene autoleucel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
112 participants
Where
15 sitesChina
Study dates
22 Feb 2023to 30 Jun 2028
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • ≥ 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)
Show all 11Show fewer
  • 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

Who cannot join

  • 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
Show all 9Show fewer
  • Severe heart, liver, renal or metabolism disease
  • Inadequate wash-out time for previous anti-tumor treatments prior to apheresis
  • Prior CAR-T therapy

Trial locations and contacts

15 sites in 1 country. Contact the study team or a site near you to ask about taking part.

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

15 sites in 1 country

China15 sites, 14 recruiting

  • Beijing Cancer Hospital

    Beijing

    Completed

  • Beijing GoBroad Hospital

    Beijing

    Kai Hu, M.D.,PhD

    Recruiting

  • Peking University Third Hospital

    Beijing

    Hongmei Jing, M.D.,PhD

    Recruiting

  • Chongqing University Cancer Hospital

    Chongqing

    Yao Liu, M.D.,PhD

    Recruiting

  • Guangdong Provincial People's Hospital

    Guangzhou

    Wenyu Li, M.D.,PhD

    Recruiting

  • Zhujiang Hospital of Southern Medical University

    Guangzhou

    Yuhua Li, M.D.,PhD

    Recruiting

  • The First Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou

    Jie Jin, M.D.,PhD

    Recruiting

  • Cancer Hospital of Shandong First Medical University

    Jinan

    Zengjun Li, M.D.,PhD

    Recruiting

  • Jiangxi Cancer Hospital

    Nanchang

    Wuping Li, M.D.,PhD

    Recruiting

  • Jiangsu Province Hospital

    Nanjing

    Lei Fan, M.D.,PhD

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    Weili Zhao, M.D., PhD

    Recruiting

  • Chinese Academy of Medical Sciences Hematology Hospital

    Tianjin

    Lugui Qiu, M.D., PhD

    Dehui Zou, M.D., PhD

    Recruiting

  • Tianjin Medical University Cancer Institute& Hospital

    Tianjin

    Lanfang Li, M.D.,PhD

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    Keshu Zhou, M.D.,PhD

    Recruiting

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

    Mingzhi Zhang, M.D.,PhD

    Recruiting

Other trials in China

About this study

Official title: 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).

Read the 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.

Being tested
Prizloncabtagene autoleucel
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Prizloncabtagene autoleucelBiological

    Also called C-CAR039

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

Study groups in NCT05800977
Study groupRoleWhat they receive
Prizloncabtagene AutoleucelExperimentalPrizlon-cel will be intravenously administered as a single infusion after lymphodepletion.
Receives: Biological: Prizloncabtagene autoleucel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs)

    Incidence and severity of TEAEs , including dose limiting toxicities (DLTs)

    Measured: Up to 90 days after C-CAR039 infusion

  2. Phase 1b: Recommended Phase 2 Dose (R2PD)

    Based on DLTs rates and overall safety profile

    Measured: Up to 3 months after C-CAR039 infusion

  3. 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)

    Measured: Up to 3 months after C-CAR039 infusion

Secondary outcomes (15)

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

    Incidence and severity of AEs

    Measured: Up to 2 years after C-CAR039 infusion

  2. Phase 1b: ORR at 3 months

    Best response rate at 3 months after C-CAR039 infusion, including PR and CR

    Measured: Up to 3 months after C-CAR039 infusion

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

    Incidence and severity of any AEs

    Measured: Up to 2 years after C-CAR039 infusion

  4. ORR

    Best response, including PR and CR

    Measured: Up to 2 years after C-CAR039 infusion

  5. ORR at 6 months

    Best response rate at 6 months after C-CAR039 infusion, including PR and CR

    Measured: Up to 6 months after C-CAR039 infusion

  6. Duration of response (DOR)

    The time from the first documented PR or CR to disease progression or death, whichever occurs first

    Measured: Up to 2 years after C-CAR039 infusion

  7. Time to response (TTR)

    The time from the date of C-CAR039 infusion to the first documented PR or CR

    Measured: Up to 2 years after C-CAR039 infusion

  8. Progression-free survival (PFS)

    The time from the date of C-CAR039 infusion to the date of first documented disease progression or death

    Measured: Up to 2 years after C-CAR039 infusion

  9. Overall survival (OS)

    The time from the date of C-CAR039 infusion to the date of death

    Measured: Up to 2 years after C-CAR039 infusion

  10. Maximal plasma concentration (Cmax)

    Maximal plasma concentration of C-CAR039 in peripheral blood

    Measured: Up to 2 years after C-CAR039 infusion

  11. Time to reach the maximal plasma concentration (Tmax)

    Time to reach the maximal plasma concentration of C-CAR039 in peripheral blood

    Measured: Up to 2 years after C-CAR039 infusion

  12. Area under the curve within 28 days (AUC0-28d)

    Area under the curve of C-CAR039 in peripheral blood within 28 days post infusion

    Measured: Up to 28 days after C-CAR039 infusion

  13. Time of last measurable observed concentration (Tlast)

    Time of last measurable observed concentration of C-CAR039 in peripheral blood

    Measured: Up to 2 years after C-CAR039 infusion

  14. The B cell percentage changes and CD19/CD20 expression changes in blood

    The B cell percentage changes and CD19/CD20 expression changes in blood by flow cytometry assay before and after C-CAR039 infusion

    Measured: Up to 2 years after C-CAR039 infusion

  15. Anti-drug (C-CAR039) antibody

    Presence of serum anti-drug (C-CAR039) antibody

    Measured: Up to 2 years after C-CAR039 infusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start22 Feb 2023
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion30 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
112 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05800977
Sponsor's protocol ID
0702-032
Acronym
ELEVATION
Status last verified
Dec 2025
First submitted
24 Mar 2023
Last updated
31 Dec 2025
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Prizloncabtagene autoleucel in people with Relapsed/Refractory Large B-Cell Lymphoma, run by Shanghai AbelZeta Ltd. at 15 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Weili Zhao, M.D., PhD (86-021-64370045, zwl_trial@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase 1b: Incidence and Severity of Treatment-emergent Adverse Events (TEAEs) (time frame: Up to 90 days after C-CAR039 infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05800977.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.

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