[Anti-CD19 CART (C-CAR011) Therapy for Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma]

To evaluate the safety and efficacy of C-CAR011 in the treatment of relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL) patients.

B-NHL patients treated with C-CAR011 infusion following lympho-depletion were enrolled. All the patients were followed up for 1 year after C-CAR011 treatment(5.0×10⁶ /kg). The primary endpoint of this research was safety; and the secondary endpoints included objective response rate (ORR), progression-free survival (PFS), duration of overall response (DOR), overall survival (OS) at Week 4, 12 and Month 6 and 12.

The ratio of the male and female of 6 patients was 1∶1, and the patients were treated with C-CAR011 at a dose of 5.0×10⁶ /kg. The median age was 46.5 years old (37-62 years); 5 patients were diagnosed as diffuse large b-cell lymphoma (DLBCL) and 1 patient was diagnosed as follicular lymphoma (FL). The most common adverse events (AEs) were hematological toxicities (100%, Grade 3-4), cytokine release syndrome (CRS) (66.7%, Grade 1-3), neurotoxicity (16.7%, Grade 3). All these AEs were reversible and could be conversed. The ORR at Week 4, 12 and Month 6, 12 were 50%(3/6), 50%(3/6), 16.7%(1/6) and 16.7%(1/6), respectively. Three patients (50%) achieved complete response (CR) and one of them stayed evaluated as CR until Month 12. The median PFS was 178 days (91->365 days). For 3 patients with response, the DOR were 150 days, 154 days and >12 months, respectively. The OS rates of the patients at Week 12, Month 6, 12 were 100%, 100%, 83.3%, respectively, while the median OS was not reached.

C-CAR011 is a safe treatment option for R/R B-NHL; some patients could achieve long-term sustained responses after C-CAR011 infusion（ClinicalTiral.gov number, NCT03483688）.