Non-Hodgkin's B-cell LymphomaPhase 1NCT04696432
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 Non-Hodgkin's B-cell Lymphoma, run by Tianjin Medical University Cancer Institute and 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
- 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
- 7 participants
- Where
- 1 siteChina
- Study dates
- 27 Nov 2020to 30 Dec 2023
- 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
- 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;
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- 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;
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
- Any situation that the investigator believes will harm the safety of the subjects 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 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 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
Tianjin Medical University Cancer Institute & Hosipital
Tianjin, Tianjin Municipality, 300060
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
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
- Conditions
- Non-Hodgkin's B-cell 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 (AE)
Incidence and severity of adverse events, including AE, Serious AE, AE of special interset (AESI)
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
The last of C-CAR039 in the peripheral blood after infusion (Tlast)
Detect CAR-T copies number by qPCR
Measured: Up to 24 Months after C-CAR039 infusion
AUC0-28d 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
Time to reach the maximum plasma concentration (Tmax)
Detect CAR-T copies number by qPCR
Measured: Up to 24 Months 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 posted6 Jan 2021
- Study start27 Nov 2020
- Primary completion31 Jul 2023
- Study completion30 Dec 2023
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 Non-Hodgkin's B-cell LymphomaStudies of the same condition, open and under way.
- More trials run by Tianjin Medical University Cancer Institute and 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
- 7 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
- Investigators
- Lanfang Li, PhD&MD, Principal investigator, Tianjin Medical University Cancer Institute & Hosipital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04696432
- Sponsor's protocol ID
- 0702-021
- Status last verified
- Dec 2023
- First submitted
- 30 Nov 2020
- Last updated
- 28 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 28 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
- NCT04696432
- Acronym / sponsor ID
- 0702-021
- Conditions
- Non-Hodgkin's B-cell Lymphoma
- Keywords
- CD19/CD20-directed CAR-T cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Tianjin Medical University Cancer Institute and HospitalUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 6 Jan 2021 (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
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
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 (10 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
- Any situation that the investigator believes will harm the safety of the subjects 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 (AE)
Time frame: Up to 24 months after C-CAR039 infusion
Incidence and severity of adverse events, including AE, Serious AE, AE of special interset (AESI)
8 secondary outcomes
Maximum concentration of C-CAR039 in the peripheral blood (Cmax)
Time frame: Up to 24 Months after C-CAR039 infusion
The last of C-CAR039 in the peripheral blood after infusion (Tlast)
Time frame: Up to 24 Months after C-CAR039 infusion
AUC0-28d of C-CAR039 in the peripheral blood (AUC0-28d)
Time frame: Up to 28 days after C-CAR039 infusion
Time to reach the maximum plasma concentration (Tmax)
Time frame: Up to 24 Months 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 28 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.
Lanfang Li, PhD&MD principal investigator
Tianjin Medical University Cancer Institute & Hosipital
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 Non-Hodgkin's B-cell Lymphoma, run by Tianjin Medical University Cancer Institute and 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 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: finished, as of the sponsor's last update on 28 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 (AE) (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 NCT04696432, 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 May 2025.