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Non-Hodgkin's B-cell LymphomaPhase 1NCT04693676

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

A Phase 1 study testing Prizloncabtagene Autoleucel in people with Non-Hodgkin's B-cell Lymphoma, run by First Affiliated Hospital of Zhejiang University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Non-Hodgkin's B-cell Lymphoma
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
17 participants
Where
1 siteChina
Study dates
3 Aug 2020to 30 Apr 2024
Phase
Phase 1
Are there results?
None posted in the registry

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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • The patient volunteered to participate in the study and signed the Informed Consent;
  • Age between 18 and 70 (including 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)
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  • 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 function.

Who cannot join

  • 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;
  • 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 uncontrolled, active disease that prevents participation in the trial;
  • 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 their cell transfusion;
  • Active or uncontrolled infections requiring systemic treatment within 14 days before enrollment;
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  • Patients who have been previously 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 was performed within 2 weeks before conditional treatment chemotherapy pretreatment;
  • Any situation that the investigator believes would compromise the safety of the subject or interfere with the purpose of the study;
  • 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 deemed unsuitable for enrollment by the investigator.

Trial locations and contacts

1 site in 1 country.

China1 site

  • The First Affiliated Hospital, College of Medicine, Zhejiang University

    Hangzhou, Zhejiang, 310003

Other trials in China

About this study

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

This is a single-arm, open label, dose escalation, phase I study of C-CAR039 in adults with relapsed/refractory B-cell Non-Hodgkin's Lymphoma.

Read the detailed description

This is a single-arm, open label, "3+3" dose escalation, 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.

Being tested
Prizloncabtagene Autoleucel
Medical subject headings
Lymphoma, B-Cell

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

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

Study groups in NCT04693676
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. MTD

    maximum tolerated dose or clinical recommended dose

    Measured: Up to 24 months after C-CAR039 infusion

  2. DLT

    Dose limiting toxicity

    Measured: Up to 28 days after C-CAR039 infusion

  3. AE/SAE/AESI

    adverse events (AE), serious adverse event (SAE), adverse events of sepical interest (AESI) (including cytokine release syndrome (CRS), and nerve toxicity), laboratory tests (type, frequency and severity), vital signs and ECG abnormality rate.

    Measured: Up to 24 months after C-CAR039 infusion

Secondary outcomes (5)

  1. C-CAR039 CAR expansion and persistence

    After C-CAR039 infusion, peripheral blood EXP039 CAR expansion and persistence in vivo, including Cmax, Tmax, AUC0-28day, Tlast

    Measured: Up to 24 Months after C-CAR039 infusion

  2. Overall response rate (ORR)

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

    Measured: Up to 24 Months after C-CAR039 infusion

  3. 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

    Measured: Up to 24 Months after C-CAR039 infusion

  4. Progression-free survival (PFS)

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

    Measured: Up to 24 Months after C-CAR039 infusion

  5. Overall survival (OS)

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

    Measured: Up to 24 Months 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 posted5 Jan 2021
  2. Study start3 Aug 2020
  3. Primary completion31 Dec 2023 (estimated)
  4. Study completion30 Apr 2024 (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
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04693676
Sponsor's protocol ID
0702-025
Status last verified
May 2023
First submitted
3 Dec 2020
Last updated
28 Sep 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Yu W, Li P, Zhou L, Yang M, Ye S, Zhu D, Huang J, Yao X, Zhang Y, Li L, Zhao J, Zhu K, Li J, Zheng C, Lan L, Wan H, Yao Y, Zhang H, Zhou D, Jin J, Liang A. A phase 1 trial of prizloncabtagene autoleucel, a CD19/CD20 CAR T-cell therapy for relapsed/refractory B-cell non-Hodgkin lymphoma. Blood. 2025 Apr 3;145(14):1526-1535. doi: 10.1182/blood.2024026401.

    PubMed 39813680

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Prizloncabtagene Autoleucel in people with Non-Hodgkin's B-cell Lymphoma, run by First Affiliated Hospital of Zhejiang University at 1 site 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 10 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 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.

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

Are results available for this study?

Results are not available in the source record.

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

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD (time frame: Up to 24 months 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 NCT04693676, which also lists 1 linked publication.

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 28 Sep 2023.

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