B-cell TumorsPhase 1NCT06567080
JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases
A Phase 1 study testing JWCAR201 in people with B-cell Tumors and Autoimmune Diseases, run by RenJi Hospital at 1 site in China.
Trial summary
JWCAR201 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR201 in patients with B cell driven hematology malignancy and autoimmune diseases Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- B-cell Tumors, Autoimmune Diseases, Lupus Erythematosus, Systemic
- What is being tested?
- JWCAR201
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- Sep 2024to Mar 2027
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
- aged >= 18 years
- willing to sign ICF
- with histologically confirmed large B cell lymphoma and immunohistochemically positive CD20
- The subject must have previously been treated with an anthracycline and rituximab (or another CD20-targeted therapy), and must have relapsed, not achieved remission, or experienced disease progression after receiving at least two lines of therapy, including autologous hematopoietic stem cell transplantation (autoHSCT)
- The subject must have CT measurable lesions and PET evaluable lesions as determined by the Lugano criteria.
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- The subject must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
- For subjects with SLE:
- Voluntarily sign the informed consent form (ICF).
- At the time of signing the ICF, be between 18 and 70 years old (inclusive of 18 and 70 years), with no restriction on gender.
- Have been diagnosed with SLE (Systemic Lupus Erythematosus) for ≥ 6 months before screening, according to the 2019 EULAR/ACR revised criteria
- Have previously required treatment with corticosteroids combined with immunosuppressants and biologics, with the treatment regimen stable for >2 months and the dose stable for >2 weeks before screening, yet the disease remains active.
- At the time of screening, positive for antinuclear antibodies (ANA), and/or anti-dsDNA antibodies, and/or anti-Smith antibodies.
- SLEDAI-2K score ≥ 7 points during the screening period.
Who cannot join
- For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
- 1. Primary central nervous system (CNS) lymphoma (subjects with secondary CNS lymphoma are allowed to enroll).
- 2. A history of another malignancy that has not been in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with a low likelihood of recurrence, treated localized prostate cancer, biopsy-confirmed in situ cervical cancer, or squamous intraepithelial lesions identified on a PAP smear).
- 3. At the time of screening, the subject has:
- Hepatitis B surface antigen (HBsAg) positivity (regardless of whether or not there is an increase in hepatitis B virus DNA copies).
- Hepatitis B core antibody (HBcAb) positivity with an increase in hepatitis B virus DNA copies.
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- Hepatitis C, HIV, or syphilis infection. 4. The subject has had active deep vein thrombosis (DVT) (tumor thrombus or blood clot) or pulmonary embolism (PE) within 3 months prior to signing the informed consent form.
- 5. The subject has been undergoing anticoagulant therapy for active DVT or PE within 3 months prior to signing the informed consent form (prophylactic treatment is excluded).
- 6. Uncontrolled systemic fungal, bacterial, viral, or other infections. 7. Acute or chronic graft-versus-host disease (GvHD). 8. History of any of the following cardiovascular diseases within the past 6 months: New York Heart Association (NYHA) Class III or IV heart failure, cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant heart diseases.
- 9. Clinically significant CNS diseases within the past 6 months or at the time of screening, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychiatric disorders.
- 10. Pregnant or breastfeeding women. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to the start of lymphodepleting chemotherapy.
- 11. The investigator determines that the subject has any factors that could affect compliance with the protocol, including uncontrolled medical, psychological, familial, sociological, or geographical conditions; or the subject is unwilling or unable to comply with the procedures required by the study protocol.
- 12. The subject has previously received CAR-T cell therapy or other gene-modified T cell therapy.
- For subjects with SLE:
- Severe lupus nephritis requiring hemodialysis within 2 months before screening, or treatment with prednisone ≥ 100 mg/day or equivalent corticosteroids for ≥ 14 days.
- Lupus crisis within 1 month before screening, deemed unsuitable for participation in this study by the investigator.
- Clinically significant central nervous system disease or pathological changes not caused by lupus before screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, seizures/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis. Central nervous system manifestations caused by lupus before screening, including but not limited to lupus headache, seizures, cognitive impairment, intellectual disability, visual impairment, etc.
