Trial Title:
JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases
NCT ID:
NCT06567080
Condition:
B-cell Tumors
Autoimmune Diseases
Lupus Erythematosus, Systemic
Large B-cell Lymphoma
Conditions: Official terms:
Lupus Erythematosus, Systemic
Autoimmune Diseases
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
JWCAR201
Description:
JWCAR201 is a autologous CAR-T targeting CD19/CD20
Arm group label:
JWCAR201 arm
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
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
For subjects with B cell driven malignancy (relapsed/refractory large B cell lymphoma)
1. aged >= 18 years
2. willing to sign ICF
3. with histologically confirmed large B cell lymphoma and immunohistochemically
positive CD20
4. 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)
5. The subject must have CT measurable lesions and PET evaluable lesions as determined
by the Lugano criteria.
6. The subject must have an Eastern Cooperative Oncology Group (ECOG) performance
status of 0 or 1.
For subjects with SLE:
1. Voluntarily sign the informed consent form (ICF).
2. 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.
3. Have been diagnosed with SLE (Systemic Lupus Erythematosus) for ≥ 6 months before
screening, according to the 2019 EULAR/ACR revised criteria
4. 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.
5. At the time of screening, positive for antinuclear antibodies (ANA), and/or
anti-dsDNA antibodies, and/or anti-Smith antibodies.
6. SLEDAI-2K score ≥ 7 points during the screening period.
Exclusion Criteria:
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:
1. Hepatitis B surface antigen (HBsAg) positivity (regardless of whether or not there
is an increase in hepatitis B virus DNA copies).
2. Hepatitis B core antibody (HBcAb) positivity with an increase in hepatitis B virus
DNA copies.
3. 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:
1. Severe lupus nephritis requiring hemodialysis within 2 months before screening, or
treatment with prednisone ≥ 100 mg/day or equivalent corticosteroids for ≥ 14 days.
2. Lupus crisis within 1 month before screening, deemed unsuitable for participation in
this study by the investigator.
3. 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.
4. Concurrent other autoimmune diseases requiring systemic treatment.
5. History of major organ transplantation (e.g., heart, lung, kidney, liver) or
hematopoietic stem cell/bone marrow transplantation.
6. 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)).
Gender:
All
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Renji Hospital, Shanghai Jiaotong University School of Medicine
Address:
City:
Shanghai
Zip:
200001
Country:
China
Start date:
September 2024
Completion date:
March 2027
Lead sponsor:
Agency:
RenJi Hospital
Agency class:
Other
Collaborator:
Agency:
Shanghai Ming Ju Biotechnology Co., Ltd.
Agency class:
Industry
Source:
RenJi Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06567080
