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DRUG:

SENL-B19

i
Other names: SENL-B19, autologous CD19-targeting CAR T cell therapy, SENL-B-19
Associations
Company:
SenlangBio
Drug class:
CD19-targeted CAR-T immunotherapy
Related drugs:
Associations
over3years
Promoter usage regulating the surface density of CAR molecules may modulate the kinetics of CAR-T cells in vivo. (PubMed, Mol Ther Methods Clin Dev)
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.
Preclinical • Journal • CAR T-Cell Therapy
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IFNG (Interferon, gamma)
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SENL-B19
4years
[VIRTUAL] Significant Long-Term Benefits of CAR T-Cell Therapy Followed By a Second Allo-HSCT for Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) Patients Who Relapsed after an Initial Transplant (ASH 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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fludarabine IV • busulfan • cyclosporin A microemulsion • cyclosporine • SENL-B19 • cyclophosphamide intravenous
4years
[VIRTUAL] A Feasibility and Safety Study of a Novel CD19-Directed Synthetic T-Cell Receptor and Antigen Receptor (STAR) T-Cell Therapy for Refractory and Relapsed (R/R) B Cell Acute Lymphoblastic Leukemia (B-ALL) (ASH 2020)
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.
Clinical
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CD19 (CD19 Molecule)
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fludarabine IV • YT-19 • SENL-B19
4years
[VIRTUAL] Feasibility, and Efficacy of Donor-Derived cd19-Targeted Car t-Cell Therapy in Refractory/Relapsed(r/r)b-Cell Acute Lymphoblastic Leukemia (b-all) Patients (ASH 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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SENL-B19
over4years
[VIRTUAL] CD19-TARGETED CAR-T CELL THERAPY FOR 32 B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) PATIENTS WHO RELAPSED AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (ALLO-HSCT) (EBMT 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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fludarabine IV • SENL-B19
over4years
[VIRTUAL] CD19-TARGETED CAR-T CELL THERAPY FOR 32 B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) PATIENTS WHO RELAPSED AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (ALLO-HSCT) (EBMT 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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fludarabine IV • SENL-B19
over4years
[VIRTUAL] CD19-TARGETED CAR-T CELL THERAPY FOR 32 B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) PATIENTS WHO RELAPSED AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (ALLO-HSCT) (EBMT 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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fludarabine IV • SENL-B19
over4years
[VIRTUAL] MONITORING 24 CYTOKINES BY CYTOMETRIC BEAD ARRAY DURING THE CHIMERIC ANTIGEN RECEPTOR T CELLS TREATMENT (EHA 2020)
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).
CAR T-Cell Therapy • IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL10 (Interleukin 10)
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SENL-B19
almost5years
[VIRTUAL] CD19-TARGETED CAR-T CELL THERAPY FOR 32 B-CELL ACUTE LYMPHOBLASTIC LEUKEMIA (B-ALL) PATIENTS WHO RELAPSED AFTER ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION (ALLO-HSCT) (EBMT 2020)
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.
Clinical • CAR T-Cell Therapy
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CD19 (CD19 Molecule)
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fludarabine IV • SENL-B19
5years
A Feasibility and Safety Study of a New CD19-Directed Fast CAR-T Therapy for Refractory and Relapsed B Cell Acute Lymphoblastic Leukemia (ASH 2019)
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.
Clinical • PD(L)-1 Biomarker • IO biomarker
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PD-1 (Programmed cell death 1) • IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • IL10 (Interleukin 10)
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fludarabine IV • SENL-B19
5years
Analysis of Factors Predicting Treatment Response of 254 Patients Who Received CD19-Targeted CAR-T Cell Therapy for Relapsed/Refractory (R/R) B-Cell Acute Lymphoblastic Leukemia (B-ALL) (ASH 2019)
The CR rate of patients who received prior either CAR-T or blinatumomab treatment was lower than those who had not (50% vs. 91.53%, p=0.01)...There were no differences in CR between patients age 1-14 yr and >14 yr, patients with or without extramedullary disease (EMD), or patients receiving different chemotherapies between enrollment and CAR-T cells infusion on top of fludarabine and cyclophosphamide (FC) conditioning regimen...Patients who developed severe neurotoxicity (grade 2-4) post CAR-T had higher odds of achieving CR compared to patients with grade 0-1 neurotoxicity [OR=34.796(95%CI 3.232-374.659)]. Conclusions In this analysis, we have observed that significant risk factors for not achieving CR after CD-19 CAR-T therapy include female gender, BM blasts more than 20%, a positive TP53 mutation, treatment with CD28 co-stimulatory domain vs 4-1BB CAR-T product, and mild as opposed to severe CAR-T related neurotoxicity.
Clinical • CAR T-Cell Therapy • IO biomarker
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TP53 (Tumor protein P53) • CD8 (cluster of differentiation 8)
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Blincyto (blinatumomab) • fludarabine IV • SENL-B19
5years
Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia (ASH 2019)
All pts received conditioning regimen of fludarabine and cyclophosphamide intravenously for 3 consecutive days with doses of 30 mg/m2/day and 250 mg/m2/day, respectively before a single infusion of CAR-T cells...A low toxicity with dose-dependent high CR rate including pts who previously treated with CD19 CAR-T cells were observed. Longer observation time and more patients are needed to evaluate a beneficial advantage of the CD19/CD22 dual CAR-T over CD19 CAR-T product.
IO biomarker
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IFNG (Interferon, gamma) • IL6 (Interleukin 6) • IL2RA (Interleukin 2 receptor, alpha) • IL10 (Interleukin 10)
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fludarabine IV • GC007F • SENL-B19