itacitinib (INCB039110) / Incyte 
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 24 Diseases   17 Trials   17 Trials   546 News 


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  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial termination, Trial primary completion date:  Itacitinib for the Treatment of Bronchiolitis Obliterans Syndrome After Donor Hematopoietic Cell Transplant (clinicaltrials.gov) -  Nov 10, 2025   
    P1,  N=8, Terminated, 
    By preserving human-specific structural and functional features, our Trial completion date: May 2027 --> Oct 2025 | Active, not recruiting --> Terminated | Trial primary completion date: May 2027 --> Oct 2025; <75% participation
  • ||||||||||  T-prolymphocytic leukemia(T-PLL)  (Section 1 (Confex)) -  Nov 5, 2025 - Abstract #DGHO2025DGHO_847;    
    Valuable trial data teach us on the limited applicability of pre-clinical results, i.e. the limited efficacy of venetoclax+ibrutinib or of itacitinib + alemtuzumab.Overall, responses after induction therapy remain dissatisfactory as most patients relapse even after a CR following chemoimmunotherapy, which can only be consolidated in a fraction of allo-transplanted patients. Therefore, efficient implementation of new concepts in multi-center trial designs are urgently needed.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Phase classification:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Oct 16, 2025   
    P2,  N=31, Active, not recruiting, 
    These promisingpreliminary results warrant further comparative studies to confirm the efficacy and safety of anti-JAKinhibitor in this setting. Phase classification: P1 --> P2
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Enrollment closed:  Itacitinib With High-dose Posttransplantation Cyclophosphamide in Older Patients (clinicaltrials.gov) -  Sep 18, 2025   
    P1,  N=32, Active, not recruiting, 
    Trial completion date: May 2025 --> May 2027 | Trial primary completion date: May 2025 --> May 2027 Recruiting --> Active, not recruiting
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Journal:  Targeting synergetic endothelial inflammation by inhibiting NFKB and JAK-STAT pathways. (Pubmed Central) -  Sep 4, 2025   
    JAK1 inhibitor itacitinib blocked IFN?-, but not TNF?-induced proteomic responses...Imaging of Von Willebrand Factor (VWF) revealed an extracellular VWF network induced by combined stimulation, a phenotype which was reverted by both inhibitors. This study provides a preliminary basis for inhibiting endothelial inflammation in vascular inflammatory disorders.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) -  Aug 1, 2025   
    P2,  N=27, Recruiting, 
    This study provides a preliminary basis for inhibiting endothelial inflammation in vascular inflammatory disorders. Trial completion date: Jun 2026 --> Oct 2026 | Trial primary completion date: Jun 2025 --> Oct 2025
  • ||||||||||  dezapelisib (INCB040093) / Incyte
    Trial completion date, Trial primary completion date:  Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) -  Jun 3, 2025   
    P1,  N=121, Active, not recruiting, 
    No unexpected safety signals were observed. Trial completion date: Apr 2025 --> Apr 2026 | Trial primary completion date: Apr 2025 --> Apr 2026
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Journal:  Wheat germ agglutinin-nanoparticles encapsulating itacitinib target and suppress pro-inflammatory slan+ monocytes. (Pubmed Central) -  Apr 28, 2025   
    Findings support WGA/F127/PNPs as a promising drug delivery system for targeting slan+ monocytes, providing new therapeutic potential for SLE. ITA-loaded WGA/F127/PNPs effectively target and suppress pro-inflammatory slan+ monocytes, presenting a promising, cell-specific therapeutic approach for managing systemic lupus erythematosus and related autoimmune disorders.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    A pilot study of Janus kinase 1 (JAK1) inhibitor itacitinib for treatment-refractory sarcomas: Leiomyosarcoma cohort. (Hall A - Posters and Exhibits; Poster Bd #: 29) -  Apr 23, 2025 - Abstract #ASCO2025ASCO_2048;    
    P1
    Itacitinib demonstrated durable disease control in patients with LMS and warrants further study in this subtype. While our analysis of markers on paired biopsy samples does not suggest that immunotherapy combinations with itacitinib are likely to be successful for LMS, a more thorough analysis will be presented at the meeting as this data may still suggest potent combination therapies.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib for the Prevention of Graft Versus Host Disease (clinicaltrials.gov) -  Apr 8, 2025   
    P1,  N=31, Active, not recruiting, 
    While our analysis of markers on paired biopsy samples does not suggest that immunotherapy combinations with itacitinib are likely to be successful for LMS, a more thorough analysis will be presented at the meeting as this data may still suggest potent combination therapies. Trial completion date: Apr 2025 --> Apr 2027 | Trial primary completion date: Apr 2025 --> Apr 2027
  • ||||||||||  dezapelisib (INCB040093) / Incyte
    Trial completion date, Trial primary completion date:  Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) -  Feb 13, 2025   
    P1,  N=121, Active, not recruiting, 
    Trial completion date: Dec 2024 --> Jan 2026 Trial completion date: Jan 2025 --> Apr 2025 | Trial primary completion date: Jan 2025 --> Apr 2025
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Mechanism of CRS: Critical Roles of IFN-?, CD40L, and CD4 Cells. (HCC Ballroom B; In-Person) -  Dec 19, 2024 - Abstract #TCTASTCTCIBMTR2025TCT_ASTCT_CIBMTR_1334;    
    P1, P2
    Further, Lentiviral overexpression of CD40L in CD8 CART19 resulted in robust surface expression and secretion of CD40L as well as dramatic production of IL-6 by iDC (Data not shown). Together, our studies clearly implicate two major pathways that are necessary and sufficient for CRS: 1) IFN-?/IFN-?R/JAK1/2 axis (both CD4 and CD8) and 2) CD40L/CD40 PI3Kg/d axis (exclusively CD4) and represent logical targets for future CRS mitigation strategies in vivo .
