A Randomized, Open-label, Phase 2 Trial of Chidamide+Decitabine Plus Anti-PD-1 Antibody in PD-1 Inhibitor Failed Patients With Classical Hodgkin Lymphoma.

The issue of therapy after PD-1 inhibitor failure is unresolved in classic Hodgkin lymphoma. Preliminary clinical observations have shown that patients might benefit from Chidamide+Decitabine plus anti-PD-1 antibody. This open-label, randomized, phase 2 study aims to evaluate the efficacy of Chidamide+Decitabine plus anti-PD-1 and the standard of care, which includes anti-PD-1 antibody, in patients with classical Hodgkin lymphoma who have experienced failure with PD-1 inhibitor. The primary objective of the study is to evaluate the 12-month progression-free survival rates.

Start Date01 Jun 2024

Sponsor / Collaborator

Chinese People's Liberation Army General Hospital

NCT06218888 / Not yet recruitingPhase 2IIT

A Phase II Clinical Study of the Efficacy and Safety of Tislelizumab Combined With Fruquintinib and Chidamide in the Treatment of Unresectable or Advanced Microsatellite Stabilized (MSS/pMMR) Colorectal Cancer With Liver Metastases

To explore the Efficacy and Safety of Tislelizumab combined with fruquintinib and Chidamide in the treatment of unresectable or advanced microsatellite stabilized (MSS/pMMR) colorectal cancer with liver metastases

Start Date01 Jun 2024

Sponsor / Collaborator

Fujian Cancer Hospital

NCT06451861 / Not yet recruitingPhase 2IIT

Randomized Study of ABC-14 Regimen ( AZA, Venetoclax and Chidamide) Compared With "3+7" Standard Induction Therapy or AB-14 (Venetoclax Combined With Azacitidine) for Newly Diagnosed Acute Myeloid Leukemia

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Start Date31 May 2024

Sponsor / Collaborator

Guangdong General Hospital

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

312

Literatures (Medical) associated with Chidamide

01 Jan 2024·BMJ case reports

Improving gastrointestinal quality of life: romidepsin to tucidinostat in a case of angioimmunoblastic T cell lymphoma

Article

Author: Kanaya, Shuhei ; Isoda, Atsushi ; Terasaki, Yukie ; Saito, Akio

Relapsed/refractory (R/R) peripheral T cell lymphoma (PTCL) has a poor prognosis, with limited treatment options and generally no durable response. However, long-term remission with the histone deacetylase (HDAC) inhibitor romidepsin has been reported, especially in angioimmunoblastic T cell lymphoma (AITL). Recently, tucidinostat, a novel oral HDAC inhibitor that selectively inhibits class I and class IIb HDACs, was approved for R/R PTCL in China and Japan. We present the case of a patient with AITL whose gastrointestinal symptoms and health-related quality of life improved after switching from romidepsin to tucidinostat as maintenance therapy. Romidepsin and tucidinostat appear to have different safety profiles; non-haematological toxicities such as nausea, vomiting, constipation, anorexia and fatigue may be reported less frequently with tucidinostat than with romidepsin. This case suggests that switching to tucidinostat therapy may be a viable option for patients with PTCL suffering from severe gastrointestinal adverse events with romidepsin.

01 Jan 2024·European journal of medicinal chemistry

Serendipitous discovery of Class I HDAC inhibitors from rational design of molecular glue degraders targeting HDAC

Article

Author: An, Jianxiong ; Gu, Zhicheng ; Chen, Di ; He, Bin ; Yan, Wanli ; Lin, Shuxian ; Zeng, Ziwei ; Chen, Lei

Zinc-dependent histone deacetylases (HDACs) play an essential role as epigenetic regulators and are becoming increasingly important drug targets for the treatment of cancer. Although five HDAC inhibitors have been approved for treating several cancers, only one of them is a Class I HDAC inhibitor, which may have advantages over pan-HDAC inhibitors due to the various side effects associated with the latter. On the other hand, the emerging strategy of molecular glue degraders offers a unique advantage for targeting therapeutic proteins. In this study, we synthesized a series of candidate compounds based on the molecule glue, pomalidomide, using a "merger principle", initially aiming to obtain molecular glue degraders that can target HDAC degradation. However, we serendipitously discovered that compounds 2f and 3f may be potent Class I HDAC selective inhibitors. After further evaluation, we found that compounds 2f and 3f exhibit selective inhibitory effects on Class I HDAC in cancer cells. Moreover, they showed the robust antiproliferative activities against various hematological tumor cells, comparable to that of the approved Class I HDAC inhibitor, Chidamide. These results suggest that pomalidomide-derivatized compounds have promising potential as Class I HDAC inhibitors with therapeutic applications in cancer treatment.