- Concurrent other autoimmune diseases requiring systemic treatment.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- At the time of screening:
- 1)Active hepatitis B. 2)Hepatitis C, HIV, or syphilis infection. 7. History of any of the following cardiovascular diseases within 6 months before screening: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmias, any ventricular arrhythmias, or other clinically significant heart diseases.
- 8. Use of any other investigational drug for SLE within 1 month before screening. However, if the investigational treatment was ineffective or the disease relapsed during the study treatment period, and at least 3 half-lives of the drug have passed before screening, the patient may be eligible for enrollment.
- 9. Previous treatment with CAR-T cells or other gene-modified T cell therapies. 10. History of ≥ Grade 2 bleeding within 30 days before screening, or the need for long-term continuous use of anticoagulant medications (such as warfarin, low molecular weight heparin, or factor Xa inhibitors).
- 11. Undergoing plasmapheresis, plasma exchange, or hemodialysis within 14 days before screening.
- 12. Use of any live vaccines for infectious diseases within 1 month before screening.
- 13. Known life-threatening allergic reaction, hypersensitivity, or intolerance to JWCAR201 cell product or its excipients (including dimethyl sulfoxide (DMSO)).
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
Renji Hospital, Shanghai Jiaotong University School of Medicine
Shanghai, 200001
About this study
Official title: An Open Label, Single Arm Study to Evaluate JWCAR201 Treating B Cell Driven Hematology Malignancy and Autoimmune Diseases
JWCAR201 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR201 in patients with B cell driven hematology malignancy and autoimmune diseases
Read the detailed description
JWCAR201 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 cell driven hematology malignancy and autoimmune diseases will be enrolled to receive JWCAR201. PK/PD properties and preliminary efficacy and safety will be evaluated. Each subject will receive JWCAR201 once and is followed up for up to 2 years.
- Being tested
- JWCAR201
- Medical subject headings
- Autoimmune Diseases, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JWCAR201Biological
JWCAR201 is a autologous CAR-T targeting CD19/CD20
| Study group | Role | What they receive |
|---|---|---|
| JWCAR201 arm | Experimental | Subjects in this arm will receive intervention with JWCAR201 Receives: Biological: JWCAR201 |
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
the rate of AE and SAE
any adverse event (AE) or serious adverse event (SAE) occurring after JWCAR201 administration
Measured: up to 2 years
Secondary outcomes (18)
the change of number of JWCAR201 cells by measuring the cell number and the number of transgene copies over time
to evaluate PK properties of JWCAR201, that is, how the human body processes the infused JWCAR201 cells
Measured: from baseline up to 2 years
the change of numbers of B cell subtypes (e.g., CD19+, CD20+ B cells) in the blood
these are parameters to evaluate PD properties of JWCAR201
Measured: from baseline up to 2 years
overall response rate (ORR) in subjects with hematology malignancy
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) in subjects with hematology malignancy
CRR refers to the proportion of subjects whose cancer signs disappear
Measured: from baseline up to 2 years
duration of response in subjects with hematology malignancy
The duration of a subject staying in response state
Measured: from baseline up to 2 years
progression free survival in subjects with hematology malignancy
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 in subjects with hematology malignancy
the length of time from the start of treatment that patients are still alive
Measured: from baseline up to 2 years
the proportion of subjects achieving LLDAS in subjects with SLE
Lupus Low Disease Activity State (LLDAS) is a target for treatment, representing a state where the disease is under control to a degree that is considered acceptable for the patient's long-term health and well-being. It includes below requirements: (1) SLE Disease Activity Index (SLEDAI)-2K ≤4, with no activity in major organ systems (renal, central nervous system (CNS), cardiopulmonary, vasculitis, fever) and no haemolytic anaemia or gastrointestinal activity; (2) no new lupus disease activity compared with the previous assessment; (3) a Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA)-SLEDAI physician global assessment (scale 0-3) ≤1; (4) a current prednisolone (or equivalent) dose ≤7.5 mg daily; and (5) well tolerated standard maintenance doses of immunosuppressive drugs and approved biological agents.