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) -  Dec 13, 2024   
    P2,  N=27, Recruiting, 
    These encouraging results warrant further studies to evaluate the role of JAK inhibitors to prevent GVHD, replacing MMF. Trial completion date: Dec 2025 --> Apr 2026 | Trial primary completion date: Dec 2024 --> Apr 2025
  • ||||||||||  Hemophagocytic Syndrome Associated with CAR-T Cell Therapy () -  Dec 7, 2024 - Abstract #ASH2024ASH_9228;    
    on the use of drugs for cell therapy-related HLH at EBMT centers, common clinical combinations include corticosteroids + chemotherapy, corticosteroids + monoclonal antibodies + chemotherapy, corticosteroids + chemotherapy + cytokine blockade, corticosteroids + cytokine blockade, and corticosteroids alone. We introduce commonly used specific medications, including etoposide, emapalumab, the IL-six monoclonal antibody siltuximab, the anti-interleukin (IL)-six receptor monoclonal antibody tocilizumab, the interleukin-1 receptor antagonist anakinra, and JAK-one and JAK-two blockers such as ruxolitinib and the JAK-one inhibitor itacitinib, among others.
  • ||||||||||  Review, Journal:  Contemporary Updates in the Prevention and Treatment of Graft-Versus-Host Disease. (Pubmed Central) -  Nov 17, 2024   
    Combinations with novel agents such as itolizumab appear promising for high risk acute GVHD...For chronic GVHD requiring therapy beyond steroids, ruxolitinib, belumosudil, and ibrutinib are now available and should be considered. Increasingly, GVHD has become a manageable complication after allogeneic HCT potentially translating to greater success with allogeneic HCT in the future.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    P1 data, Journal, IO biomarker, Metastases:  Safety and efficacy of itacitinib, a selective JAK1 inhibitor, in advanced hepatocellular cancer: Phase 1b trial (JAKAL). (Pubmed Central) -  Nov 16, 2024   
    P1
    Tumor biopsies and blood samples will be taken for presence of JAK1 mutations.Activation of JAK/STAT pathway drives HCC development and is associated with immunotherapy resistance. Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov).
