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Completed

NCT Number: NCT04655677

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

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Peking Union Medical College Hospital

Beijing, Beijing/China, 100000, China

About this study

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

Who can participate

Healthy volunteers accepted: No

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

Criteria: Inclusion Criteria:

  • Age 18-70 years (include 18 and 70), male or female;
  • Expected survival ≥ 12 weeks
  • ECOG score 0-2
  • CD19 or CD20 positive B-NHL confirmed by cytology or histology according to WHO2016 criteria, including DLBCL, PMBCL, tFL, FL and MCL
  • Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT);
  • 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;
  • No contraindications of apheresis.
  • At least one measurable lesion according to Lugano 2014 criteria;
  • Adequate organ and bone marrow function
  • The patient volunteered to participate in the study and signed the Informed Consent.

Exclusion criteria

  • 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;
  • Active HIV, HBV, HCV or treponema pallidum infection;
  • Any instability of systemic disease, including but not limited to active infection (except local infection), severe cardiac, liver, kidney, or metabolic disease need therapy
  • Any other uncontrolled active disease that hinders participation in the trial;
  • Any situation that the investigator believes would compromise the safety of the subject or interfere with the purpose of the study;
  • 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;
  • Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
  • Patients who have previously been infected with tuberculosis.
  • Administered Corticosteroids and/or other immunosuppressants within 7 days before apheresis. and 5 days before the infusion of C-CAR039;
  • Patients with central nervous system involvement;
  • Any systemic antitumor therapy performed within 2 weeks before enrollment;
  • 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;
  • Other conditions was considered unsuitable for enrollment by the investigator.

Treatment and study plan

Prizloncabtagene autoleucel

Biological

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

Other names: C-CAR039

Primary outcomes

  1. Incidence and severity of adverse events

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

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

Secondary outcomes

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

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

    Detect CAR-T copies number by qPCR

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

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

    Detect CAR-T copies number by qPCR

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

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

    Detect CAR-T copies number by qPCR

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

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

    Detect CAR-T copies number by qPCR

  5. Overall response rate (ORR)

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

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

  6. Duration of response (DOR)

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

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

  7. Progression-free survival (PFS)

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

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

  8. Overall survival (OS)

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

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

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Collaborators

  • Shanghai AbelZeta Ltd.

Registry information

Official study title

A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed and/or Refractory NHL

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Dec 7, 2020
Registry last updated
May 23, 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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