The study is a Phase II, single-arm, open-label, single-dose clinical trial, and its primary objective is to evaluate the efficacy and safety of CNCT19 Cell Injection in the treatment of relapsed or refractory NHL.
Patients who are willing to sign the informed consent form;
Aged 18-75 years, male or female;
Diffuse large B cell lymphoma (DLBCL), not otherwise specified (NOS);
Primary mediastinal large B cell lymphoma (PMBCL);
Patients with active central nervous system (CNS) lymphoma (a patient with CNS disease symptoms must receive lumbar puncture and MRI/CT to exclude CNS lymphoma).
Patients with existing central nervous system disease or with a history of central nervous system disease, e.g., epileptic seizure, cerebral ischemia/hemorrhage, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellum disease, organic brain syndrome, mental disease, or any autoimmune disease involved with central nervous system.
Alemtuzumab within 6 months prior to apheresis;
Cladribine within 3 months prior to apheresis;
Single group
single dose of CNCT19
Biological/VaccineDose: 2.00 x 10\^8 CNCT19 Cell Injection via intravenous infusion. Drug: Fludarabine Drug: Cyclophosphamide
Overall Remission Rate (ORR), which includes Complete Remission (CR) and Partial Remission (PR)
Efficacy of CNCT19 as measured by ORR at the 3 months after CNCT19 Cell Injection infusion, which includes CR and PR.
CR rate at 3 months after CNCT19 infusion
Efficacy of CNCT19 as measured by CR during the 3 months after CNCT19 Cell Injection infusion.
ORR（CR+PR）/CR
ORR（CR+PR）/CR
Progression-free survival (PFS)
PFS means duration from the CNCT19 Cell Injection infusion to progression of lymphoma, or death for any reason.
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