University of Pennsylvania 
Welcome,         Profile    Billing    Logout  
 27 Products   14 Diseases   27 Products   39 Trials   6077 News 


«12345678910111213...6667»
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Journal:  Evolving Evidence-Based Value Assessment of One-Time Therapies: Tisagenlecleucel as a Case Study. (Pubmed Central) -  Aug 21, 2024   
    Projections at launch of the likely cost effectiveness of tisagenlecleucel appear to have underestimated its ultimate economic value given more recent trial and real-world data. To balance uncertainty in initial valuation with the need to provide access to novel oncology therapies, payers can consider flexible reimbursement policies alongside ongoing assessments as new data emerge.
  • ||||||||||  CAR T-Cell Therapy-Induced Pseudomembranous Colitis Mimicking C. difficile Infection (Exhibit Hall E) -  Aug 20, 2024 - Abstract #ACG2024ACG_758;    
    Only two prior cases of colitis after CAR T have been reported, both presenting with diarrhea like this case but differing in endoscopic findings and implicated CAR T agents (tisagenlecleucel and axicabtagene ciloleucel)...This marks the 3 rd reported case of CAR T-associated colitis, the 1 st linked to ciltacabtagene autoleucel, and highlights the importance of considering CAR T in the differential diagnosis for diarrhea...Figure: Figure A: Colonoscopy findings showing erythematous and pseudomembrane-covered mucosa in the transverse colon. Figure B: Histopathological examination of transverse colon mucosal biopsy (photomicrograph at 20x magnification, H&E stain) showing colonic mucosa with a focal area of ballooned crypts lacking.
  • ||||||||||  SynKIR-110 / Verismo Therap
    Trial completion date, Trial primary completion date, Metastases:  SynKIR-110 for Mesothelin Expressing Ovarian Cancer, Cholangiocarcinoma or Mesothelioma (clinicaltrials.gov) -  Aug 19, 2024   
    P1,  N=42, Recruiting, 
    Figure B: Histopathological examination of transverse colon mucosal biopsy (photomicrograph at 20x magnification, H&E stain) showing colonic mucosa with a focal area of ballooned crypts lacking. Trial completion date: Mar 2026 --> Dec 2027 | Trial primary completion date: Mar 2026 --> Dec 2027
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Blincyto (blinatumomab) / Astellas, Amgen, Besponsa (inotuzumab ozogamicin) / Pfizer, UCB
    Review, Journal:  MRD in Philadelphia Chromosome-Positive ALL: Methodologies and Clinical Implications. (Pubmed Central) -  Aug 10, 2024   
    The presence of MRD has become an important predictive measure in Ph?+?ALL. Current studies evaluate the use of MRD in treatment decisions, especially in expanding therapeutic options for Ph?+?ALL, including tyrosine kinase inhibitors, targeted antibody therapies, chimeric antigen receptor cell therapy, and HCT.
  • ||||||||||  aDC1 vaccine / Roswell Park, University of Pittsburgh
    Enrollment open, Metastases:  Intensive Locoregional Chemoimmunotherapy for Recurrent Ovarian Cancer Plus Intranodal DC Vaccines (clinicaltrials.gov) -  Aug 9, 2024   
    P1/2,  N=25, Recruiting, 
    Current studies evaluate the use of MRD in treatment decisions, especially in expanding therapeutic options for Ph?+?ALL, including tyrosine kinase inhibitors, targeted antibody therapies, chimeric antigen receptor cell therapy, and HCT. Suspended --> Recruiting
  • ||||||||||  CART123 / University of Pennsylvania
    Enrollment closed, Enrollment change, Trial primary completion date:  Lentivirally Redirected CD123 Autologous T Cells in AML (clinicaltrials.gov) -  Aug 5, 2024   
    P1,  N=22, Active, not recruiting, 
    This is reflected by the kinetics of the chimeric antigen receptor T-cells during these treatments. Recruiting --> Active, not recruiting | N=12 --> 22 | Trial primary completion date: Aug 2024 --> Dec 2033
  • ||||||||||  Review, Journal, HEOR, CAR T-Cell Therapy:  Economic Evaluations of CAR-T Cell Therapies for Hematologic and Solid Malignancies: A Systematic Review. (Pubmed Central) -  Aug 4, 2024   
    CAR-T therapies were more expensive and generated more QALYs than comparators, but their cost-effectiveness was uncertain and dependent on patient population, cancer type, and model assumptions. This highlights the need for more nuanced economic evaluations and continued research to better understand the value of CAR-T therapies in diverse patient populations.
