B-Cell Non-Hodgkin LymphomaPhase 1NCT07024147
JWCAR239 in Patients With B Cell Non-Hodgkin Lymphoma
A Phase 1 study testing JWCAR239, Fludarabine and Cyclophosphamide in people with B-Cell Non-Hodgkin Lymphoma and Large B Cell Diffuse Lymphoma, run by Peking University Cancer Hospital & Institute at 1 site in China.
Trial summary
JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non-Hodgkin Lymphoma, Large B Cell Diffuse Lymphoma, Follicular Lymphoma
- What is being tested?
- JWCAR239, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2025to 1 Jul 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed B-NHL with immunohistochemical positivity for CD20 and/or CD19 (accepting previous pathological reports and/or pathological review results of previous or fresh tumor tissues). According to the 2022 World Health Organization (WHO) classification, the pathological types include:Diffuse large B-cell lymphoma, Follicular large B-cell lymphoma (FL3B),Large B-cell lymphoma transformed from indolent B-NHL, Follicular lymphoma (excluding in situ follicular lymphoma, pediatric-type follicular lymphoma, and duodenal-type follicular lymphoma),Marginal zone lymphoma Mantle cell lymphoma (excluding in situ mantle cell neoplasms and leukemic non-nodal mantle cell lymphoma)
- Relapsed or refractory disease after receiving two or more lines of adequate treatment, or failure after autologous hematopoietic stem cell transplantation (ASCT).
- CT-measurable lesions and PET-evaluable positive lesions as defined by the 2014 Lugano criteria (lymph node or extranodal lesions must have two measurable diameters; lymph node lesions must have a long diameter >1.5 cm, and extranodal lesions must have a long diameter >1 cm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function:
- Sufficient bone marrow function as assessed by the investigator (absolute neutrophil count ≥1,000/μL after at least 72 hours off growth factors; platelet count ≥50,000/μL without blood transfusion within 7 days; absolute lymphocyte count ≥100/μL).
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- Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥50 mL/min (calculated by the Cockcroft-Gault formula).
- Alanine aminotransferase (ALT) ≤5×ULN and total bilirubin <2×ULN (or <3×ULN for subjects with Gilbert syndrome or hepatic involvement by lymphoma).
- Pulmonary function: ≤ CTCAE Grade 1 dyspnea and SpO2 ≥92% in room air. Cardiac function: Left ventricular ejection fraction (LVEF) ≥50% as assessed by echocardiography.
- Adequate vascular access for leukapheresis.
- Expected survival >12 weeks.
- Non-abstinent female subjects of childbearing potential must agree to use a highly effective contraceptive method plus an additional barrier method from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion. Male subjects with fertile partners must agree to use effective contraception from at least 28 days before lymphodepletion until 2 years after JWCAR239 infusion and must not donate semen or sperm throughout the study.
Who cannot join
- Lymphoma involving the central nervous system (CNS).
- EBV-positive DLBCL or Richter transformation of chronic lymphocytic leukemia.
- History of other malignant tumors with complete remission for less than 2 years, or current presence of other malignant tumors (exceptions to the 2-year restriction include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, treated localized prostate cancer, biopsy-confirmed cervical in situ carcinoma, or cervical smears showing squamous intraepithelial lesions, or completely resected tumors with low recurrence potential as assessed by the investigator).
- At screening, the subject has:
- Active hepatitis B or C (subjects with HBV DNA or HCV RNA below the lower limit of the central reference value by PCR may be enrolled). For occult or prior HBV-infected subjects, prophylactic antiviral therapy and regular monitoring of HBV-DNA are required.
- Human immunodeficiency virus (HIV) infection or syphilis infection.
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- Acute deep vein thrombosis (DVT) (tumor thrombus or thrombus) or pulmonary embolism (PE) within 3 months prior to informed consent signing.
- Receiving anticoagulant therapy for acute DVT or PE within 3 months prior to informed consent signing (prophylactic treatment ).
- Uncontrolled systemic fungal, bacterial, viral, or other infections.
- Acute or chronic graft-versus-host disease (GvHD).
- History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, coronary angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.
- Clinically significant CNS disease or symptoms at screening or within the past 6 months, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.
