JWCAR201 for the Treatment of Hematology Malignancy and Autoimmune Diseases
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorRenJi Hospital
About this trial
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
Eligibility criteria
Qualifiers
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)
Disqualifiers
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.
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.
Severe lupus nephritis requiring hemodialysis within 2 months before screening, or treatment with prednisone ≥ 100 mg/day or equivalent corticosteroids for ≥ 14 days.
Trial design
Treatments tested in this trial
- JWCAR201
Treatment groups
15 Participants
are divided into 1 treatment groupSponsors and collaborators
RenJi Hospital
Lead sponsor
Shanghai Ming Ju Biotechnology Co., Ltd.
Collaborator
Source ClinicalTrials.gov