- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment closed, Trial primary completion date: JULIET: Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (clinicaltrials.gov) - Dec 13, 2019 P2, N=170, Active, not recruiting, Completed --> Terminated; Lack of efficacy and funding to continue investigation Recruiting --> Active, not recruiting | Trial primary completion date: Mar 2017 --> Feb 2023
- |||||||||| chimeric antigen receptor T cell therapeutics - MabVax, Memorial Sloan / Kettering Cancer Center
Medicare Patients Receiving Chimeric Antigen Receptor T-Cell Therapy for Non-Hodgkin Lymphoma: A Real-World Look at Patient Characteristics, Healthcare Utilization and Costs (World Center Marriott - Palms: Sabal) - Dec 8, 2019 - Abstract #TCTASTCTCIBMTR2020TCT_675; Objectives: To describe the demographic and clinical characteristics of Medicare pts receiving CAR T therapy (axicabtagene ciloleucel or tisagenlecleucel), and compare healthcare utilization, costs, and outcomes pre- and post-CAR T therapy. The results of this real-world study indicate that older pts with multiple comorbidities can be treated successfully with CAR T therapy, and that post-index care was associated with lower hospitalization rates, bed days, ED visits, and total costs.
- |||||||||| Actemra IV (tocilizumab) / Roche, JW Pharma
Comparing Car T Cells Toxicities Grading Systems: Application of Astct Grading System and Implications for Management (World Center Marriott - Cypress 3) - Dec 8, 2019 - Abstract #TCTASTCTCIBMTR2020TCT_663; P1 Methods We included 53 patients (pts) with B acute lymphoblastic leukemia (B-ALL) treated with 1928z CAR T cells (NCT01044069) and 49 pts with diffuse large B cell lymphoma (DLBCL) who received axicabtagene ciloleucel (axi-cel, n=36) or tisagenlecleucel (tisa-cel, n=13) after FDA approval...At our center 58% and 13% of patients with CRS received tocilizumab (toci) and steroids, respectively, similarly to what predicted according to axi-cels, CARTOX and NCCN guidelines, but differently from tisa-cels label (10% and 5%)...Conclusions Different grading systems provide inconsistent CRS/ICANS scores. To avoid discrepancies in assessing and managing toxicities of different products, a unified grading should be used and paired management guidelines with product-specific indications should be developed.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
Enrollment open, Enrollment change: JULIET: Study of Efficacy and Safety of CTL019 in Adult DLBCL Patients (clinicaltrials.gov) - Dec 6, 2019 P2, N=170, Recruiting, Ongoing analyses will evaluate CAR T cell expansion, duration of remission, and additional safety endpoints, including rates of neurotoxicity. Active, not recruiting --> Recruiting | N=115 --> 170
- |||||||||| birinapant (TL 32711) / Medivir, AT-406 / Debiopharm, Ascenta, alisertib (MLN8237) / Takeda
Review, Journal, IO Biomarker: Therapeutic Inducers of Apoptosis in Ovarian Cancer. (Pubmed Central) - Nov 29, 2019 Several drugs in our review are undergoing clinical trials, for example, birinapant, DEBIO-1143, Alisertib, and other small molecules are in preclinical investigations showing promising results in combination with chemotherapy. Molecules that exhibit better efficacy in the treatment of chemo-resistant cancer cells are of interest but require more extensive preclinical and clinical evaluation.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, melphalan / Generic mfg.
Journal, CAR T-Cell Therapy: Anti-CD19 CAR T cells with high-dose melphalan and autologous stem cell transplantation for refractory multiple myeloma. (Pubmed Central) - Nov 22, 2019 P1 From our data we conclude that XIAP acts as a multifunctional pro-metastatic protein in skin melanomas and, as a consequence, that XIAP may serve as a therapeutic target for these melanomas. CTL019 may improve duration of response to standard multiple myeloma therapies by targeting and precipitating secondary immune responses against myeloma-propagating cells.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis
FDA event, Journal: First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval. (Pubmed Central) - Nov 22, 2019 In August 2017, the U.S. Food and Drug Administration (FDA) took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Review, Journal, CAR T-Cell Therapy: Immunogenicity of Chimeric Antigen Receptor T-Cell Therapeutics. (Pubmed Central) - Nov 21, 2019 Both humoral (antibody-based) and cellular-type responses have been described, leading to various degrees of impact on CAR-T expansion and persistence, and therefore the overall safety and clinically meaningful response of the treatment. In this article we discuss various types of immune responses specific to CAR-T therapy, their impact on treatment outcome, and methodologies used to detect them.
