P2, N=22, Recruiting, Tianjin Medical University Cancer Institute and Hospital | Not yet recruiting --> Recruiting | Initiation date: Sep 2024 --> May 2025

Between October 2021 and July 2023, 24 patients aged 41 to 88 years (median, 73.4 years) who had undergone prior therapies, including intensive chemotherapy (79.2%) and mogamulizumab immunotherapy (79.2%), received tucidinostat. Treatment-related adverse events were mainly hematologic but were managed over the course of treatment. Our findings indicate that tucidinostat provides survival benefits in patients with relapsed/refractory ATL in clinical practice and highlight key clinical factors for better outcomes.

P1/2, N=7, Terminated, Great Novel Therapeutics Biotech & Medicals Corporation | N=46 --> 7 | Trial completion date: Jan 2026 --> Jan 2025 | Recruiting --> Terminated; The overall profile does not support development for Hepatocellular Carcinoma

P1/2, N=44, Completed, The Netherlands Cancer Institute | Active, not recruiting --> Completed

P=N/A, N=200, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P2, N=130, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P2, N=10, Completed, Medibiofarma S.L. | Recruiting --> Completed | Trial completion date: Apr 2025 --> Dec 2024

P1/2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Jul 2025 --> Feb 2026

Compound 55 demonstrated good antitumor activity in vivo. Specifically, compound 55 combined with chidamide demonstrated a superior therapeutic effect over the first-line therapy RTX-CHOP in both the DEL and TP53 mutant DLBCL PDX tumor models.

P2, N=21, Active, not recruiting, The First Affiliated Hospital of Soochow University | Trial completion date: Aug 2025 --> Aug 2027 | Trial primary completion date: Dec 2024 --> Dec 2026

P2, N=33, Recruiting, The First Affiliated Hospital of Xiamen University | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2026

P=N/A, N=400, Recruiting, Ruijin Hospital | Not yet recruiting --> Recruiting

P2, N=33, Recruiting, The First Affiliated Hospital of Xiamen University | Trial completion date: Dec 2025 --> Dec 2027 | Trial primary completion date: Dec 2024 --> Dec 2027

P2, N=30, Recruiting, Shanghai Jiao Tong University School of Medicine | Trial primary completion date: Jan 2025 --> Jan 2026

This study not only elucidates the biological function of lactylated METTL3 in tumor cells but also highlights its negative regulatory effect on cisplatin resistance. Additionally, it underscores the nonclassical functional mechanism of Tucidinostat as a HDAC inhibitor for improving the efficacy of cisplatin against TNBC.

Here, by screening a library of marketed drugs, we identified Chidamide had a strong binding affinity toward VISTA (KD = 5 nM) and blocked VISTA/PSGL-1 under acidic conditions, thereby significantly enhancing the function of CD8+ T cells and inhibiting the tumor growth in immunocompetent murine CT26 tumor model. This study represents the first discovery of Chidamide as VISTA/PSGL-1 blocker for cancer immunotherapy.

P2, N=120, Recruiting, Chengdu Zenitar Biomedical Technology Co., Ltd | N=30 --> 120 | Trial completion date: May 2025 --> Dec 2025 | Trial primary completion date: Oct 2024 --> Oct 2025

We demonstrated that HDAC inhibitors (Entinostat and Vorinostat) sensitize AML cells to ferroptosis both in vitro and in vivo. Our results suggest a novel therapeutic approach for AML, where combining HDAC inhibitors with ferroptosis inducers could exploit the disrupted iron metabolism in AML cells. This study highlights the potential of HDAC inhibitors to modulate iron metabolism pathways, offering new insights into the treatment of these malignancies.

Co-treatment with an FAO inhibitor etomoxir enhanced the combined effects of chidamide with established chemotherapy drugs, as well as their efficacy as single agents in TNBC cells. In conclusion, FAO likely exerts pleiotropic biological effects in TNBC and modulating FAO may offer a promising strategy to improve therapeutic outcomes in TNBC.

Following two VCA courses, he received chimeric antigen receptor T-cell therapy, which led to complete metabolic remission and improved prognosis. This case underscores the potential of the VCA regimen as a bridging therapy for EMR in B-ALL with MLL-AF4, although further studies are warranted.

