CD19-targeted CAR T Cells （JWCAR029） for Primary Refractory Diffuse Large B Cell Lymphoma

Inclusion Criteria:

1. ≥ 18 years old;
2. Sign on the informed consent;
3. Subject must have histologically confirmed diffuse large B lymphoma and primary refractory with first-line therapy;
4. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
5. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1;
6. Adequate organ function;
7. Adequate vascular access for leukapheresis procedure;
8. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still express CD19;
9. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of JWCAR029;
10. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of JWCAR029

Exclusion Criteria:

1. Subjects who have received second-line treatment or above
2. CD19 negative
3. Primary CNS lymphoma;
4. History of another primary malignancy that has not been in remission for at least 2 years;
5. Subjects has HBV, HCV, HIV or syphilis infection at the time of screening;
6. Deep venous thrombosis (DVT)/Pulmonary embolism (PE), or DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
7. Subjects with uncontrolled systemic fungal, bacterial, viral or other infection;
8. Presence of acute or chronic graft-versus-host disease (GVHD);
9. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
10. Pregnant or nursing women;
11. Subjects using of any chemotherapy, corticisteriod, experiment agents, GVHD therapies, radiation, allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
12. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
13. Received CAR T-cell or other genetically-modified T-cell therapy previously.