Measured: from baseline up to 2 years
the proportion of subjects achieving DORIS in subjects with SLE
Definitions of Remission in SLE (DORIS) is considered an optimal treatment goal, indicating that the disease is inactive and that the patient has minimal or no symptoms. DORIS includes below requirements: clinical systemic lupus erythematosus disease activity index (SLEDAI)-2K=0, Evaluator's Global Assessment <0.5 (0-3), prednisolone 5 mg/day or less, and stable antimalarials, immunosuppressives, and biologics.
Measured: from baseline up to 2 years
the proportion of subjects achieving SRI-4 in subjects with SLE
Systemic Lupus Erythematosus Responder Index-4 (SRI-4) is a composite index used in clinical trials to assess the effectiveness of treatments for SLE. To be considered a responder according to SRI-4, a patient must meet the following criteria:
- Reduction in SLEDAI-2K Score by ≥ 4 Points:
- No New BILAG A Scores, and No More Than 1 New BILAG B Score:
- No Worsening in Physician's Global Assessment (PGA):
Measured: from baseline up to 2 years
the change of BILAG-2004 score in subjects with SLE
British Isles Lupus Assessment Group (BILAG)-2004 is a score designed to evaluate lupus disease activity across nine organ system. For each organ system, disease activity is assessed and categorized into one of five levels:
A (Severe Activity): High disease activity requiring significant treatment, such as starting or increasing high-dose immunosuppressive therapy or biologics.
B (Moderate Activity): Moderate disease activity that might require an increase in treatment, such as adding or increasing corticosteroids or other immunosuppressive drugs.
C (Mild Activity): Mild disease activity that might not require a change in current treatment.
D (No Current Activity but Presence of Past Disease): The patient has no current disease activity, but there is evidence of past disease involvement in that organ system.
E (No Current or Past Activity): The patient has no current or past disease activity in that organ system.
Measured: from baseline up to 2 years
the change of Physician's global assessment (PGA) score in subjects with SLE
PGA is a subjective measure where the physician evaluates and rates the patient's disease activity based on their clinical judgment, considering all aspects of the disease, ranging from 0 to 3. The higher the score, the more severe the disease activity.
Measured: from baseline up to 2 years
the change of SLE-DAS score in subjects with SLE
Systemic Lupus Erythematosus-Disease Activity Score (SLE-DAS) is a validated, continuous measure of disease activity in patients with Systemic Lupus Erythematosus, typically ranging from 0 to over 20. The higher the score, the more active the disease.
Measured: from baseline up to 2 years
the proportion of subjects without other SLE therapies
If JWCAR201 works well, subjects would not need other SLE therapies
Measured: from baseline up to 2 years
The change of fatigue score in subjects with SLE
Fatigue is one of the common symptoms of SLE subjects. A numerical rating scale ranging from 0-10 will be used to assess fatigue, the higher the score, the more severe the fatigue.
Measured: from baseline up to 2 years
The change from baseline in immunoglobulins (IgA, IgE, IgG, IgM)
JWCAR201 can deplete B cells, thus decrease the concentration of immunoglobulins, which are produced by B cells.
Measured: from baseline up to 2 years
the change from baseline in complements (C3, C4)
Complement levels, C3 and C4, increase in active SLE and will decrease following effective treatment
Measured: from baseline up to 2 years
The change from baseline in auto-antibodies (anti-dsDNA antibody, ANA)
anti-dsDNA and ANA antibodies are auto-reactive antibodies produced by pathogenic B cells. JWCAR201 can deplete pathogenic B cells and decrease concentration of the auto-antibodies, indicating the improvement of SLE.
Measured: from baseline up to 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study startSep 2024 (estimated)
- Primary completionSep 2025 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for B-cell TumorsStudies of the same condition, open and under way.
- More trials run by RenJi 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Responsible party
- Principal investigator, Liangjing Lu, RenJi Hospital
- Investigators
- Liangjing Lu, Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567080
- Sponsor's protocol ID
- JWCAR201001
- Status last verified
- Aug 2024
- First submitted
- 15 Aug 2024
- Last updated
- 22 Aug 2024
- 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 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Single Arm Study to Evaluate JWCAR201 Treating B Cell Driven Hematology Malignancy and Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06567080
- Acronym / sponsor ID
- JWCAR201001
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Collaborators
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Study start
- Sep 2024 (estimated)
- Primary completion
- Sep 2025 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Aug 2024 (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.
JWCAR201 is a CD19/CD20 CAR-T product. This trial is intended to evaluate the safety, PK/PD and efficacy of JWCAR201 in patients with B cell driven hematology malignancy and autoimmune diseases
Detailed description
JWCAR201 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 cell driven hematology malignancy and autoimmune diseases will be enrolled to receive JWCAR201. PK/PD properties and preliminary efficacy and safety will be evaluated. Each subject will receive JWCAR201 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 |
|---|---|---|
| JWCAR201 arm | Experimental | Biological: JWCAR201Subjects in this arm will receive intervention with JWCAR201 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
- aged >= 18 years
- willing to sign ICF
- with histologically confirmed large B cell lymphoma and immunohistochemically positive CD20
- The subject must have previously been treated with an anthracycline and rituximab (or another CD20-targeted therapy), and must have relapsed, not achieved remission, or experienced disease progression after receiving at least two lines of therapy, including autologous hematopoietic stem cell transplantation (autoHSCT)
Key exclusion criteria (26 listed)
- For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
- 1. Primary central nervous system (CNS) lymphoma (subjects with secondary CNS lymphoma are allowed to enroll).
- 2. A history of another malignancy that has not been in complete remission for at least 2 years (the following conditions are exempt from the 2-year restriction: non-melanoma skin cancer, completely resected stage I tumors with a low likelihood of recurrence, treated localized prostate cancer, biopsy-confirmed in situ cervical cancer, or squamous intraepithelial lesions identified on a PAP smear).
- Hepatitis B surface antigen (HBsAg) positivity (regardless of whether or not there is an increase in hepatitis B virus DNA copies).
- Hepatitis B core antibody (HBcAb) positivity with an increase in hepatitis B virus DNA copies.
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 |
|---|---|---|
| JWCAR201JWCAR201 is a autologous CAR-T targeting CD19/CD20 | Biological | JWCAR201 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.
the rate of AE and SAE
Time frame: up to 2 years
any adverse event (AE) or serious adverse event (SAE) occurring after JWCAR201 administration
18 secondary outcomes
the change of number of JWCAR201 cells by measuring the cell number and the number of transgene copies over time
Time frame: from baseline up to 2 years
the change of numbers of B cell subtypes (e.g., CD19+, CD20+ B cells) in the blood
Time frame: from baseline up to 2 years
overall response rate (ORR) in subjects with hematology malignancy
Time frame: from baseline up to 2 years
complete response rate (CRR) in subjects with hematology malignancy
Time frame: from baseline up to 2 years
duration of response in subjects with hematology malignancy
Time frame: from baseline up to 2 years
progression free survival in subjects with hematology malignancy
Time frame: from baseline up to 2 years
Overall survival in subjects with hematology malignancy
Time frame: from baseline up to 2 years
the proportion of subjects achieving LLDAS in subjects with SLE
Time frame: from baseline up to 2 years
the proportion of subjects achieving DORIS in subjects with SLE
Time frame: from baseline up to 2 years
the proportion of subjects achieving SRI-4 in subjects with SLE
Time frame: from baseline up to 2 years
the change of BILAG-2004 score in subjects with SLE
Time frame: from baseline up to 2 years
the change of Physician's global assessment (PGA) score in subjects with SLE
Time frame: from baseline up to 2 years
the change of SLE-DAS score in subjects with SLE
Time frame: from baseline up to 2 years
the proportion of subjects without other SLE therapies
Time frame: from baseline up to 2 years
The change of fatigue score in subjects with SLE
Time frame: from baseline up to 2 years
The change from baseline in immunoglobulins (IgA, IgE, IgG, IgM)
Time frame: from baseline up to 2 years
the change from baseline in complements (C3, C4)
Time frame: from baseline up to 2 years
The change from baseline in auto-antibodies (anti-dsDNA antibody, ANA)
Time frame: from baseline up to 2 years
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 22 Aug 2024.
- 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.
Liangjing Lu principal investigator
RenJi 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 JWCAR201 in people with B-cell Tumors and Autoimmune Diseases, run by RenJi 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 14 inclusion and 26 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 22 Aug 2024. 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 Liangjing Lu (86-13661472001, Lu_liangjing@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 22 Aug 2024.