- Pregnant or lactating women. Females of childbearing potential must have a negative serum pregnancy test within 48 hours before starting lymphodepletion chemotherapy.
- Use of any of the following drugs or treatments within the specified time before leukapheresis:
- Alemtuzumab within 6 months before leukapheresis. Bendamustine within 6 months before leukapheresis. Cladribine within 3 months before leukapheresis. Fludarabine within 3 months before leukapheresis. Anti-CD20 monoclonal antibodies within 7 days before leukapheresis. Venetoclax within 4 days before leukapheresis. Idelalisib within 2 days before leukapheresis. Lenalidomide within 1 day before leukapheresis. Pharmacological doses of corticosteroids (defined as prednisone >5 mg/day or equivalent) within 7 days before leukapheresis or within 72 hours before JWCAR239 injection. Physiological replacement, topical, and inhaled steroids are permitted.
- Chemotherapy (e.g., vincristine, rituximab, cyclophosphamide) required to control the disease after leukapheresis must have been discontinued ≥7 days before lymphodepletion chemotherapy.
- Administration of non-lymphocyte-toxic cytotoxic chemotherapy within 1 week before leukapheresis. Enrollment is permitted if the oral chemotherapy has undergone at least 3 half-lives before leukapheresis.
- Receipt of lymphocyte-toxic chemotherapy (e.g., cyclophosphamide, ifosfamide, chlorambucil, or melphalan) within 2 weeks before leukapheresis.
- Use of investigational drugs within 4 weeks before leukapheresis. However, enrollment is permitted if the investigational treatment was ineffective or caused disease progression, and at least 3 half-lives have elapsed before leukapheresis.
- Treatment with immunosuppressive agents (e.g., calcineurin inhibitors, methotrexate or other chemotherapeutic drugs, mycophenolate, rapamycin, thalidomide, immunosuppressive antibodies such as anti-TNF, anti-IL-6, or anti-IL-6R) within 4 weeks before leukapheresis and JWCAR239 injection.
- Receipt of donor lymphocyte infusion (DLI) within 6 weeks before JWCAR239 injection.
- Radiation therapy involving large bone marrow areas (e.g., sternum or pelvis) within 6 weeks before leukapheresis. Subjects are eligible only if the disease progresses at the radiation site or PET-positive lesions exist in non-irradiated areas. If PET-positive lesions exist in non-irradiated areas, radiation therapy to a single lesion is permitted within 2 weeks before leukapheresis.
- Any other significant disease, abnormality, or condition that, in the investigator's judgment, renders the subject unsuitable for participation in the study or places the subject at risk. Any factors affecting compliance with the protocol, including uncontrollable medical, psychological, family, sociological, or geographical factors; or unwillingness or inability to adhere to the procedures required by the study protocol.
- Prior allogeneic hematopoietic stem cell transplantation.
- Prior treatment with CAR+ T cells or other genetically modified T cells.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Beijing cancer hospital
Beijing, Beijing Municipality, 100010
Yuqin Song, PhD, +86 010-88121122, songyuqin622@163.com
About this study
Official title: An Open-Label, Single-arm Study of JWCAR239 in the Treatment of Relapse / Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)
JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)
Read the detailed description
JWCAR239 is a CD19/CD20 CAR-T product. By targeting both CD19 and CD20, it is expected to overcome some limitations with CD19 or CD20 single target products. In this study, patients with B B-NHL will be enrolled to receive JWCAR239. PK/PD properties and preliminary efficacy and safety will be evaluated. Each subject will receive JWCAR239 once and is followed up for up to 2 years.
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Large B Cell Diffuse Lymphoma, Follicular Lymphoma, Marginal Zone B Cell Lymphoma, Mantle Cell Lymphoma (MCL)
- Being tested
- JWCAR239, Fludarabine, Cyclophosphamide
- Keywords
- CAR-T, dual target, B-NHL
- Medical subject headings
- Lymphoma, B-Cell, Lymphoma, Large B-Cell, Diffuse, Lymphoma, Follicular, Lymphoma, B-Cell, Marginal Zone, Lymphoma, Mantle-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JWCAR239Biological
A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells targeting CD19/CD20
FludarabineDrug
Administered according to package insert
CyclophosphamideDrug
Administered according to package insert
| Study group | Role | What they receive |
|---|---|---|
| JWCAR239 arm | Experimental | Participants will receive cyclophosphamide 250-300mg/m^2/day intravenously (IV) and fludarabine 25-30mg/m^2/day IV conditioning chemotherapy for 3 days followed by JWCAR239 administered as a single IV infusion at a target dose of 2 .5-30x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day 1. Receives: Biological: JWCAR239; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of Dose Limiting Toxicity events
Dose-Limiting Toxicity (DLT) refers to a specific type of adverse effect or toxic reaction caused by a drug or treatment that is severe enough to prevent an increase in dose or continuation of treatment.
