S1904 / SenlangBio - LARVOL DELTA

Frank W Clarke and the birth of meta-analysis (ACS-Fall 2026) - "While Karl Pearson's 1904 work has long been regarded as the "first" example of this kind, Frank Wigglesworth Clarke's 1882 Recalculation of the Atomic Weights includes many meta-analyses that pre-date Pearson's...Clarke's vision was to take all of these hundreds of ratios, "old and new, good, bad and indifferent," and blend them in a way that neither makes assumptions about the values of any atomic weights nor is "affected by the glamour of great names." In doing so, Clarke provided one of the earliest and most significant examples of large-scale meta-analysis in the physical sciences, employing general-purpose statistical methods similar to those that CODATA uses nowadays to produce recommended values of the fundamental physical constants. Clarke's 1882 landmark compilation of results for the atomic weights, and his systematic, meta-analytical recalculations harmonized the atomic weights across the Periodic Table and..."

Retrospective data

Barriers and Facilitators of Oral PrEP Uptake Against HIV Among Selected Priority Populations: A Global Perspective. (PubMed, Curr HIV/AIDS Rep) - "PrEP must be positioned not merely as a clinical tool, but as a cornerstone of an equity-driven HIV prevention architecture. The online version contains supplementary material available at 10.1007/s11904-026-00783-2."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease

Assessment of Senl_B19 CAR-T Cells in Relapsed/Refractory CD19+ B-ALL (clinicaltrials.gov) - P2 | N=59 | Recruiting | Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

New P2 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology

Safety and Efficacy of CD 19 CAR T Cells (S1904) in Patients with RR B-ALL: A Pooled Analysis of Two Early-Phase Trials (ASH 2024) - P1 | "Key enrolment criteria included CD 19+ RR B-ALL patients (aged 3 years and above) who had failed multiple therapy lines and had adequate organ functions.Upon enrollment, patients received lymphodepleting chemotherapy with fludarabine (25mg/m2 daily for 3 days) and cyclophosphamide (500mg/m2 daily for 2 days), followed by a single infusion of S1904...All CRS cases were rapidly resolved with conventional interventions, including tocilizumab and steroids...With Senlang's cost-effective manufacturing process, making cell therapy accessible to most patients is not an unattainable goal. Additionally, the observed benefits of combining CD19 CAR-T therapy with bridging allo-HSCT warrant further confirmation in future studies."

CAR T-Cell Therapy • Retrospective data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Hematological Malignancies • Leukemia • Oncology

Surface Density of CAR Molecules May Modulate the Kinetics of CAR-T Cells In Vivo (ASH 2019) - P1; "The expression levels of tEGFR and CAR were determined by flow cytometry using the biotinylated-Erbitux, and the CD19-Fc protein and the α-FMC63scFv antibody, respectively...All subjects were preconditioned with fludarabine and cyclophosphamide before 3x105 CAR-T cells/kg infusion... Using the myeloproliferative sarcoma virus enhancer, we have generated a lentivirus vector, 1904B that can express CAR at a lower level on the cell surface, and investigated 1904B CAR-T functions in cell culture, in a mouse model, and in patients. Lower surface expression of CAR was found with reduced cytotoxicity and lower cytokine release of CAR-T in cell culture, but prolonged T cell activity in a mouse model. Human subjects treated with 1904B CAR-T developed fever later and shorter than 1904A, with slower expansion of CAR-T cells."

CAR T-Cell Therapy • IO biomarker • Preclinical • Myelodysplastic Syndrome • Oncology • Sarcoma • Solid Tumor • IFNG

[VIRTUAL] An Anti-Bcma CAR T-Cell Therapy (C-CAR088) Shows Promising Safety and Efficacy Profile in Relapsed or Refractory Multiple Myeloma (ASH 2020) - P1 | "C-CAR088 is administered to patients as a single intravenous dose after a standard 3-day cyclophosphamide/fludarabine conditioning regimen...Four patients (19%) received tocilizumab for CRS treatment... The clinical trial results in patients with R/R MM treated with C-CAR088 show a favorable safety profile and promising signs of efficacy. We will continue to evaluate these patients to understand the long-term effect of C-CAR088 in multiple myeloma patients. Clinical trial information: NCT04322292、NCT03815383、NCT03751293、NCT04295018 Research Sponsor: Cellular Biomedicine Group, Inc."

CAR T-Cell Therapy • Clinical • Hematological Malignancies • Multiple Myeloma • Oncology

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) - P1, P1/2; "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."

CAR T-Cell Therapy • Clinical • IO biomarker • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Immune Modulation • Immunology • Inflammation • Leukemia • Oncology • CD8 • MLL • TP53

[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) - P1, P1/2 | "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."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • Atrial Fibrillation • B Acute Lymphoblastic Leukemia • Cardiovascular • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD19

[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) - P1, P1/2 | "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..."

CAR T-Cell Therapy • Clinical • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD19

Which is better in CD19 CAR-T treatment of r/r B-ALL, CD28 or 4-1BB? A parallel trial under the same manufacturing process. (ASCO 2018) - P1/2; "...KYMRIAH and YESCARTA used 4-1BB and CD28 co-stimulatory signaling domains, respectively... The study illustrates that 4-1BB CAR-T cells show enhanced safety, efficacy, and expansion than CD28 CAR-T cells, suggesting a superior therapeutic strategy in the treatment of relapsed or refractory CD19-positive B-ALL patients."

