B Cell Non-Hodgkin's LymphomaPhase 1NCT05149391
A Study of C-CAR039 in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma
A Phase 1 study testing CD19/CD20-directed Chimeric Antigen Receptor T Cells in people with B Cell Non-Hodgkin's Lymphoma, run by Peking University 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 cell Non-Hodgkin's Lymphoma 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?
- CD19/CD20-directed Chimeric Antigen Receptor T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2021to 30 May 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, 18-70 years (include 18 and 70), male or female;
- Expected survival ≥ 12 weeks
- Eastern Cooperative Oncology Group score 0-2
- CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
- Patients with a clear diagnosis of relapsed and/or refractory B-Non-Hodgkin's lymphoma, including Diffuse Large B Cell Lymphoma, Follicular Lymphoma and Mantle Cell Lymphoma. Diffuse Large B Cell Lymphoma includes the following types:
Show all 23Show fewer
- Diffuse Large B Cell Lymphoma, Non Specifically
- Primary Mediastinal B-cell Lymphoma
- Transformed Follicular Lymphoma
- High Grade B-Cell Lymphoma With MYC and BCL2 and/or BCL6
- High Grade B-Cell Lymphoma, Non Specifically
- 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 and adequate bone marrow reserve
- Hemoglobin≥80 g/L
- Absolute neutrophil count≥1.0×109/L
- Platelet≥50×109/L,
- Creatinine≤1.5×upper limit of the normal range (ULN)
- Cardiac ejection fraction≥50%
- Saturation of Pulse Oxygen>92%
- Total bilirubin≤1.5×ULN
- Alanine Aminotransferase/Aspartate Aminotransferase≤3×ULN
Who cannot join
- Malignant tumors other than B-Non-Hodgkin's lymphoma 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;
- Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus 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 treatment;
- 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;
- 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;
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-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 cell Non-Hodgkin's Lymphoma patients.
Read the detailed description
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation and Follow-up Visit.
- Conditions
- B Cell Non-Hodgkin's Lymphoma
- Being tested
- CD19/CD20-directed Chimeric Antigen Receptor T Cells
- Keywords
- CD19/CD20-directed Chimeric Antigen Receptor 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.
CD19/CD20-directed Chimeric Antigen Receptor T CellsBiological
Also called C-CAR039
Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously
| Study group | Role | What they receive |
|---|---|---|
| C-CAR039 | Experimental | Autologous C-CAR039 administered by intravenous (IV) infusion Receives: Biological: CD19/CD20-directed Chimeric Antigen Receptor T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety Observation
Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity
Measured: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
Secondary outcomes (8)
Maximum concentration (Cmax) of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by quantitative polymerase chain reaction(qPCR).
Measured: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Measured: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Measured: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Area under the curve 0h-28d of C-CAR039 in the peripheral blood.
Detect Chimeric Antigen Receptor-T copies number by qPCR.
Measured: Baseline, Days 4, 7, 10 and weeks 2, 3, 4
Overall response rate (ORR)
Complete response (CR) rate plus partial response (PR) rate by Lugano 2014 criteria.
Measured: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
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
Progression-free survival (PFS)
The time from C-CAR039 infusion to the date of progression as assessed by Lugano 2014 criteria or death.
Measured: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Overall survival (OS)
The time from C-CAR039 infusion to the date of death.
Measured: up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2021
- Study start20 Jul 2021
- Primary completion30 Jan 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B Cell Non-Hodgkin's LymphomaStudies of the same condition, open and under way.
- More trials run by Peking UniversityThe 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Responsible party
- Principal investigator, Jun Zhu, Peking University Cancer Hospital & Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05149391
- Sponsor's protocol ID
- 0702-022
- Status last verified
- Nov 2021
- First submitted
- 9 Nov 2021
- Last updated
- 30 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of CD19 and CD20 Targeted Chimeric Antigen Receptor T Cells Therapy (C-CAR039) in Subjects With Relapsed and/or Refractory B Cell Non-Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT05149391
- Acronym / sponsor ID
- 0702-022
- Conditions
- B Cell Non-Hodgkin's Lymphoma
- Keywords
- CD19/CD20-directed Chimeric Antigen Receptor T Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Peking University Cancer Hospital & Institute
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 8 Dec 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 cell Non-Hodgkin's Lymphoma patients.
Detailed description
The study includes the following sequential phases: Screening, Apheresis and C-CAR039 manufacturing, Baseline testing, Lymphodepletion, C-CAR039 infusion, Dose-limiting toxicity observation 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 |
|---|---|---|
| C-CAR039 | Experimental | Biological: CD19/CD20-directed Chimeric Antigen Receptor T CellsAutologous C-CAR039 administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- The patient volunteered to participate in the study and signed the Informed Consent;
- Age, 18-70 years (include 18 and 70), male or female;
- Expected survival ≥ 12 weeks
- Eastern Cooperative Oncology Group score 0-2
- CD19 or CD20 positive B-Non-Hodgkin's lymphoma confirmed by cytology or histology according to World Health Organization 2016 criteria;
Key exclusion criteria (8 listed)
- Malignant tumors other than B-Non-Hodgkin's lymphoma 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;
- Human Immunodeficiency Virus, Hepatitis B Virus, Hepatitis C Virus 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 treatment;
- 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;
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 |
|---|---|---|
| CD19/CD20-directed Chimeric Antigen Receptor T CellsAlso: C-CAR039Autologous 2nd generation CD19/CD20-directed Chimeric Antigen Receptor T Cells, single infusion intravenously | Biological | C-CAR039 |
Primary outcome
Safety Observation
Time frame: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.
Incidence of adverse events after C-CAR039 infusion. Incidence and severity of adverse events according to NCI-CTCAE v5.0 criteria, including Dose Limited Toxicity
8 secondary outcomes
Maximum concentration (Cmax) of C-CAR039 in the peripheral blood.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Time to maximum concentration (Tmax) of C-CAR039 in the peripheral blood.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Peripheral blood duration of C-CAR039 in the peripheral blood after infusion.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4, 8, 12 and month 6, 9, 12, 15, 18, 21, 24
Area under the curve 0h-28d of C-CAR039 in the peripheral blood.
Time frame: Baseline, Days 4, 7, 10 and weeks 2, 3, 4
Overall response rate (ORR)
Time frame: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Duration of response (DOR)
Time frame: up to 24 months
Progression-free survival (PFS)
Time frame: 4 weeks, 12 weeks, 6 months, 9 months, 12 months, 15 months, 18 months, 21 months, 24 months
Overall survival (OS)
Time frame: up to 24 months
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 30 Jan 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 CD19/CD20-directed Chimeric Antigen Receptor T Cells in people with B Cell Non-Hodgkin's Lymphoma, run by Peking 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 23 inclusion and 8 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 30 Jan 2026. 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?
Safety Observation (time frame: up to 24 Months. Incidence and severity of adverse events after C-CAR039 infusion according to National Cancer Institute Common Terminology Criteria for Adverse Events v5.0 criteria, including dose-limiting toxicity (DLT) and laboratory abnormalities.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Jan 2026.