  • ||||||||||  TmMSTN-01 / Gilead
    Trial completion, Trial completion date, Trial primary completion date, CAR T-Cell Therapy:  CAR T Cells in Mesothelin Expressing Cancers (clinicaltrials.gov) -  Aug 2, 2024   
    P1,  N=54, Completed, 
    CAR-T cell therapy, as a second-line treatment, appears to be effective in achieving higher response rates and delaying the disease progression compared to SOC in R/R DLBCL. Active, not recruiting --> Completed | Trial completion date: Mar 2025 --> Jul 2024 | Trial primary completion date: Mar 2025 --> Nov 2023
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Enrollment closed, Minimal residual disease:  CASSIOPEIA: Study of Efficacy and Safety of Tisagenlecleucel in HR B-ALL EOC MRD Positive Patients (clinicaltrials.gov) -  Jul 25, 2024   
    P2,  N=121, Active, not recruiting, 
    All of the analyzed biomarkers rose within 14 days after CAR-T infusion, with most reaching their maximum around the third day following the procedure. Recruiting --> Active, not recruiting
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Journal:  Optimizing the Post-CAR T Monitoring Period for Axicabtagene Ciloleucel, Tisagenlecleucel, and Lisocabtagene Maraleucel. (Pubmed Central) -  Jul 23, 2024   
    NRM is driven by ICANS in the early follow-up period (1.1% until day 28), then by infection through three months post-infusion (1.2%). This study provides valuable insights into optimizing CAR T therapy monitoring and our findings may provide a framework to reduce physical and financial constraints for patients.
  • ||||||||||  FDA event, Review, Journal, CAR T-Cell Therapy:  FDA-approved CAR T-cell Therapy: A Decade of Progress and Challenges. (Pubmed Central) -  Jul 22, 2024   
    The data show that the average cost received by hospitals encompasses the expenses related to both the CAR T drug and the medical services delivered to patients. The CAR T-cell products highlighted in this review are FDA-approved products, which include Kymriah
  • ||||||||||  aDC1 vaccine / Roswell Park, University of Pittsburgh
    Journal:  Effects of Injectable Solutions on the Quality of Monocyte-Derived Dendritic Cells for Immunotherapy. (Pubmed Central) -  Jul 4, 2024   
    Alpha-type-1-polarized dendritic cells (aDC1s) have been shown to induce type-1 immunity with a high capacity to produce interleukin-12p70 (IL-12p70)...Cellular morphology was observed by electron microscopy, and the production of IL-12p70 by aDC1s was evaluated by ELISA. Compared with normal saline, Ringer's lactate solution was more effective at maintaining DC viability for up to 8?hr of incubation at 4 or 22
  • ||||||||||  AZD8076 / AstraZeneca, Inovio, AZD5396 / Inovio, AstraZeneca
    Enrollment closed:  dMAbs for Prevention of COVID-19 (clinicaltrials.gov) -  Jul 3, 2024   
    P1,  N=61, Active, not recruiting, 
    Compared with normal saline, Ringer's lactate solution was more effective at maintaining DC viability for up to 8?hr of incubation at 4 or 22 Recruiting --> Active, not recruiting
  • ||||||||||  Review, Journal, CAR T-Cell Therapy:  The treatment of follicular lymphoma with CD19-directed chimeric antigen receptor T-cell therapy. (Pubmed Central) -  Jun 21, 2024   
    New treatments with high ORR and durable PFS are needed in this setting, particularly in patients that progress within 2 years of first line chemoimmunotherapy (POD24) and/or those refractory chemoimmunotherapy. Chimeric antigen receptor T-cell therapies targeting the B-cell antigen CD-19 have shown to be an efficacious treatment option for both heavily pretreated patients and/or patients with refractory FL, resulting in a high ORR and durable remissions.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Journal, CAR T-Cell Therapy:  Severe anaphylaxis after chimeric antigen receptor T-cell injection: a case report. (Pubmed Central) -  Jun 19, 2024   
    We report the case of patient with severe anaphylaxis with cardiac arrest after tisagenlecleucel injection for Diffuse Large B cell Lymphoma, who recovered after resuscitation and intensive care treatment; we also conducted a Food and Drug Administration Adverse Event Reporting System database analysis and found several cases of severe anaphlyaxis after CAR-T cell injection. Although not reported in pivotal CAR-T cell studies, anaphylaxis can occur after CAR-T cell injection, highlighting the need to include anaphylaxis as a possible side effect in future studies.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Enrollment open, CAR T-Cell Therapy:  LOKI: Optimizing Lymphodepletion to Improve Outcomes in Patients Receiving Cell Therapy With Kymriah (clinicaltrials.gov) -  Jun 18, 2024   
    P1,  N=40, Recruiting, 
    Although not reported in pivotal CAR-T cell studies, anaphylaxis can occur after CAR-T cell injection, highlighting the need to include anaphylaxis as a possible side effect in future studies. Not yet recruiting --> Recruiting
  • ||||||||||  CART123 / University of Pennsylvania
    Enrollment open, Enrollment change:  CD123 Redirected T Cells for AML in Pediatric Subjects (clinicaltrials.gov) -  Jun 16, 2024   
    P1,  N=18, Recruiting, 
    Not yet recruiting --> Recruiting Active, not recruiting --> Recruiting | N=12 --> 18
  • ||||||||||  Cometriq (cabozantinib capsule) / Exelixis, Ipsen, Cabometyx (cabozantinib tablet) / Exelixis
    Phase classification, Combination therapy:  Autologous Dendritic Cell Vaccine in Kidney Cancer (clinicaltrials.gov) -  Jun 13, 2024   
    P2,  N=42, Recruiting, 
    Active, not recruiting --> Recruiting | N=12 --> 18 Phase classification: P2a --> P2
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Journal, CAR T-Cell Therapy, IO biomarker:  CAR+ extracellular vesicles predict ICANS in patients with B cell lymphomas treated with CD19-directed CAR T cells. (Pubmed Central) -  Jun 4, 2024   
    P=N/A
    Mosunetuzumab is estimated to be cost-effective compared with approved regimens except R-Len for the treatment of adults with R/R FL. These results convey that plasma CAR+EVs are an immediate signal of CD19.CAR-T cell activation, are suitable predictors of neurotoxicity, and may be involved in ICANS pathogenesis.
