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  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Trial primary completion date:  Orphan Indications for CD19 Redirected Autologous T Cells (clinicaltrials.gov) -  Dec 20, 2023   
    P2,  N=81, Recruiting, 
    Trial completion date: Aug 2024 --> Jun 2027 | Initiation date: Feb 2024 --> Jun 2024 | Trial primary completion date: Aug 2024 --> Jun 2026 Trial primary completion date: Mar 2025 --> Mar 2028
  • ||||||||||  huCART19 / Novartis, CART22 / University of Pennsylvania
    Trial completion date, Trial primary completion date:  Co-administration of CART22-65s and huCART19 for B-ALL (clinicaltrials.gov) -  Dec 19, 2023   
    P1/2,  N=93, Recruiting, 
    Importantly, as shown by our study, metabolic tumor burden might facilitate CAR T-cell product selection and reflect the individual need for bridging therapy. Trial completion date: Jan 2026 --> Jan 2029 | Trial primary completion date: Jan 2025 --> Jan 2027
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Journal:  CAR-T therapy for adult B-cell acute lymphoblastic leukemia (Pubmed Central) -  Dec 17, 2023   
    We have already used tisagenlecleucel in clinical practice, but it is limited to patients up to 25 years of age. This review summarizes the most recent evidence on CAR-T therapy for relapsed or refractory adult B-ALL, which has a poor prognosis when assessed in younger patients.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Journal:  CAR-T therapy for malignant lymphoma (Pubmed Central) -  Dec 17, 2023   
    Salvage chemoimmunotherapy followed by high-dose chemotherapy and autologous stem cell rescue is the standard of care for chemo-sensitive and transplant-eligible R/R DLBCL. This review highlights the approved CAR-T constructs, including their efficacy, adverse effects, and real-world data.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Journal:  CAR-T therapy for pediatric acute lymphoblastic leukemia (Pubmed Central) -  Dec 17, 2023   
    Several studies have been published in the last 2-3 years that discuss risk factors for relapse after tisagenlecleucel and the need for consolidative therapy. This manuscript presents the direction of these discussions and perspectives.
  • ||||||||||  CD19.CAR-T / Nagoya University Graduate School of Medicine, Kymriah (tisagenlecleucel-T) / Novartis
    Journal:  Challenges and prospects for CAR-T therapy (Pubmed Central) -  Dec 17, 2023   
    The current challenge for CAR-T therapy is insufficient response, as about 50% of patients who receive CD19 CAR-T therapy eventually relapse or become refractory...Additionally, the development of novel CAR-T therapies is also desired. In this article, we discuss the current status and future prospects of these issues, including our own efforts.
  • ||||||||||  birinapant (IGM-9427) / IGM Biosciences
    Journal:  The SMAC mimetic birinapant alleviates lipopolysaccharide-induced acute lung injury by inhibiting MAPK signaling. (Pubmed Central) -  Dec 17, 2023   
    At last, birinapant suppressed the activation of mitogen-activated protein kinase (MAPK) signaling pathway and K48-linked ubiquitinated degradation of TRAF3 in MH-S cells after LPS administration. In conclusion, the results proved that birinapant protected against LPS-induced ALI through inhibiting MAPK activation and K48-linked ubiquitination of TRAF3 in alveolar macrophages.
  • ||||||||||  Keytruda (pembrolizumab) / Merck (MSD), aDC1 vaccine / Roswell Park, University of Pittsburgh
    Trial completion date, Trial primary completion date, Metastases:  Dendritic Cell-Based Treatment Plus Immunotherapy for the Treatment of Metastatic or Unresectable Triple Negative Breast Cancer (clinicaltrials.gov) -  Dec 15, 2023   
    P2,  N=19, Not yet recruiting, 
    In conclusion, the results proved that birinapant protected against LPS-induced ALI through inhibiting MAPK activation and K48-linked ubiquitination of TRAF3 in alveolar macrophages. Trial completion date: Sep 2025 --> Jan 2026 | Trial primary completion date: Sep 2025 --> Jan 2026
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Early Versus Late CAR-T Therapy in Large B-Cell Lymphoma: Real-World Outcomes () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_1202;    
    While earlier administration demonstrated a lower incidence of severe neutropenia, key efficacy metrics remained similar across early versus late introduction of CAR-T. Importantly, additional follow-up is needed to determine whether the benefit of earlier exposure to CAR-T endures over time.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Site-Specific Response Rates in Large B-Cell Lymphomas Treated with CD19-CART Therapy. () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_952;    
    This first-in-kind, large-scale analysis of site-specific dynamics in CAR-T patients identified lower response rates in the hepatobiliary/pancreatic, adrenal/kidney, and central nervous system organs. These findings suggest that pre- and post-CAR-T interventions may be optimized based on organ involvement.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Clinical Factors Associated with Failure to Manufacture Commercial CAR-T Cell Products Among LBCL Patients () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_948;    
    Conclusions Factors at apheresis predictive of manufacturing failure include poor PS, elevated LDH, CRP, ferritin and reduced ALC, AMC, HGB and PLT counts. Further studies are needed to better prospectively identify factors contributing to MF and stratify pts who may benefit from alternative treatment strategies.
