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NCT Number: NCT05800977

A Study of 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).

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Key information

Conditions

Relapsed/Refractory Large B-cell Lymphoma Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Beijing Cancer Hospital, Beijing, China

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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

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

Treatment and study plan

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

Other names: C-CAR039

Primary outcomes

  1. 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)

  2. 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

  3. 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)

Secondary outcomes

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

    Time frame: Up to 2 years after C-CAR039 infusion

    Incidence and severity of AEs

  2. 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

  3. 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

  4. ORR

    Time frame: Up to 2 years after C-CAR039 infusion

    Best response, including PR and CR

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Maximal plasma concentration (Cmax)

    Time frame: Up to 2 years after C-CAR039 infusion

    Maximal plasma concentration of C-CAR039 in peripheral blood

  11. 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

  12. 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

  13. 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

  14. 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

  15. Anti-drug (C-CAR039) antibody

    Time frame: Up to 2 years after C-CAR039 infusion

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

Study contacts

Contact information is provided by the study sponsor or research team.

Lugui Qiu, M.D., PhD

CONTACT

[email protected]

86-13821266636

Weili Zhao, M.D., PhD

CONTACT

[email protected]

86-021-64370045

Sponsors and collaborators

Lead sponsor

Shanghai AbelZeta Ltd.

Industry

Registry information

Official study 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

Acronym: ELEVATION

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Apr 6, 2023
Registry last updated
Dec 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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