- |||||||||| NN1213 / Novo Nordisk, aDC1 vaccine / Roswell Park, University of Pittsburgh
Enrollment closed, Enrollment change, Trial completion date, Metastases: Type I-Polarized Autologous Dendritic Cell Vaccine With Tumor Blood Vessel Antigen-Derived Peptides in Metastatic Breast Cancer Patients (clinicaltrials.gov) - Nov 20, 2019 P1, N=18, Active, not recruiting, In this article we discuss various types of immune responses specific to CAR-T therapy, their impact on treatment outcome, and methodologies used to detect them. Recruiting --> Active, not recruiting | N=30 --> 18 | Trial completion date: Oct 2019 --> Mar 2020
- |||||||||| birinapant (TL 32711) / Medivir, entinostat (SNDX-275) / Kyowa Hakko Kirin, Syndax
Journal: Cytoplasmic FLIP(S) and nuclear FLIP(L) mediate resistance of castrate-resistant prostate cancer to apoptosis induced by IAP antagonists. (Pubmed Central) - Nov 19, 2019 While the cytoplasmic pool of FLIP(L) was highly stable, the nuclear pool was more labile and regulated by the Class-I HDAC target Ku70, which we have previously shown regulates FLIP stability. The efficacy of IAP antagonist (TL32711) and Entinostat combination and their effects on cIAP1 and FLIP respectively were confirmed in vivo, highlighting the therapeutic potential for targeting IAPs and FLIP in proinflammatory CRPC.
- |||||||||| Breyanzi (lisocabtagene maraleucel) / BMS, Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Journal, CAR T-Cell Therapy: Chimeric Antigen Receptor T-Cell Therapies for Aggressive B-Cell Lymphomas: Current and Future State of the Art. (Pubmed Central) - Nov 19, 2019 Rational combination strategies with CAR T cells are under evaluation, including immune checkpoint inhibitors, immunomodulators, and tyrosine kinase inhibitors. Novel cell products are also being developed and include CAR T cells that target multiple tumor antigens, cytokine-secreting CAR T cells, and gene-edited CAR T cells, among others.
- |||||||||| Ad-RTS-hIL-12 / Alaunos Therap, veledimex (INXN-1001) / University of Pennsylvania
Enrollment closed: A Study of Ad-RTS-hIL-12 With Veledimex in Combination With Nivolumab in Subjects With Glioblastoma; a Substudy to ATI001-102 (clinicaltrials.gov) - Nov 19, 2019 P1, N=21, Active, not recruiting, Novel cell products are also being developed and include CAR T cells that target multiple tumor antigens, cytokine-secreting CAR T cells, and gene-edited CAR T cells, among others. Recruiting --> Active, not recruiting
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Review, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: CAR-T Cell Therapy in Diffuse Large B Cell Lymphoma: Hype and Hope. (Pubmed Central) - Nov 16, 2019 In this review, we summarize the results of 3 large phase II CD19 CAR-T cell trials and focus on AEs. We also provide a perspective of ongoing activity in this field with the intend to improve the potency of this emerging novel therapy.
- |||||||||| Kymriah (tisagenlecleucel-T) / Novartis, Yescarta (axicabtagene ciloleucel) / Gilead, Daiichi Sankyo
Review, Clinical Trial,Phase I, Clinical Trial,Phase II, Journal: CAR T Cell Toxicity: Current Management and Future Directions. (Pubmed Central) - Nov 16, 2019 Axicabtagene ciloleucel (Yescarta, Kite) is indicated for the treatment of adult patients with large B-cell lymphoma relapsed or refractory after 2 or more lines of systemic therapy, including DLBCL not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (ZUMA-1 trial). This review will offer a practical guide for the recognition and management of the most important toxicities related to the use of the current commercial CAR T cells, and also highlight strategies to diminish these side effects in the future.
- |||||||||| Trial completion date, Trial primary completion date: CD22 Redirected Autologous T Cells for ALL (clinicaltrials.gov) - Nov 15, 2019
P1, N=15, Recruiting, This review will offer a practical guide for the recognition and management of the most important toxicities related to the use of the current commercial CAR T cells, and also highlight strategies to diminish these side effects in the future. Trial completion date: Dec 2021 --> Dec 2022 | Trial primary completion date: Dec 2020 --> Dec 2021
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