614. Acute Lymphoblastic Leukemia: Therapy, excluding Transplantation: Chimeric Antigen Receptor T Cell Therapy
Junfang Yang, Pengfei Jiang, Xian Zhang, et al.
Authors Conclusion from the Abstract: This study demonstrated that anti-CD19/CD22 dual CAR T-cells could be successfully manufactured by FasTCARTM technology in 24 hours, with younger and less exhausted phenotypes. Moreover, the Dual FasTCAR-T cells showed more potent efficacy in xenograft mouse model compared to the conventional dual CAR-T cells. Our clinical data demonstrate that GC022F is safe and efficacious in treating patients with CD19+CD22+ B-ALL. More data on additional patients and longer observation time are needed to further evaluate CD19/CD22 dual FasTCAR-T cell product.
Claire Roddie, PhD, MD1*, Maeve A O'Reilly, MBBCHBAO2, Maria A V Marzolini, et al.
Authors Conclusion from the Abstract: AUTO1 has a tolerable safety profile in adult patients with r/r B-ALL despite high disease burden. Early data shows high remission rates with 84% achieving MRD negative CR. This preliminary data supports the further development of AUTO1 as a standalone treatment in patients with r/r B-ALL. Data from additional patients and longer follow up will be presented. Furthermore, data from extension cohorts of patients with low- and high- grade B-cell Non-Hodgkin’s lymphoma and chronic lymphocytic leukaemia will be presented.
Xian Zhang, Junfang Yang, Wenqian Li, et al.
Authors Conclusion from the Abstract: We find that manufacturing CD19+ CAR-T cells derived from donors is feasible. For patients who relapse following allo-HSCT, the transplant donor derived CAR-T cells are safe and effective with a CR rate as high as 96.4%. If a patient did not have GVHD prior to CAR T-cell therapy, the incidence of GVHD following CAR T-cell was low. Among patients without a history of transplantation, an inability to collect autologous lymphocytes signaled that the patient's condition had already reached a very advanced stage. However, CAR T-cells derived from HLA identical siblings can still be considered in our experience, no GVHD occurred in these patients. But the efficacy of CAR T-cells from haploidentical donors was very poor.
Rui Zhang, Juan Xiao, Zhouyang Liu, et al.
Authors Conclusion from the Abstract: This study focuses on CAR-T cell therapy following relapse after HCT. While the expanded study is ongoing, we present the results of the first 20 pts. Use of donor-derived or recipient-derived CAR-T products in pts who relapsed after allo-HCT is well tolerated and it may prolong life expectancy of these pts while maintaining a good quality of life.
Nitin Jain, Gail J. Roboz, Marina Konopleva, et al.
Authors Conclusion from the Abstract: UCART22 demonstrated no unexpected toxicities at doses of 1x105/kg and 1x106/kg with FC LD regimen. CRS was observed in 3 patients, all grade 1-2, and was manageable. No pts had DLT, GvHD nor ICANS. Two pts achieved CRi. As host immune recovery was observed early, the addition of alemtuzumab to FC LD is now being explored in ongoing treatment cohorts to potentially achieve a deeper and more sustained T-cell depletion and promote expansion and persistence of UCART22. Enrollment is ongoing.
Erica Brivio, Franco Locatelli, Adriana Thano, et al.
Authors Conclusion from the Abstract: InO was well tolerated in this Ph II study which confirmed remarkable activity in these heavily pretreated pts. The ORR was 81.5% with 95% MRD-negativity; 55% of pts remained alive after 1 year. Twelve pts proceeded to consolidation treatment (either HSCT or CAR T). In contrast with the Ph I cohort (where no pts developed SOS post 7 HSCTs), 3 cases of SOS were recorded here after 9 HSCTs.
A Ph I cohort of this study combining InO with chemotherapy in R/R pediatric ALL is ongoing.