Acute Lymphocytic Leukemia

Efficacy and Safety of CD19 Chimeric Antigen Receptor (CAR) T Cell Therapy for B-Cell Acute Lymphocytic Leukemia (B-cell ALL) in a Large Cohort Including Patients with Extramedullary Disease(EMD), High Leukemia Burden, BCR-ABL (+) Mutation,TP53 Mutation, and Post-Transplant Relapse (ASH 2018) - P1/2; "...All pts received a conditioning regimen of IV fludarabine (25 mg/m2/day) and cyclophosphamide (250 mg/m2/day) for 3 days before a single infusion of CAR-T cells with a median dose of 1x105 (0.1-10x105) cells/kg...An early and high relapse rate was observed in TP53+ group. Overall, RFS was superior for pts bridging to allo-HSCT after CAR-T treatment than for those receiving CAR-T- treatment only."

Clinical • Acute Lymphocytic Leukemia • Biosimilar • Brain Cancer • Chronic Myeloid Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation

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) - P1; "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 • IO biomarker • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Transplantation • IFNG • IL10 • IL2RA • IL6 • PD-1

Anti-CD19/CD22 Dual CAR-T Therapy for Refractory and Relapsed B-Cell Acute Lymphoblastic Leukemia (ASH 2019) - P1; "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 • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Oncology • Pediatrics • IFNG • IL10 • IL2RA • IL6

[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) - P1 | "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 • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation • CD19

[VIRTUAL] Successful 24-Hours Manufacture of Anti-CD19/CD22 Dual Chimeric Antigen Receptor (CAR) T Cell Therapy for B-Cell Acute Lymphoblastic Leukemia (B-ALL) (ASH 2020) - P1 | "All patients received a conditioning regimen of IV fludarabine (25mg/m2/d) and cyclophosphamide (250mg/m2/d) for 3 days prior to GC022F infusion...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."

Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CCR7 • LAG3 • PD-1

Integrating CAR T-Cell Therapy and Transplantation: Comparisons of Safety and Long-Term Efficacy of Allogeneic Hematopoietic Stem Cell Transplantation After CAR T-Cell or Chemotherapy-Based Complete Remission in B-Cell Acute Lymphoblastic Leukemia. (PubMed, Front Immunol) - "Despite the inclusion of more patients with advanced diseases in the CAR-T group, the 4-year LFS and OS achieved with CAR T-cells followed by allo-HSCT were as remarkable as those achieved with chemotherapy followed by allo-HSCT. Further confirmation of these results requires larger, randomized clinical trials."

CAR T-Cell Therapy • Clinical • Journal • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation • CD19

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) - P1 | "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."

CAR T-Cell Therapy • Journal • Preclinical • Hematological Malignancies • Leukemia • Oncology • IFNG

Senl-h19 CAR-T Cell Injection in the Treatment of Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P=N/A; N=15; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Clinical • New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19 • CD7 • IL10 • IL6

Senl_1904A and Senl_1904B Chimeric Antigen Receptor （CAR） T-Cell in the Treatment of r/ r Acute B Lymphocytic Leukemia (clinicaltrials.gov) - P1; N=20; Active, not recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.; Recruiting ➔ Active, not recruiting; Trial completion date: Jan 2020 ➔ Jan 2022; Trial primary completion date: Sep 2019 ➔ Sep 2021

Clinical • Enrollment closed • Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • CD19

Adult B-ALL Treated by CART Cell Bridging Allogeneic Hematopoietic Stem Cell Transplantation (clinicaltrials.gov) - P1; N=50; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Clinical • New P1 trial • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukaemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia Using CD7-Specific CAR-T Cells (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.; Not yet recruiting ➔ Recruiting

Enrollment open • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7

Cell Therapy for CD7 Positive T-cell Acute Lymphoblastic Leukemia Using CD7-Specific CAR-T Cells (clinicaltrials.gov) - P=N/A; N=20; Not yet recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • T Acute Lymphoblastic Leukemia • CD7

Immunotherapy With BCMA CAR-T Cells in Treating Patients With Relapsed or Refractory Multiple Myeloma (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.; Trial completion date: Dec 2020 ➔ Dec 2022; Trial primary completion date: Aug 2020 ➔ Aug 2022

Clinical • Trial completion date • Trial primary completion date • Hematological Malignancies • Multiple Myeloma • Oncology

Safety and Efficacy Study of SL1904B CAR-T Cells for Relapsed or Refractory B-Cell Acute Lymphocyte Leukemia (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Clinical • New trial • Hematological Malignancies • Leukemia • Oncology • CD19

Safety and Efficacy Study of CD22 CAR-T Cells for Relapsed or Refractory Acute Lymphoblastic Leukemia (clinicaltrials.gov) - P=N/A; N=20; Recruiting; Sponsor: Hebei Senlang Biotechnology Inc., Ltd.

Clinical • New trial • Acute Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology