S1904

P2, N=59, Recruiting, Hebei Senlang Biotechnology Inc., Ltd.

These results represent the first comprehensive study on the promoter-driven modulation of CAR-T cell functionality. These findings encourage further evaluation of the potential of the MND promoter to drive CAR-T cells as a broadly applicable cellular product for anticancer immunotherapy.

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single CAR T-cell infusion with a median dose of 3×105 cells/kg (1×105-6×105 cells/kg) in 21 patients...Post CAR-T therapy, all patients bridged into a consolidation second transplantation with conventional myeloablative pre-transplantation conditioning regimens including 15 patients who received total body irradiation-based and 7 patients that received a busulfan-based conditioning regimen. Cyclosporin A, short-term methotrexate, and mycophenolate mofetil were used for GVHD prophylaxis...Conclusions Our study demonstrates that even for R/R B-ALL patients who have relapsed following a first allo-HSCT , an MRD-negative CR status can still be achieved through CAR T-cell cell therapy without increasing CRS or neurotoxicity, making consolidation second allo-HSCT feasible for these patients. CAR T-cell therapy combined with a consolidation second HSCT are effective for these heavily pre-treated patients with an encouraging prospect for long-term survival.

Here, we report pre-clinical and first-in-human phase I trial results of CD19 STAR-T cell therapy for CD19+ R/R B-ALL...Patients received a conditioning regimen of IV fludarabine (25mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single STAR T-cell infusion...A high CR could be achieved on day 14 with low toxicity. Longer-term observation of these patients and studies of larger patient cohorts are warranted.

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.

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single infusion of CAR-T cells with a median dose of 2 x105 (0.083-10x105) cells/kg... Our study demonstrates that a high CR rate can still be achieved through CAR-T therapy even for those who relapsed after allo-HSCT without increasing CRS or neurotoxicity. A second consolidation allo-HSCT may be considered for those who achieved MRD-negative CR after CAR-T. Receiving CAR-T cells that manufactured from transplant donors may result in a trend towards higher GVHD rate compared to autologous CAR-T cells.

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single infusion of CAR-T cells with a median dose of 2 x105 (0.083-10x105) cells/kg... Our study demonstrates that a high CR rate can still be achieved through CAR-T therapy even for those who relapsed after allo-HSCT without increasing CRS or neurotoxicity. A second consolidation allo-HSCT may be considered for those who achieved MRD-negative CR after CAR-T. Receiving CAR-T cells that manufactured from transplant donors may result in a trend towards higher GVHD rate compared to autologous CAR-T cells.

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single infusion of CAR-T cells with a median dose of 2 x105 (0.083-10x105) cells/kg... Our study demonstrates that a high CR rate can still be achieved through CAR-T therapy even for those who relapsed after allo-HSCT without increasing CRS or neurotoxicity. A second consolidation allo-HSCT may be considered for those who achieved MRD-negative CR after CAR-T. Receiving CAR-T cells that manufactured from transplant donors may result in a trend towards higher GVHD rate compared to autologous CAR-T cells.

Conclusion Although ELISA and CBA were all liable techniques for monitoring cytokines in CAR-T treatment, CBA shew a strong power in detecting 24 cytokines in all samples even in paucicellular specimens. The advantages of CBA over ELISA were user-friendly, low cost, highly efficient, and specimen saving, especially in evaluation of urgent single sample and paucicellular specimens, such as cerebrospinal fluid (CSF).

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single infusion of CAR-T cells with a median dose of 2 x105 (0.083-10x105) cells/kg... Our study demonstrates that a high CR rate can still be achieved through CAR-T therapy even for those who relapsed after allo-HSCT without increasing CRS or neurotoxicity. A second consolidation allo-HSCT may be considered for those who achieved MRD-negative CR after CAR-T. Receiving CAR-T cells that manufactured from transplant donors may result in a trend towards higher GVHD rate compared to autologous CAR-T cells.

All patients received a conditioning regimen of IV fludarabine (30mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days followed by a single infusion of CAR-T cells...Conclusion This study has demonstrated that FasT CAR-T cells with superior expansion capability and younger/less exhausted phenotypes can be generated rapidly. This first-in-human clinical study showed that FasT CAR-T is safe and highly effective for treating patients with B-ALL.