Measured: 28 days
AE and SAE rate
ny adverse event (AE) or serious adverse event (SAE) occurring after JWCAR239 administration
Measured: up to 2 years
Secondary outcomes (9)
Pharmacokinetic (PK)- Cmax of JWCAR239
Maximum observed concentration of JWCAR239 in peripheral blood
Measured: from baseline up to 2 years
PD
Peripheral blood levels of CD19+ and/or CD20+ B cells
Measured: from baseline up to 2 years
overall response rate (ORR)
ORR is the proportion of subjects who achieve positive response to the treatment. It includes complete response and partial response.
Measured: from baseline up to 2 years
complete response rate (CRR)
CRR refers to the proportion of subjects whose cancer signs disappear
Measured: from baseline up to 2 years
duration of response(DOR)
in subjects with hematology malignancy The duration of a subject staying in response state
Measured: from baseline up to 2 years
progression free survival(PFS)
the length of time during and after treatment that a subject lives with the disease without the disease worsening or progressing
Measured: from baseline up to 2 years
Overall survival(OS)
the length of time from the start of treatment that patients are still alive
Measured: from baseline up to 2 years
Pharmacokinetic (PK)- Tmax of JWCAR239
Time to maximum concentration of JWCAR239 in the peripheral blood
Measured: up to 2 year after JWCAR239 infusion
Pharmacokinetic (PK)- AUC of JWCAR239
Area under the concentration vs time curve of JWCAR239
Measured: up to 2 year after JWCAR239 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2025
- Study start1 Jul 2025 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2030 (estimated)
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 LymphomaStudies of the same condition, open and under way.
- More trials run by Peking University Cancer Hospital & InstituteThe 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
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Cancer Hospital & Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai JW Therapeutics Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07024147
- Sponsor's protocol ID
- JWCAR239001
- Status last verified
- May 2025
- First submitted
- 27 May 2025
- Last updated
- 17 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 17 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-arm Study of JWCAR239 in the Treatment of Relapse / Refractory (R/R) B Cell Non-Hodgkin Lymphoma (B-NHL)
- ClinicalTrials.gov ID
- NCT07024147
- Acronym / sponsor ID
- JWCAR239001
- Conditions
- B-Cell Non-Hodgkin Lymphoma, Large B Cell Diffuse Lymphoma, Follicular Lymphoma, Marginal Zone B Cell Lymphoma, Mantle Cell Lymphoma (MCL)
- Keywords
- CAR-T, dual target, B-NHL
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Peking University Cancer Hospital & InstituteUniversity, hospital or other
- Collaborators
- Shanghai JW Therapeutics Co., Ltd.
- Study start
- 1 Jul 2025 (estimated)
- Primary completion
- 1 Jul 2027 (estimated)
- Study completion
- 1 Jul 2030 (estimated)
- First posted
- 17 Jun 2025 (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.