P2, N=17, The First Affiliated Hospital of Soochow University; The First Affiliated Hospital of Soochow University | N=30 --> 17

Our findings establish the profound upregulation of the EGFR/AREG axis by entinostat as starting point for a rational combination therapy in gastric carcinoma.

In vivo experiments showed that infusion of CD19 CAR T cells after chidamide bridging intervention can enhance the therapeutic effect of B-NHL and prolong the overall survival of mice. This study provides a new direction and theoretical foundation for CD19 CAR T cell therapy in B-NHL.

P=N/A, N=54, Affiliated Hospital of Guangdong Medical University; Affiliated Hospital of Guangdong Medical University

P2, N=32, Fudan University Shanghai Cancer Center Urology; Fudan University Shanghai Cancer Center Urology

Inspired by intestine colonizing bacterium, we developed a mucoadhesive probiotic Akkermansia muciniphila-mimic entinostat-loaded hollow mesopores prussian blue (HMPB) nanotherapeutic (AM@HMPB@E) for UC-targeted therapy via repairing intestinal barrier and scavenging RONS. Both in vitro and in vivo results shown that AM@HMPB@E not only exhibited an exceptional retention in the colitis site but also demonstrated superior therapeutic efficacy compared to the first-line drug sulfasalazine, as evidenced by the longer colon, less rectal bleeding and body weight loss. Collectively, our findings highlight the clinical application prospects of this synchronous nanotherapeutic strategy for UC treatment, offering a paradigm for the rational design of oral nanomedicine.

P=N/A, N=400, Not yet recruiting, Ruijin Hospital

To explore this further, A549 NSCLC cells were treated with various combinations of pemetrexed and the HDACi MS275 (Entinostat), and subsequently assessed for cell viability, cell cycle changes, and genotoxic markers. HDAC inhibition apparently exacerbates cytotoxicity of these agents by inhibiting error-free repair of misincorporated ribonucleotides in DNA. The potential of HDACis to modulate pyrimidine metabolism and DNA damage responses offers novel strategies for improving NSCLC outcomes.

P2, N=30, Recruiting, First Affiliated Hospital of Ningbo University

P1/2, N=45, Not yet recruiting, Peking University Cancer Hospital & Institute

P2, N=50, Recruiting, First Affiliated Hospital of Ningbo University

P2, N=37, Recruiting, Institute of Hematology & Blood Diseases Hospital, China | Trial primary completion date: Mar 2026 --> Dec 2026

Lastly, our experimental validation demonstrated the ability of the histone deacetylase (HDAC) inhibitor chidamide to activate the PPAR signal in TNBC cells. In conclusion, the PPAR signaling pathway likely has pleiotropic biological effects in TNBC. These preliminary but interesting findings enhance our understanding of the role played by PPAR signal and provide new insights into the heterogeneity driven by it in TNBC.

P2, N=34, Not yet recruiting, Ruijin Hospital

P2, N=63, Not yet recruiting, Peking University

P1, N=9, Terminated, Taipei Medical University Shuang Ho Hospital | Trial completion date: Dec 2024 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Mar 2024; The overall profile does not support development for metastatic colorectal cancer

The TRG-based risk model could predict HCC patient prognosis and closely linked to tumor immune environment, which could offer new possibilities for clinical treatment.

Concomitantly, cells with high basal or treatment-induced HER2 expression showed most profound sensitivities towards HDACi. These findings may thus provide the basis for HDACi treatment as a therapeutic option (1) particularly valuable in HER2-amplified gastric cancer and (2) particularly useful in combination therapies with HER2 inhibitors.

Notably, genes commonly mutated in AITL, including RHOA, TET2, DNMT3A, and IDH2, were absent in this case. A review of the literature highlights the heterogeneous genomic landscape of AITL and the diversity of treatment options available, underscoring the importance of tailored approaches to overcome resistance and improve outcomes in this distinct lymphoma subtype.

P3, N=423, Active, not recruiting, Chipscreen Biosciences, Ltd. | Trial completion date: Mar 2025 --> Jun 2025

P2, N=45, Active, not recruiting, Sun Yat-sen University | Recruiting --> Active, not recruiting | Trial completion date: Sep 2023 --> Oct 2025 | Trial primary completion date: Sep 2022 --> Aug 2024

P1/2, N=89, Completed, Syndax Pharmaceuticals | Phase classification: P1b --> P1/2