Non-Hodgkin's B-cell LymphomaPhase 1NCT04317885
A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in NHL Subjects
A Phase 1 study testing Prizloncabtagene Autoleucel in people with Non-Hodgkin's B-cell Lymphoma, run by Shanghai Tongji Hospital, Tongji University School of Medicine at 1 site in China.
Trial summary
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients Read more about this study
- Who is it for?
- Ages 18 to 75 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
- 25 participants
- Where
- 1 siteChina
- Study dates
- 5 Nov 2019to 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Volunteered to participate in this study and signed informed consent
- 2. Age 18-75 years old, male or female
- 3. CD19 or CD20 positive DLBCL (including PMBCL and tFL), FL and MCL confirmed by cytology or histology according to WHO2016 criteria. 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 should be recorded.
- 4. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
- 5. At least one measurable lesion (LDi ≥ 1.5 cm);
- 6. At least two weeks from last treatment (radiation, chemotherapy, mAb, etc) to apheresis;
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- 7. LVEF≥ 50% (ECHO)
- 8. No active pulmonary infections, normal or mild impaired pulmonary function and SpO2≥92%
- 9. Laboratory criteria: ANC≥1.0×109/L; Platelets≥50×109/L; Serum total bilirubin ≤1.5x ULN; Creatinine≤ ULN; AST and ALT≤3x ULN
- 10. No contraindications of apheresis;
- 11. Expected survival ≥ 3months
- 12. ECOG score 0 or 1
Who cannot join
- 1. Have a history of allergy to cellular products;
- 2. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
- 3. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
- 4. Patients with central nervous system involvement;
- 5. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
- 6. Received allogeneic hematopoietic stem cell transplantation before;
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- 7. Previous use of any CAR T cell product or other genetically modified T cell therapy;
- 8. Autologous stem cell transplantation within 6 weeks before infusion;
- 9. Severe active infections (except for simple urinary tract infections, bacterial pharyngitis), or currently undergoing intravenous infusion of antibiotics. However, prophylactic antibiotic, antiviral and antifungal infection treatments are permissible;
- 10. Live vaccination within 4 weeks prior to apheresis;
- 11. People infected with HIV, HBV, HCV and TPPA/RPR, and carriers with HBV;
- 12. A history of alcohol abuse, drug use or mental illness;
- 13. Subjects who are not sterilized and have any of the following conditions:
- are pregnant/lactating; or
- planned pregnancy during the trial; or
- being fertile and unable to use effective contraception;
- 14. Severe hypersensitivity to fludarabine or cyclophosphamide;
- 15. A history of other primary cancers other than the following:
- Non-melanoma tumors such as basal cell carcinoma of the skin that are cured by excision
- Cured in situ cancers such as cervical, bladder, or breast cancer
- 16. The investigators consider that the subject has other conditions that are not suitable for this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
Shanghai Tongji Hospital, Tongji University School of Medicine
Shanghai, Shanghai Municipality, 200065
About this study
Official title: A Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Relapsed or Refractory NHL Subjects
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
Read the detailed description
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection.
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, C-CAR039 infusion, and Follow-up Visit.
- Conditions
- Non-Hodgkin's B-cell Lymphoma
- 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 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 CAR-T infusion
Measured: Up to 12 weeks after C-CAR039 infusion
Secondary outcomes (4)
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 CR) 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 posted23 Mar 2020
- Study start5 Nov 2019
- Primary completion30 Jun 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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Principal investigator, Aibin Liang，MD，Ph.D., Shanghai Tongji Hospital, Tongji University School of Medicine
- Investigators
- Aibin Liang, MD, Ph.D, Principal investigator, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04317885
- Sponsor's protocol ID
- 0702-015
- Status last verified
- May 2025
- First submitted
- 20 Mar 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 Study Evaluating Safety and Efficacy of C-CAR039 Treatment in Relapsed or Refractory NHL Subjects
- ClinicalTrials.gov ID
- NCT04317885
- Acronym / sponsor ID
- 0702-015
- Conditions
- Non-Hodgkin's B-cell Lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Shanghai Tongji Hospital, Tongji University School of MedicineUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 5 Nov 2019 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 30 Dec 2023 (actual)
- First posted
- 23 Mar 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.
The trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of C-CAR039 in treatment of relapsed or refractory NHL patients
Detailed description
This study plans to enroll 25 patients to assess the safety and efficacy of C-CAR039. Subjects who meet the eligibility criteria will receive a single dose of C-CAR039 injection.
The study will include the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Bridging (if needed), Baseline, lymphodepletion, 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 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 1. Volunteered to participate in this study and signed informed consent
- 2. Age 18-75 years old, male or female
- 3. CD19 or CD20 positive DLBCL (including PMBCL and tFL), FL and MCL confirmed by cytology or histology according to WHO2016 criteria. 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 should be recorded.
- 4. Relapsed or refractory disease after ≥ 2 lines (for FL, at least 3 lines) of standard therapy or relapsed after autologous stem cell transplantation (ASCT)
- 5. At least one measurable lesion (LDi ≥ 1.5 cm);
Key exclusion criteria (21 listed)
- 1. Have a history of allergy to cellular products;
- 2. According to the NYHA cardiac function grading standards, patients with grade III or IV cardiac dysfunction;
- 3. A history of craniocerebral trauma, disturbance of consciousness, epilepsy, cerebrovascular ischemia, cerebrovascular hemorrhagic disease, etc.;
- 4. Patients with central nervous system involvement;
- 5. Patients with autoimmune diseases, immunodeficiency or other conditions requiring immunosuppressive therapy;
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 12 weeks after C-CAR039 infusion
Incidence and severity of adverse events after CAR-T infusion
4 secondary outcomes
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.
Aibin Liang, MD, Ph.D principal investigator
Shanghai Tongji Hospital, Tongji University School of Medicine
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 Shanghai Tongji Hospital, Tongji University School of Medicine 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 12 inclusion and 21 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 12 weeks 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 NCT04317885, 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.