  • ||||||||||  Review, Journal:  The Implementation of Chimeric Antigen Receptor (CAR) T-cell Therapy in Pediatric Patients: Where Did We Come From, Where Are We Now, and Where are We Going? (Pubmed Central) -  May 31, 2024   
    By comparison, only a single CAR-T cell therapy is approved by the FDA for pediatric patients: tisagenlecleucel, which is approved for patients ? 25 years with refractory B-cell precursor ALL, or B-cell ALL in second or later relapse...All the other FDA-approved CD19-directed CAR-T cell therapies available for adult patients (axicabtagene ciloleucel, brexucabtagene autoleucel, and lisocabtagene maraleucel) are currently under investigations among children, with preliminary results available in some cases...This is particularly true when considering "atypical" situations, e.g.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Retrospective data, Review, Journal, CAR T-Cell Therapy:  Safety and Toxicity Profiles of CAR T Cell Therapy in Non-Hodgkin Lymphoma: A Systematic Review and Meta-Analysis. (Pubmed Central) -  May 30, 2024   
    Overall, this study serves as the first to delineate toxicity profiles associated with various available CAR T products. By better understanding associated toxicities, it may become possible to tailor therapies towards individual patients and anticipate the development of toxicities at earlier stages.
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    Retrospective data, Review, Journal, CAR T-Cell Therapy:  Network meta-analysis of CAR T-Cell therapy for the treatment of 3L+ R/R LBCL after using published comparative studies. (Pubmed Central) -  May 27, 2024   
    We highlight important differences in clinical outcomes between CAR T-cell therapies. Axi-cel demonstrated improved overall survival compared to tisa-cel and liso-cel, and both axi-cel and liso-cel showed higher response rates compared to tisa-cel.
  • ||||||||||  huCART19 / Novartis
    Enrollment open:  CAR-T Cell Therapy for Desensitization in Kidney Transplantation (clinicaltrials.gov) -  May 22, 2024   
    P1,  N=20, Recruiting, 
    Not yet recruiting --> Recruiting Not yet recruiting --> Recruiting
  • ||||||||||  Journal, Combination therapy:  Research Progress in the Use of Small Molecule Smac Mimetics in Combination Therapy of Cancer. (Pubmed Central) -  May 20, 2024   
    According to the phase II clinical data, xevinapant has the potential to significantly enhance the standard therapy for patients with head and neck cancer, which is expected to be approved as an innovative therapy for cancer patients. Therefore, this paper briefly describes the mechanism of IAPs (AT-406, APG-1387, GDC- 0152, TL32711, and LCL161) as single or in combination for cancer treatment, their application status as well as the synthetic pathway, and explores the research prospects and challenges of IAPs antagonists in the tumor combination therapy, with the hope of providing strong insights into the further development of Smac mimics in tumor therapy.
  • ||||||||||  Kymriah (tisagenlecleucel-T) / Novartis
    Journal, CAR T-Cell Therapy:  The challenge of standardizing CAR-T cell monitoring: A comparison of two flow-cytometry methods and correlation with qPCR technique. (Pubmed Central) -  May 17, 2024   
    Therefore, this paper briefly describes the mechanism of IAPs (AT-406, APG-1387, GDC- 0152, TL32711, and LCL161) as single or in combination for cancer treatment, their application status as well as the synthetic pathway, and explores the research prospects and challenges of IAPs antagonists in the tumor combination therapy, with the hope of providing strong insights into the further development of Smac mimics in tumor therapy. CAR-T cells were detected by two different flow-cytometry protocols (A and B) in nine blood samples from one healthy donor and five B-ALL patients treated with Tisagenlecleucel (Kymriah
  • ||||||||||  Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead
    EARLY AND LATE INTRODUCTION OF CAR T-CELL THERAPY IN LARGE B-CELL LYMPHOMA HAVE COMPARABLE TOXICITY AND EFFICACY OUTCOMES (Poster Area (Hall 7)) -  May 15, 2024 - Abstract #EHA2024EHA_3921;    
    Despite earlier administration, CAR-T therapy in LBCL exhibits toxicity and efficacy comparable to later-lineapproaches, suggesting an intrinsic resistance in some patients. This underscores the need for improvedbiomarkers to guide individualized treatment decisions.