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial primary completion date:  Itacitinib + Everolimus in Hodgkin Lymphoma (clinicaltrials.gov) -  Nov 14, 2024   
    P1/2,  N=23, Active, not recruiting, 
    Itacitinib is hypothesized to be safe and effective in HCC patients that have progressed after first-line therapies.Clinical Trial Registration: EudraCT: 2017-004437-81 NCT04358185 (ClinicalTrials.gov). Trial primary completion date: Oct 2024 --> May 2024
  • ||||||||||  parsaclisib (INCB50465) / Incyte
    Enrollment closed, Enrollment change:  Rollover Study to Provide Continued Treatment for Participants With B-Cell Malignancies Previously Enrolled in Studies of Parsaclisib (INCB050465) (clinicaltrials.gov) -  Nov 1, 2024   
    P2,  N=112, Active, not recruiting, 
    The observed aGVHD rate was lower than our previously published historic data in patients receiving Tac/Siro alone (31% vs. 9%), half of the cases with grade 2-4 aGVHD were diagnosed after day +100 when itacitinib administration stopped per protocol therapy, indicating the need for further refinement in tapering strategy of Tac/Siro/itacitinib, potentially guided by the cytokine/cellular biomarkers identified in our study. Recruiting --> Active, not recruiting | N=200 --> 112
  • ||||||||||  dezapelisib (INCB040093) / Incyte
    Trial completion date, Trial primary completion date:  Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies (clinicaltrials.gov) -  Oct 22, 2024   
    P1,  N=121, Active, not recruiting, 
    Trial completion date: Sep 2024 --> Sep 2027 | Trial primary completion date: Sep 2024 --> Sep 2027 Trial completion date: Aug 2024 --> Jan 2025 | Trial primary completion date: Aug 2024 --> Jan 2025
  • ||||||||||  Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
    Trial completion, Trial completion date, Trial primary completion date:  NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (clinicaltrials.gov) -  Sep 26, 2024   
    P1,  N=15, Completed, 
    Trial completion date: May 2024 --> May 2025 | Trial primary completion date: May 2024 --> May 2025 Active, not recruiting --> Completed | Trial completion date: Dec 2026 --> Sep 2024 | Trial primary completion date: Dec 2026 --> Sep 2024
  • ||||||||||  Strategies to Mitigate CAR T-Cell-Associated Cytokine Release Syndrome and Neurologic Toxicity (Room A (2F)) -  Sep 24, 2024 - Abstract #ICBMT2024ICBMT_47;    
    I will spotlight promising data from a recent clinical trial investigating the JAK-1 inhibitor itacitinib to prevent CRS and ICANS after axi-cel treatment (Frigault et al., ASH Abstract...Lastly, I will share our experience with anakinra to prevent CRS and ICANS in patients with large B-cell lymphoma receiving the CD19 CAR T-cell product lisocabtagene maraleucel on an investigator-initiated clinical trial (Liang et al., Tandem Meeting Abstract...2023). Learning objectives: - Identify clinical and laboratory factors associated with severe CRS and ICANS - Recognize differences in the toxicity profile across distinct CAR T-cell products - Become acquainted with current toxicity prophylactic strategies
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date:  Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) -  Aug 26, 2024   
    P2,  N=27, Recruiting, 
    Learning objectives: - Identify clinical and laboratory factors associated with severe CRS and ICANS - Recognize differences in the toxicity profile across distinct CAR T-cell products - Become acquainted with current toxicity prophylactic strategies Trial completion date: Nov 2026 --> Dec 2025
  • ||||||||||  itacitinib (INCB039110) / Incyte, Keytruda (pembrolizumab) / Merck (MSD)
    Phase II Study of Pembrolizumab and Itacitinib for Patients with Metastatic NSCLC Expressing PD-L1: Long-Term Follow up (20BC) -  Jul 24, 2024 - Abstract #IASLCWCLC2024IASLC_WCLC_870;    
    P2
    Conclusions : Treatment-nai?ve pts with mNSCLC and PD-L1 expression ?50% treated with pembrolizumab and a brief course of JAK inhibition achieved an ORR of 62% at 12 weeks and improvement in mPFS and mOS compared to historical controls (Keynote 24: mPFS 10.3 mo, mOS 30 mo). Interferon signaling modulation through JAK1 inhibition may help prevent resistance to anti-PD1 therapy and should be studied further in a randomized trial.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Clinical Trial,Phase II, Journal:  Combined JAK inhibition and PD-1 immunotherapy for non-small cell lung cancer patients. (Pubmed Central) -  Jun 20, 2024   
    Patients with persistent inflammation refractory to itacitinib showed progressive CD8 T cell terminal differentiation and progressive disease. Thus, JAK inhibition may improve the efficacy of anti-PD-1 immunotherapy by pivoting T cell differentiation dynamics.
  • ||||||||||  itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  Itacitinib Pre-modulation in DLBCL Receiving CAR T Cell Therapy (clinicaltrials.gov) -  Jun 5, 2024   
    P2,  N=27, Recruiting, 
    Thus, JAK inhibition may improve the efficacy of anti-PD-1 immunotherapy by pivoting T cell differentiation dynamics. Trial completion date: May 2026 --> Nov 2026 | Trial primary completion date: Jun 2024 --> Oct 2024
  • ||||||||||  Campath (alemtuzumab) / Sanofi, itacitinib (INCB039110) / Incyte
    Trial completion date, Trial primary completion date:  NCI-2019-03203: Itacitinib and Alemtuzumab in Treating Patients With T-Cell Prolymphocytic Leukemia (clinicaltrials.gov) -  May 8, 2024   
    P1,  N=15, Active, not recruiting, 
    stimulation induced proteins in a single generic induction pattern over time whereas TNF?-induced proteins showed distinct grouping of Trial completion date: Dec 2023 --> Dec 2026 | Trial primary completion date: Dec 2023 --> Dec 2026