31 Dec 2023·Hematology (Amsterdam, Netherlands)

Application of prophylactic or pre-emptive therapy after allogeneic transplantation for high-risk patients with t(8;21) acute myeloid leukemia

Article

Author: Yang, Donglin ; Zhang, Rongli ; Liu, Xin ; Pang, Aiming ; He, Yi ; Jiang, Erlie ; Zhai, Weihua ; Cao, Yigeng ; Zheng, Yawei ; Feng, Sizhou ; Wang, Mingyang ; Guo, Wenwen ; Chen, Xin ; Ma, Qiaoling ; Wei, Jialin ; Liu, Jia ; Han, Mingzhe

OBJECTIVES:

To determine the impact of pretransplant measurable residual disease (pre-MRD) and the efficacy of maintenance therapy in t(8;21) acute myeloid leukemia (AML) patients after allogeneic hematopoietic cell transplantation (allo-HCT).

METHODS:

We retrospectively analyzed 100 t(8;21) AML patients who underwent allo-HCT between 2013 and 2022. 40 patients received pre-emptive therapy including immunosuppressant adjustment, azacitidine, and donor lymphocyte infusion (DLI) combined with chemotherapy. 23 patients received prophylactic therapy, including azacitidine or chidamide.

RESULTS:

Patients with a positive pre-MRD (pre-MRDpos) had a higher 3-year cumulative incidence of relapse (CIR) (25.90% [95% CI, 13.87%-39.70%] vs 5.00% [95% CI, 0.88%-15.01%]; P = 0.008). Pre-MRDpos patients were less likely to have a superior 3-year disease-free survival (DFS) (40.83% [95% CI, 20.80%-80.16%]) if their MRD was still positive at 28 days after transplantation (post-MRD₂₈pos). The 3-year DFS and CIR were 53.17% (95% CI, 38.31% - 73.80%) and 34.87% (95% CI, 18.84% - 51.44%), respectively, for patients receiving pre-emptive interventions after molecular relapse. The 3-year DFS and CIR were 90.00% (95%CI, 77.77% - 100%) and 5.00% (95%CI, 0.31% - 21.10%), respectively, for high-risk patients receiving prophylactic therapy. In most patients, epigenetic-drug-induced adverse events were reversible with dose adjustment or temporary discontinuation.

CONCLUSION:

Patients with pre-MRDpos and post-MRD₂₈pos were more likely to have higher rates of relapse and inferior DFS, even after receiving pre-emptive interventions. Prophylactic therapy may be a better option for high-risk t(8;21) AML patients; however, this warrants further investigation.

News (Medical) associated with Chidamide

30 Apr 2024

·www.prnewswire.com

National Medical Products Administration (NMPA) Approves Chipscreen Bioscience's Chidamide (Epidaza) combined with R-CHOP for the treatment of diffuse large B-cell lymphoma

SHENZHEN, China, April 30, 2024 /PRNewswire/ -- Shenzhen Chipscreen Biosciences Co., Ltd. (Chipscreen Biosciences, Stock Symbol: 688321.SH) announced that the company's lead innovative product Chidamide (Epidaza®) , an oral subtype-selective histone deacetylase (HDAC) inhibitor, combined with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone), has been officially approved by the National Medical Products Administration (NMPA) for treatment of previously untreated diffuse large B-cell lymphoma (DLBCL) with positive MYC and BCL2 expression. Up to now, Chidamide has been approved for multiple indications globally. (For more information, please review the global commercialization situation). Diffuse large B-cell lymphoma (DLBCL) is the most common type of lymphoma, with approximately 30000 new cases occurring annually in China. Clinical diagnosis and treatment guidelines and consensus both domestically and internationally recommend the R-CHOP regimen as the standard first-line treatment for DLBCL. However, about one-third or more of patients in the overall population still experience ineffective or early recurrence of first-line R-CHOP treatment. Meanwhile, approximately 30% of patients with DLBCL exhibit simultaneous overexpression of MYC/BCL2 protein (referred to as "double expression" lymphoma, DEL), and their efficacy and prognosis after R-CHOP treatment are significantly lower than those of non double expression patients. Therefore, how to combine new drugs based on R-CHOP regimen to provide a more effective and safer treatment to our patients is a significant unmet medical need. The approval of this new indication is based on a randomized, double-blind, placebo-controlled, multicenter Phase III clinical trial DEB trial (NCT04231448). The DEB trial is the first Phase III registered clinical study in the world as first line treatment of MYC/BCL2 dual expression diffuse large B-cell lymphoma. This trial is to evaluate the efficacy and safety of Chidamide combined with R-CHOP compared to R-CHOP in primary treatment and MYC/BCL2 dual expression DLBCL subjects. Based on the interim analysis conducted by the Independent Data Monitoring Committee (iDMC), the efficacy and safety indicators set by the protocol were achieved. Compared with the R-CHOP regimen, the Chidamide combination regimen significantly improved the complete response rate (CRR) of the study's key secondary endpoint, and the study's primary endpoint, event free survival (EFS), also showed a clear trend of benefit. The experimental safety profile is consistent with known risks, and no new significant safety signals were found. The results of the interim analysis of the DEB Phase III study were selected as the Late breaking Abstract (LBA) for the American Society of Clinical Oncology (ASCO) Annual Meeting on April 24, 2024. Dr. Xianping Lu, Chairman and General Manager of Chipscreen Biosciences, stated, "The classic R-CHOP regimen has been used as a first-line treatment for diffuse large B-cell lymphoma (DLBCL) for nearly 20 years, but its therapeutic effect is not satisfactory in populations with dual expression of BCL2 and MYC proteins. The combination of Chidamide and R-CHOP is the world's first phase 3 registered clinical study that focuses on first line therapy of dual expressed DLBCL, and also the world's first R-CHOP improvement study with significant benefits in complete remission rate. We believe that the approval of the new indication will bring new hope and better survival benefits to patients." About Chidamide (Epidaza®) Chidamide (Tucidinostat, Trade name: Epidaza®), a Class 1.1 innovative drug, is a novel molecular entity with global patent protection and the first marketed product developed independently by Chipscreen Biosciences. The first original chemical new drug approved in China, Chidamide is also the first oral subtype-selective histone deacetylase (HDAC) inhibitor in the world, Since its approval in China in December 2014 for the treatment of peripheral T-cell lymphoma, Chidamide has achieved significant commercialization worldwide and continuously explored new indications. Global commercialization situation: In December 2014, Chidamide was approved for use in patients with recurrent or refractory peripheral T-cell lymphoma (PTCL) in China; In November 2019, Chidamide was approved to combine aromatase inhibitors to treat locally advanced or metastatic breast cancer patients with estrogen receptor positive, human epidermal growth factor receptor-2 negative, postmenopausal, and endocrine therapy relapse or progress in China; In June 2021, Chidamide was approved for monotherapy in the treatment of recurrent or refractory (R/R) adult T-cell leukemia (ATL) in Japan; In December 2021, Chidamide was approved for monotherapy for recurrent or refractory (R/R) peripheral T-cell lymphoma (PTCL) in Japan; In March 2023, Chidamide was approved to be used for postmenopausal women with locally advanced or metastatic breast cancer who are hormone receptor positive, type II human epidermal growth factor receptor (HER2) negative, and relapse or worsen after endocrine therapy (in combination with exemestane) in Taiwan, China; In April 30, 2024, Chidamide was approved to use in combination with R-CHOP (rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone) for previously untreated diffuse large B-cell lymphoma (DLBCL) patients with positive MYC and BCL2 expression in China. Global exploration of other indications: In addition to ongoing global multicenter phase III clinical trial for the first-line treatment of melanoma in comniation with Opdivo, Chidamide is also conducting multiple clinical trials in China and internationally in combination with different anti-tumor immunotherapies. In November 2023, the Phase II clinical trial of the first-line treatment of non-small cell lung cancer with Chidamide combined with Tislelizumab was completed and enrolled. On March 4, 2024, Professor Ruihua Xu and Professor Feng Wang from the Cancer Prevention and Treatment Center of Sun Yat sen University led the research on CAPAbility-01, which was published on the world's top academic journal Nature Medicine (IF=82.9). As one of the most valuable sub journals under Nature, the publication of Nature Medicine reflects the academic authority's recognition of CAPAbility-01 research. This study indicates that for patients with microsatellite stable/mismatched repair function intact (MSS/pMMR) type metastatic colorectal cancer (mCRC), a three drug regimen led by Chidamide (Chidamide+sintilimab antibody+bevacizumab) for third line and above treatment, with an 18 week PFS rate of 64.0%, an ORR of 44.0%, and a median PFS of 7.3 months, is considered a promising treatment option for MSS/pMMR advanced CRC patients. On April 24, 2024, an abstract entitled "Tucidinostat plus R-CHOP in previously untreated diffuse large B-cell lymphoma with double expression of MYC and BCL2: An interim analysis from the phase III DEB study" was selected the American Society of Clinical Oncology (ASCO) LBA list for the 2024 ASCO, which submitted by Professor Weili Zhao's team from Ruijin Hospital affiliated with Shanghai Jiao Tong University School of Medicine About Chipscreen Chipscreen Biosciences is an innovative drug company driven by core technologies with globally competitive pipelines. As a pioneer in drug innovation & development in China, adhering to the concept of "Constant Innovation for Life", we focus on developing revolutionary innovative drugs with new mechanisms of action, to address patients' pressing clinical needs. Our complete industry chain that covers early exploratory discovery through commercialization allows us to provide innovative Chinese drugs for patients worldwide. With a global development strategy based on early-stage research in China, Chipscreen Biosciences has leveraged the top scientists and teams with extensive experience in related fields from the Shenzhen Small Molecule Early R&D Center and Chengdu Small Molecule Early R&D Center to create an integrated technology platform based on AI-driven design and chemical genomics, which spanned the whole process from basic science to clinical translation. We have successfully developed first-in-class and best-in-class innovative drugs. Currently, we have marketed two drugs for threeindications in Mainland China, two indications in Japan, and one indication in Taiwan, China. In addition, we have launched a number of R&D projects with differentiated advantages and global competitiveness in the five major areas, including malignant tumors, metabolic diseases, autoimmune diseases, central nervous system diseases, and antivirals. Chipscreen Biosciences has formed a global industrial layout consisting of Shenzhen Head Office/R&D Center/GMP production base, Chengdu Regional Head Office/R&D Center/GMP production base, Beijing Branch, Shanghai Branch, and Chipscreen Biosciences (USA) Co., Ltd. Meanwhile, as one of the first batches of national "innovative drug incubation bases" and national high-tech enterprises, Chipscreen Biosciences has independently undertaken many national "863" plans and national major science and technology projects, such as "10th five-year plan", "11th five-year plan", "12th five-year plan" and "13th five-year plan", and National Science and Technology primary Project for Innovative Drug Development. We have filed over 660 invention patents in China and worldwide, with over 180 granted. SOURCE Shenzhen Chipscreen Biosciences Co., Ltd.

Phase 3Drug ApprovalPhase 2Clinical ResultImmunotherapy

21 Mar 2024

·www.biospace.com

Muscular Dystrophy Association’s Funding of Foundational Research Leads to New FDA Approved Treatment Duvyzat (givinostat) for Duchenne Muscular Dystrophy

New York, March 21, 2024 (GLOBE NEWSWIRE) -- The Muscular Dystrophy Association’s funding of foundational research leads to new drug approval by the US Food and Drug Administration (FDA) of Duvyzat (givinostat), a histone deacetylase (HDAC) inhibitor to treat children and adolescents living with Duchenne muscular dystrophy (DMD). This drug changes gene expression in cells by altering the three-dimensional folding of DNA and has shown that it can slow DMD progression. Duvyzat (givinostat) will be made available in the United States by ITF Therapeutics. Results from a phase 3 clinical trial of Duvyzat (givinostat) recently published in The Lancet demonstrated a significantly smaller decline in stair climbing ability in treated patients compared to a placebo control group. "The approval of Duvyzat (givinostat) provides another significant treatment option for people living with Duchenne muscular dystrophy,” said Sharon Hesterlee, PhD, Chief Research Officer, MDA. “As more drugs are approved for DMD we look forward to understanding if and how they might be used in combination.” Pier Lorenzo Puri’s group based at Sanford Burnham Prebys Medical Discovery Institute in San Diego performed the studies that led to the discovery of HDAC inhibitors (HDACi) for treatment of DMD since 2004. These studies were performed in close collaboration with the lab Puri led in Rome in Scientific Park of Castel Romano (2002-2007) and at Fondazione Santa Lucia (2008-2018). “Muscular Dystrophy Association’s funding was fundamental for the discovery of HDACi in the treatment of Duchenne muscular dystrophy. We are grateful to MDA to have enabled studies that support the important pre-clinical evidence that HDACi exerted beneficial effects in the mouse model of DMD. These studies provided the initial experimental evidence that led me to contact Italfarmaco to test givinostat, as a HDACi that was already in clinical trial for other diseases and could have been easily repurposed for DMD,” said Pier Lorenzo Puri, M.D., Sanford Burnham Prebys Medical Discovery Institute. For decades, MDA has awarded many research grants to fund investigators worldwide and their promising early-stage science. These grants support the foundational discoveries that enable future clinical translation, such as with Duvyzat (givinostat). “Since the way Duvyzat (givinostat) works is different from other treatments for Duchenne muscular dystrophy, the combination of this new drug with other therapies may further improve the lives of our patients living with Duchenne muscular dystrophy,” said Barry Byrne, M.D., Ph.D., Chief Medical Advisor, MDA and the Associate Chair of Pediatrics and Director of the Powell Gene Therapy Center at the University of Florida. “We’re excited to celebrate this additional treatment option for people living with Duchenne muscular dystrophy. This approval demonstrates the FDA’s understanding of the importance of slowing disease progression in diseases like Duchenne, and how meaningful that is to the community. We are proud to partner with the FDA to help speed the approval of new therapies that slow disease progression and ensure the voice of patients and their families is heard,” said Paul Melmeyer, Vice President, Public Policy and Advocacy, MDA. “Being part of the Muscular Dystrophy Association is everything. From the MDA Care Center Network and Resource Center to the industry development, educational resources, and advocacy and so much more, because of MDA when people are diagnosed, they have such a wide range of resources. When my son Conner was diagnosed nine years ago, there were 10 drugs in the pipeline for DMD and steroids possibly if you chose to do that -- and really not much else. With this new FDA approval, it's amazing because of the MDA, they've funded the seed research, for a lot of the drugs that are now in the pipeline or already approved. And parents have choices. It is more than fair to say that the Muscular Dystrophy Association has improved lives. My son is an example,” said Jessica Curran, MDA family member and mother of Conner who lives with Duchenne muscular dystrophy. About Duchenne muscular dystrophy (DMD) Duchenne muscular dystrophy (DMD) is a rare and progressive genetic muscle disease caused by the lack of a critical membrane-stabilizing protein called dystrophin, which results in muscle degeneration and weakness. DMD symptom onset is in early childhood, usually between ages 2 and 3. The disease primarily affects boys, but in rare cases it can affect girls. In Europe and North America, the prevalence of DMD is approximately 6 per 100,000 individuals. Doctors often diagnose the disease between ages 3 and 6 when children show early signs of significant muscle weakness, such as delayed ability to sit, stand, or walk and difficulties learning to speak. Over time, DMD becomes fatal as muscle degeneration disrupts lung and heart function. MDA’s Legacy in Duchenne Muscular Dystrophy Research Since our inception, MDA has invested over $229 million in research for Duchenne and Becker muscular dystrophy. The discovery of the dystrophin gene in the 1980s by MDA-funded research marked the beginning of our understanding of Duchenne and Becker muscular dystrophy. This discovery has been foundational in the development of treatments like Duvyzat (givinostat). For support and guidance, families and medical professionals in the neuromuscular community may contact the MDA Resource Center, ResourceCenter@mdausa.org. About Muscular Dystrophy Association Muscular Dystrophy Association (MDA) is the #1 voluntary health organization in the United States for people living with muscular dystrophy, ALS, and related neuromuscular diseases. For over 70 years, MDA has led the way in accelerating research, advancing care, and advocating for the support of our families. MDA's mission is to empower the people we serve to live longer, more independent lives. To learn more visit mda.org and follow MDA on Instagram, Facebook, X, Threads, TikTok, LinkedIn, and YouTube. Attachment New FDA Drug Approval for Duchenne Muscular Dystrophy Mary Fiance, Vice President, Strategic Communications Muscular Dystrophy Association press@mdausa.org

Phase 3Drug ApprovalClinical Result

18 Mar 2024

·www.fiercebiotech.com

Chinese biotech's MASH candidate reduces liver fat in phase 2 trial

Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. Chipscreen Biosciences' metabolic dysfunction-associated steatohepatitis (MASH) candidate reduced patients' liver fat levels, adding further momentum to drugs aimed at the condition. The Shenzhen, China-based biotech says chiglitazar produced “significant and dose-dependent reductions” in liver fat content from baseline compared to placebo during a phase 2 study, according to a Monday press release. The company did not provide data to support the primary endpoint win and said more will be revealed at an upcoming conference or in a medical journal. Chipscreen also reported that patients given chiglitazar “showed significant or dose-dependent trend of improvements” on a number of secondary endpoints. As for safety, Chipscreen kept it short and sweet: “The overall safety is good.” Chiglitazar has already been approved in China as a treatment for type 2 diabetes in addition to diet and exercise, with Chipscreen looking to expand its use in combination with anti-diabetic drug metformin. The sampling of phase 2 data teased Monday comes days after Madrigal Pharmaceuticals scored the first-ever FDA approval to treat MASH, which has previously been known as non-alcoholic steatohepatitis (NASH). The much-hyped class of GLP-1 medications have also shown promise as potential MASH treatments. Chipscreen’s metabolic ambitions have grown in parallel with the biotech’s oncology work, centered on its epigenetic modulator, chidamide. The drug is approved in China as a treatment for peripheral T-cell lymphoma and breast cancer, with ongoing trials testing it in patients with diffuse large B cell lymphoma and non-small cell lung cancer.

Drug ApprovalClinical ResultPhase 2

100 Deals associated with Chidamide

External Link

KEGG	Wiki	ATC	Drug Bank
-	Chidamide	L01XX	DB06334

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Diffuse Large B-Cell Lymphoma	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	24 Apr 2024
Adult T-Cell Leukemia-Lymphoma	JP	Meiji Seika Pharma Co., Ltd.	23 Jun 2021
Breast Cancer	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	20 Nov 2019
Peripheral T-Cell Lymphoma	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	23 Dec 2014

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Advanced breast cancer	Phase 3	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Jul 2015
Hormone receptor positive breast cancer	Phase 3	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Jul 2015
Colorectal Cancer	Phase 3	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	-
Acute Myeloid Leukemia	Phase 2	CN	Guangdong General Hospital	31 May 2024
T-cell lymphoma recurrent	Phase 2	TW	Great Novel Therapeutics Biotech & Medicals Corp.	01 Apr 2024
Hepatocellular Carcinoma	Phase 2	TW	Great Novel Therapeutics Biotech & Medicals Corp.	25 Apr 2023
Hormone receptor positive HER2 negative breast cancer	Phase 2	CN	Hunan Cancer Hospital	07 Feb 2023
PD-L1 positive Non-Small Cell Lung Cancer	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	26 Oct 2022
Diffuse large B-cell lymphoma recurrent	Phase 2	-	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Jun 2022
metastatic non-small cell lung cancer	Phase 2	US	HUYA Bioscience International LLC	14 Mar 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04231448 (DEB, ASCO2024) Manual	Phase 3	Diffuse Large B-Cell Lymphoma First line MYC expression \| BCL2 expression	423	Tucidinostat plus R-CHOP	gpdrpmzynj(tjmrqrdbzq) = ddchpcnxwh desmdgqtru (bdrlijllaw, 48.9 - 67.6) View more	Positive	02 Jun 2024
NCT04231448 (DEB, ASCO2024) Manual	Phase 3		423	Placebo plus R-CHOP	gpdrpmzynj(tjmrqrdbzq) = hmqbtjiejf desmdgqtru (bdrlijllaw, 35.7 - 56.1) View more	Positive	02 Jun 2024
NCT05527912 (Smart Start, ASCO2024)	Phase 2	Diffuse Large B-Cell Lymphoma MYC \| BCL2	34	Rituximab, chidamide, and zanubrutinib (ZCR)	vlvcsepnlc(cuhgchxjqy) = qcafieieug vbajwcgyxt (czdaznprhd )	Positive	24 May 2024
NCT05478473 (ASCO2024)	Phase 2	Unresectable Melanoma Second line	21	Tucidinostat 30 mg	wtsoamkgtb(pvkcmyzhgt) = xiywsedovl hxdygietfn (gycmepfacx, 9.7 - 53.5) View more	Positive	24 May 2024
NCT05951855 (EHA2024) Manual	Phase 2	Acute Myeloid Leukemia	11	SELINEXOR+CHIDAMIDE	vmkkatwiah(qpmtxpmqst) = iiqbmimzyk cyqklugwyu (apdypzkoza ) View more	Positive	14 May 2024
Phase II study (EHA2024)	Phase 2	histone methylation mutations \| histone acetylation mutations \| TP53 mutations	22	Chidamide 20 mg	gbwlnyfzxz(fwvgdevznc) = yfohvzheok jfrrfbhuey (jzvkomabuy, 59.7 - 94.8) View more	Positive	14 May 2024
NCT05967949 (EHA2024)	Not Applicable	Peripheral T-Cell Lymphoma Maintenance	58	Chidamide maintenance after first-line treatment	quwkbmaaqs(dznkkanetf) = The most common toxicities were hematologic toxicities, including neutropenia (42, 72.4%), anemia (23, 39.7%), thrombocytopenia (29, 50.0%) hqxnblqqna (kbkufouvhh ) View more	Positive	14 May 2024
NCT05967949 (EHA2024)	Not Applicable	Peripheral T-Cell Lymphoma Maintenance	58	Chidamide maintenance after salvage treatment		Positive	14 May 2024
EHA2024	Not Applicable	MYC protein overexpression \| BCL2 protein overexpression \| CREBBP/EP300 mutations	42	Chidamide combined with R-CHOP-like regimen	calzunduxr(jkgwqyfkve) = yeutnfpjdz kbthsyqrgx (uplnvghwwu ) View more	Positive	14 May 2024
EHA2024	Not Applicable		42	R-CHOP-like chemotherapy regimen alone	calzunduxr(jkgwqyfkve) = cmwdeewqsr kbthsyqrgx (uplnvghwwu ) View more	Positive	14 May 2024
EHA2024	Phase 2	Maintenance NK/T lymphoma	45	Chidamide with Azacitidine and CHOP	mplfhauljb(rxlevmxdtv) = xdciufukmz svubkmqqnr (nrdkncwwmt ) View more	Positive	14 May 2024
EHA2024	Phase 2	Maintenance NK/T lymphoma	45	Maintenance Treatment with Chidamide	mplfhauljb(rxlevmxdtv) = ugxhexyvma svubkmqqnr (nrdkncwwmt ) View more	Positive	14 May 2024
ChiCTR2300067593 (ASH2023)	Phase 2	Acute Myeloid Leukemia Maintenance	36	Chidamide 5 mg/d + Azacitidine 75 mg/m2/d	huhfpriexa(glgdbouqos) = xiyjfxdgnz bcgiwludhe (iwtgxmbcws, 6.5 - 18.1) View more	-	11 Dec 2023
ASH2023	Not Applicable	Acute Myeloid Leukemia \| Myelodysplastic Syndromes	-	Fractionated busulfan + Chidamide	puhdhikhhd(kirgbmrayy) = socsxesapz tskkgtxdai (newnwktbmg ) View more	-	11 Dec 2023

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