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)
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.
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).
Acute deep vein thrombosis (DVT) (tumor thrombus or thrombus) or pulmonary embolism (PE) within 3 months prior to informed consent signing.
Single group
JWCAR239
Biological/VaccineA single infusion of chimeric antigen receptor (CAR)-transduced autologous T cells targeting CD19/CD20
Fludarabine
DrugAdministered according to package insert
Cyclophosphamide
DrugAdministered according to package insert
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.
AE and SAE rate
ny adverse event (AE) or serious adverse event (SAE) occurring after JWCAR239 administration
Pharmacokinetic (PK)- Cmax of JWCAR239
Maximum observed concentration of JWCAR239 in peripheral blood
PD
Peripheral blood levels of CD19+ and/or CD20+ B cells
overall response rate (ORR)
ORR is the proportion of subjects who achieve positive response to the treatment. It includes complete response and partial response.
complete response rate (CRR)
CRR refers to the proportion of subjects whose cancer signs disappear
The change of serum cytokines concentration
The change of serum cytokines concentration after JWCAR239 infusion
Click on the lead sponsor to view all of their trials.
Peking University Cancer Hospital & Institute
Lead sponsor
Shanghai JW Therapeutics Co., Ltd.
Collaborator
This trial is not recruiting at the moment. You can still explore other options:
