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CompletedNCT04696432Updated May 28, 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 Non-Hodgkin's B-cell Lymphoma, sponsored by Tianjin Medical University Cancer Institute and Hospital. Completed at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-28.

Sponsored by Tianjin Medical University Cancer Institute and Hospital · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
7
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

This is a single-arm, open label, phase I study to evaluate the safety and preliminary efficacy of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. 10 patients are planned to be enrolled. Following consent, enrolled subjects will undergo a leukapheresis procedure to collect autologous mononuclear cells for manufacture of C-CAR039. Following manufacture of the drug product, subjects will receive lymphodepleting therapy with fludarabine and cyclophosphamide prior to C-CAR039 infusion. All subjects who have received C-CAR039 infusion will be followed for up to 24 months

02

Conditions studied

  • Non-Hodgkin's B-cell 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 7 is below the median of 40 across 4,508 interventional studies indexed under Lymphoma.

Browse Lymphoma studies →

Lead sponsor

Tianjin Medical University Cancer Institute and Hospital is the lead sponsor of 484 studies on the registry; 286 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

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

Exclusion Criteria:

  1. Malignant tumors other than B-NHL within 5 years prior to screening, except cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;
  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 uncontrolled active disease that prevents participation in the trial
  5. Any situation that the investigator believes will harm the safety of the subjects 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 been previously 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
7 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 (AE)

    Incidence and severity of adverse events, including AE, Serious AE, AE of special interset (AESI)

    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. The last of C-CAR039 in the peripheral blood after infusion (Tlast)

    Detect CAR-T copies number by qPCR

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

  3. AUC0-28d 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

  4. Time to reach the maximum plasma concentration (Tmax)

    Detect CAR-T copies number by qPCR

    Time frame: Up to 24 Months 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
  • Tianjin Medical University Cancer Institute & Hosipital
    Tianjin, Tianjin 300060, 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 28, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04696432
Lead sponsor
Tianjin Medical University Cancer Institute and Hospital
Collaborators
Shanghai AbelZeta Ltd.
Responsible party
Sponsor
First posted
Jan 6, 2021
Start date
Nov 27, 2020
Primary completion
Jul 31, 2023
Completion
Dec 30, 2023
Last update
May 28, 2025

Study contacts

Lanfang Li, PhD&MD
principal investigator · Tianjin Medical University Cancer Institute & Hosipital

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 Dec 2023. You cannot join it, but the record below documents what was studied.

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