JWCAR239 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR239 in patients with B Cell Non-Hodgkin Lymphoma (B-NHL)
Detailed description
JWCAR239 is a CD19/CD20 CAR-T product. By targeting both CD19 and CD20, it is expected to overcome some limitations with CD19 or CD20 single target products. In this study, patients with B B-NHL will be enrolled to receive JWCAR239. PK/PD properties and preliminary efficacy and safety will be evaluated. Each subject will receive JWCAR239 once and is followed up for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JWCAR239 arm | Experimental | Biological: JWCAR239, Drug: Fludarabine, Drug: CyclophosphamideParticipants will receive cyclophosphamide 250-300mg/m^2/day intravenously (IV) and fludarabine 25-30mg/m^2/day IV conditioning chemotherapy for 3 days followed by JWCAR239 administered as a single IV infusion at a target dose of 2 .5-30x 10^6 anti-cluster of differentiation (CD)19 chimeric antigen receptor (CAR) transduced autologous T cells on Day 1. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Histologically confirmed B-NHL with immunohistochemical positivity for CD20 and/or CD19 (accepting previous pathological reports and/or pathological review results of previous or fresh tumor tissues). According to the 2022 World Health Organization (WHO) classification, the pathological types include:Diffuse large B-cell lymphoma, Follicular large B-cell lymphoma (FL3B),Large B-cell lymphoma transformed from indolent B-NHL, Follicular lymphoma (excluding in situ follicular lymphoma, pediatric-type follicular lymphoma, and duodenal-type follicular lymphoma),Marginal zone lymphoma Mantle cell lymphoma (excluding in situ mantle cell neoplasms and leukemic non-nodal mantle cell lymphoma)
- Relapsed or refractory disease after receiving two or more lines of adequate treatment, or failure after autologous hematopoietic stem cell transplantation (ASCT).
- CT-measurable lesions and PET-evaluable positive lesions as defined by the 2014 Lugano criteria (lymph node or extranodal lesions must have two measurable diameters; lymph node lesions must have a long diameter >1.5 cm, and extranodal lesions must have a long diameter >1 cm).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- Adequate organ function:
Key exclusion criteria (25 listed)
- Lymphoma involving the central nervous system (CNS).
- EBV-positive DLBCL or Richter transformation of chronic lymphocytic leukemia.
- History of other malignant tumors with complete remission for less than 2 years, or current presence of other malignant tumors (exceptions to the 2-year restriction include: basal cell carcinoma of the skin, squamous cell carcinoma of the skin, treated localized prostate cancer, biopsy-confirmed cervical in situ carcinoma, or cervical smears showing squamous intraepithelial lesions, or completely resected tumors with low recurrence potential as assessed by the investigator).
- At screening, the subject has:
- Active hepatitis B or C (subjects with HBV DNA or HCV RNA below the lower limit of the central reference value by PCR may be enrolled). For occult or prior HBV-infected subjects, prophylactic antiviral therapy and regular monitoring of HBV-DNA are required.
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 |
|---|---|---|
| JWCAR239A single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells targeting CD19/CD20 | Biological | JWCAR239 arm |
| FludarabineAdministered according to package insert | Drug | JWCAR239 arm |
| CyclophosphamideAdministered according to package insert | Drug | JWCAR239 arm |
Primary outcome
The rate of Dose Limiting Toxicity events
Time frame: 28 days
Dose-Limiting Toxicity (DLT) refers to a specific type of adverse effect or toxic reaction caused by a drug or treatment that is severe enough to prevent an increase in dose or continuation of treatment.
AE and SAE rate
Time frame: up to 2 years
ny adverse event (AE) or serious adverse event (SAE) occurring after JWCAR239 administration
9 secondary outcomes
Pharmacokinetic (PK)- Cmax of JWCAR239
Time frame: from baseline up to 2 years
PD
Time frame: from baseline up to 2 years
overall response rate (ORR)
Time frame: from baseline up to 2 years
complete response rate (CRR)
Time frame: from baseline up to 2 years
duration of response(DOR)
Time frame: from baseline up to 2 years
progression free survival(PFS)
Time frame: from baseline up to 2 years
Overall survival(OS)
Time frame: from baseline up to 2 years
Pharmacokinetic (PK)- Tmax of JWCAR239
Time frame: up to 2 year after JWCAR239 infusion
Pharmacokinetic (PK)- AUC of JWCAR239
Time frame: up to 2 year after JWCAR239 infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2025.
- 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.
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 JWCAR239, Fludarabine and Cyclophosphamide in people with B-Cell Non-Hodgkin Lymphoma and Large B Cell Diffuse Lymphoma, run by Peking University Cancer Hospital & Institute 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 25 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: opening soon, as of the sponsor's last update on 17 Jun 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuqin Song, PhD (+86 010-88121122, songyuqin622@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of Dose Limiting Toxicity events (time frame: 28 days). The study lists 2 primary outcomes in all. 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 17 Jun 2025.