B-cell Non-Hodgkin's LymphomaPhase 1NCT04655677
A Study of C-CAR039 Treatment in Subjects With r/r NHL SubjectsNon-Hodgkin's Lymphoma
A Phase 1 study testing Prizloncabtagene Autoleucel in people with B-cell Non-Hodgkin's Lymphoma, run by Peking Union Medical College Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Non-Hodgkin's 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
- 10 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2020to 30 Jun 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
None listed.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Peking Union Medical College Hospital
Beijing, Beijing/China, 100000
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-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.
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Being tested
- Prizloncabtagene Autoleucel
- Keywords
- CD19/CD20-directed CAR-T cells
- 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 group | Role | What they receive |
|---|---|---|
| Prizloncabtagene Autoleucel | Experimental | Prizlon-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.
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
Measured: Up to 24 months after C-CAR039 infusion
Secondary outcomes (8)
Maximum concentration of C-CAR039 in the peripheral blood (Cmax)
Detect CAR-T copies number by qPCR
Measured: Up to 24 Months after C-CAR039 infusion
Time to maximum concentration of C-CAR039 in the peripheral blood (Tmax)
Detect CAR-T copies number by qPCR
Measured: Up to 24 Months after C-CAR039 infusion
Tlast of C-CAR039 in the peripheral blood after infusio (Tlast)
Detect CAR-T copies number by qPCR
Measured: Up to 24 Months after C-CAR039 infusion
AUC0h-28d of C-CAR039 in the peripheral blood (AUC0-28d)
Detect CAR-T copies number by qPCR
Measured: Up to 28 days after C-CAR039 infusion
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
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
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
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.
- First posted7 Dec 2020
- Study start30 Oct 2020
- Primary completion28 Feb 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Principal investigator, Yan Zhang, MD, Peking Union Medical College Hospital
- Investigators
- Daobin Zhou, PhD&MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04655677
- Sponsor's protocol ID
- 0702-023
- Status last verified
- May 2025
- First submitted
- 25 Sep 2020
- Last updated
- 23 May 2025
- 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
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Subjects With Relapsed and/or Refractory NHL
- ClinicalTrials.gov ID
- NCT04655677
- Acronym / sponsor ID
- 0702-023
- Conditions
- B-cell Non-Hodgkin's Lymphoma
- Keywords
- CD19/CD20-directed CAR-T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 30 Oct 2020 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 7 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prizloncabtagene Autoleucel | Experimental | Biological: Prizloncabtagene AutoleucelPrizlon-cel will be intravenously administered as a single infusion after lymphodepletion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (13 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Prizloncabtagene AutoleucelAlso: C-CAR039Autologous 2nd generation CD19/CD20-directed CAR-T cells, single infusion intravenously | Biological | Prizloncabtagene Autoleucel |
Primary outcome
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
8 secondary outcomes
Maximum concentration of C-CAR039 in the peripheral blood (Cmax)
Time frame: Up to 24 Months after C-CAR039 infusion
Time to maximum concentration of C-CAR039 in the peripheral blood (Tmax)
Time frame: Up to 24 Months after C-CAR039 infusion
Tlast of C-CAR039 in the peripheral blood after infusio (Tlast)
Time frame: Up to 24 Months after C-CAR039 infusion
AUC0h-28d of C-CAR039 in the peripheral blood (AUC0-28d)
Time frame: Up to 28 days after C-CAR039 infusion
Overall response rate (ORR)
Time frame: Up to 24 Months after C-CAR039 infusion
Duration of response (DOR)
Time frame: Up to 24 Months after C-CAR039 infusion
Progression-free survival (PFS)
Time frame: Up to 24 Months after C-CAR039 infusion
Overall survival (OS)
Time frame: Up to 24 Months after C-CAR039 infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Derived from this study: PubMed 39813680Yu 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Daobin Zhou, PhD&MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Prizloncabtagene Autoleucel in people with B-cell Non-Hodgkin's Lymphoma, run by Peking Union Medical College Hospital 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 0 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: finished, as of the sponsor's last update on 23 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incidence and severity of adverse events (time frame: Up to 24 months after C-CAR039 infusion). 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 NCT04655677, 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 23 May 2025.