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CompletedNCT04655677Updated May 23, 2025

A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma

A Phase 1 interventional study of Prizloncabtagene Autoleucel in B-cell Non-Hodgkin's Lymphoma, sponsored by Peking Union Medical College Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-23.

Sponsored by Peking Union Medical College Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 70 Years
Sex
All
01

Study summary

This is a single-center, open-label study to evaluate the safety and efficacy of C-CAR039 in relapsed and/or refractory B-NHL patients.

Read the detailed description

The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepleting, C-CAR039 infusion, and Follow-up Visit.

02

Conditions studied

  • B-cell Non-Hodgkin's Lymphoma

Keywords

  • CD19/CD20-directed CAR-T cells
03

In context

Lymphoma

5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.

This study's enrollment of 10 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Peking Union Medical College Hospital is the lead sponsor of 1,115 studies on the registry; 463 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Criteria: Inclusion Criteria:

  1. Age 18-70 years (include 18 and 70), male or female;
  2. Expected survival ≥ 12 weeks
  3. ECOG score 0-2
  4. CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL
  5. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT);
  6. For CD20-positive subjects, they should have received at least one regimen containing anti-CD20-targeted therapy (such as rituximab). If they do not complete the regimen due to intolerance, the cause of intolerance should be recorded;
  7. No contraindications of apheresis.
  8. At least one measurable lesion according to Lugano 2014 criteria;
  9. Adequate organ and bone marrow function
  10. The patient volunteered to participate in the study and signed the Informed Consent.

Exclusion Criteria:

  1. Malignant tumors other than diffuse large B-cell lymphoma, follicular lymphoma and mantle cell lymphoma within 5 years before screening, except fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical operation and breast ductal carcinoma in situ after radical operation;
  2. Active HIV, HBV, HCV or treponema pallidum infection;
  3. Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
  4. Any other uncontrolled active disease that hinders participation in the trial;
  5. Any situation that the investigator believes would compromise the safety of the subject or interfere with the purpose of the study;
  6. Female subjects who have been pregnant or breastfeeding, or who plan to conceive during or within 1 year after treatment, or male subjects' partner plans to conceive within 1 year after C-CAR039 infusion;
  7. Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
  8. Patients who have previously been infected with tuberculosis.
  9. Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
  10. Patients with central nervous system involvement;
  11. Any systemic antitumor therapy performed within 2 weeks before enrollment;
  12. Those with medical conditions that prevent them from signing the written informed consent or from complying with the study procedures; or those who are unwilling or unable to comply with the study requirements;
  13. Other conditions was considered unsuitable for enrollment by the investigator.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • Experimental
    Prizloncabtagene Autoleucel

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

    Biological: Prizloncabtagene Autoleucel

Interventions

  • BiologicalPrizloncabtagene Autoleucel

    Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously

    Also known as: C-CAR039

06

What researchers measure

Primary outcomes

  1. Incidence and severity of adverse events

    Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria

    Time frame: Up to 24 months after C-CAR039 infusion

Secondary outcomes

  1. Maximum concentration of C-CAR039 in the peripheral blood (Cmax)

    Detect CAR-T copies number by qPCR

    Time frame: Up to 24 Months after C-CAR039 infusion

  2. Time to maximum concentration of C-CAR039 in the peripheral blood (Tmax)

    Detect CAR-T copies number by qPCR

    Time frame: Up to 24 Months after C-CAR039 infusion

  3. Tlast of C-CAR039 in the peripheral blood after infusio (Tlast)

    Detect CAR-T copies number by qPCR

    Time frame: Up to 24 Months after C-CAR039 infusion

  4. AUC0h-28d of C-CAR039 in the peripheral blood (AUC0-28d)

    Detect CAR-T copies number by qPCR

    Time frame: Up to 28 days after C-CAR039 infusion

  5. Overall response rate (ORR)

    Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria

    Time frame: Up to 24 Months after C-CAR039 infusion

  6. Duration of response (DOR)

    The time from the date of first response (PR or better) to the date of disease progression or death after C-CAR039 infusion

    Time frame: Up to 24 Months after C-CAR039 infusion

  7. Progression-free survival (PFS)

    The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death

    Time frame: Up to 24 Months after C-CAR039 infusion

  8. Overall survival (OS)

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

    Time frame: Up to 24 Months after C-CAR039 infusion

07

Study locations

1 site
  • Peking Union Medical College Hospital
    Beijing, Beijing/China 100000, China
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04655677
Lead sponsor
Peking Union Medical College Hospital
Collaborators
Shanghai AbelZeta Ltd.
Responsible party
Yan Zhang, MD (Chief Physician, Peking Union Medical College Hospital) — Principal investigator
First posted
Dec 7, 2020
Start date
Oct 30, 2020
Primary completion
Feb 28, 2024
Completion
Jun 30, 2024
Last update
May 23, 2025

Study contacts

Daobin Zhou, PhD&MD
principal investigator · Peking Union Medical College Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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