  • ||||||||||  Actemra IV (tocilizumab) / Roche, JW Pharma
    Impact of Tocilizumab on CAR-T Cells Outcome and Toxicity: Results from a Large B Cell Lymphoma Cohort () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_947;    
    However, the incidence of prolonged neutropenia was associated with the number of toci doses received. The clinical need to use multiple doses of toci likely reflects an underlying CAR T and disease-associated inflammatory pathophysiology, ultimately leading to prolonged cytopenias in some patients.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Immunophenotypic CAR-T Cells Heterogeneity of Pre- and Post-Infusion of Tisagenlecleucel in Pediatric Patients with BCP-ALL. () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_936;    
    After infusion, phenotypic subsets within the CAR-positive T cell compartment changed dramatically, with no detectable of CAR+ Treg cells, a significant decrease of CAR+ CD4 cells, and an increase of CD8 cells within one to four weeks from treatment. Observed heterogeneity of CAR+ T cell subpopulations should be further studied in the context of clinical response and toxicity.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Durable Efficacy and Manageable Safety in Patients Age ?75 Years with Relapsed/Refractory Large B-Cell Lymphoma Treated with Tisagenlecleucel in the Real-World Setting () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_913;    
    Overall, these findings demonstrate that tisagenlecleucel could be considered a potential treatment option for pts with RT who have a high unmet medical need. Tisagenlecleucel demonstrated similar efficacy and rates of CRS and ICANS in pts with r/r LBCL age ?75 y as vs age <75 y. As few pts with r/r LBCL age ?75 y received CAR-T cell therapy in clinical trials, real-world evidence for this age group is invaluable for guiding treatment decisions in this clinical setting, and supports consideration of tisagenlecleucel, a therapy that results in durable disease control in approximately one quarter of pts with a low risk of severe toxicity.
  • ||||||||||  Characterization of Infectious Complications during the Expected Duration of Cytokine Release Syndrome (CRS) in Patients Receiving CAR T Cell Therapy  () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_905;    
    We retrospectively reviewed 191 patients treated with autologous CAR T cell products (idecabtagene vicleucel, ciltacabtagene autoleucel, tisagenlecleucel, axicabtagene ciloleucel, brexucabtagene autoleucel, lisocabtagene maraleucel) at Mount Sinai Hospital from April 2017 until February 2023...Levofloxacin as prophylaxis was given to 35% (60/170). These results suggest that judicious use of broad-spectrum antibiotics and limited infectious workup may be considered in clinically stable and non-neutropenic patients with CRS occurring during the pre-specified period post CAR T cell infusion.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    T-Cell Large Granular Lymphocyte Population Involving Chimeric Antigen Receptor-Modified T (CAR T) Cells in Patients with Cytopenia after CD19-Targeted CAR T-Cell Therapy: Case Series () -  Dec 11, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_897;    
    A 52-year-old (y/o) female (F) with R/R primary mediastinal B-cell lymphoma with central nervous system (CNS) involvement was treated with out-of-specification tisagenlecleucel...A 62 y/o F with R/R diffuse LBCL (DLBCL), NOS and chronic hepatitis B was treated with axicabtagene ciloleucel...A 50 y/o F, with R/R DLBCL, NOS with CNS involvement and history of cold agglutinin disease was treated with lisocabtagene maraleucel...In two of the patients, a subset of the clonal population expressed the CAR transgene. This case series highlights T-LGL as a potential cause of PC after CAR-T therapy.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Review, Journal, CAR T-Cell Therapy:  Chimeric antigen receptor T-cell therapy. (Pubmed Central) -  Dec 6, 2023   
    There are early promising results with chimeric antigen receptor T-cell therapies in other cancers. These include mantle cell lymphoma, multiple myeloma and some solid organ tumours such as glioblastoma multiforme.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Tecartus (brexucabtagene autoleucel) / Gilead
    Real World Outcomes for AYA Patients with Relapsed/Refractory B-Cell ALL Receiving CD19-Directed CAR T-Cell Therapy (Stars at Night B2 & B3 (Ballroom Level, Henry B. Gonzalez Convention Center); in-person) -  Dec 5, 2023 - Abstract #TCTASTCTCIBMTR2024TCT_ASTCT_CIBMTR_697;    
    No significant differences in 12mo OS or PFS were noted between products, though limited by small sample size. Results suggest more durable remission with brexu-cel, yet increased toxicity.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Trial completion date:  Study of Out of Specification for Tisagenlecleucel (clinicaltrials.gov) -  Dec 5, 2023   
    P3,  N=200, Recruiting, 
    Results suggest more durable remission with brexu-cel, yet increased toxicity. Trial completion date: Dec 2023 --> Apr 2024
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Biomarker, Journal:  The CD4/CD8 ratio of infused CD19-CAR-T is a prognostic factor for efficacy and toxicity. (Pubmed Central) -  Nov 15, 2023   
    The prognostic role of the CAR+CD4 /CD8 ratio was independent of the costimulatory domain (CD28 vs. 4-1BB) of the product (OR 16.41, p?=?0.041). Our data indicate a crucial role for CD8 CAR-T and the CAR+CD4 /CD8 ratio in predicting CAR-T efficacy.