A Single-arm, Multicenter, Prospective Clinical Study of CHiR (chidamide, Zanubrutinib, and Lenalidomide) for Newly Diagnosed MYC- and BCL2-positive Diffuse Large B-cell Lymphoma (DLBCL) in Elderly Patients Intolerant to Chemotherapy.

The objective of exploring the application of CHiR is to evaluate its therapeutic efficacy and safety in newly diagnosed elderly patients with diffuse large B-cell lymphoma (DLBCL) aged 70 and above, and to investigate the genetic subtypes that may benefit from CHiR. The primary endpoint is the complete remission rate (CRR) at the end of 8 cycles.

Start Date01 Feb 2025

Sponsor / Collaborator

Ningbo University

ChiCTR2400094864

/ SuspendedNot ApplicableIIT

Chidamide in combination with third-generation epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) in patients with advanced lung adenocarcinoma who have failed third-generation EGFR-TKI therapy: a multicenter exploratory single-arm clinical study

Start Date01 Jan 2025

Sponsor / Collaborator

Affiliated Hospital of Guangdong Medical University

NCT06497985

/ RecruitingPhase 3

A Randomised, Open-label, Multicenter Phase III Study of Tucidinostat in Combination With Sintilimab and Bevacizumab in MSS/pMMR Colorectal Cancer Patients Who Failed at Least Second-line Standard Therapies

A randomised, open-label, multicenter phase III study to evaluate the efficacy and safety of tucidinostat in combination with sintilimab and bevacizumab versus fruquintinib monotherapy in MSS/pMMR colorectal cancer patients.

Start Date27 Nov 2024

Sponsor / Collaborator

Shenzhen Chipscreen Biosciences Co., Ltd.

100 Clinical Results associated with Chidamide

100 Translational Medicine associated with Chidamide

100 Patents (Medical) associated with Chidamide

386

Literatures (Medical) associated with Chidamide

31 Dec 2024·Hematology

A retrospective study of an irradiation-based conditioning regimen and chidamide maintenance therapy in T-ALL/LBL

Article

Author: Lai, Sihan ; Han, Ying ; Wang, Xueying ; He, Ying ; He, Guangcui ; Zhang, Lilan ; Liu, Fang ; Li, Yecheng ; Su, Yi ; Deng, Yan ; Yi, Hai ; Zhang, Shan

OBJECTIVEST-cell acute lymphoblastic leukemia/lymphoblastic lymphoma (T-ALL/LBL) are highly malignant and aggressive hematologic tumors for which there is no standard first-line treatment. Chidamide, a novel histone deacetylase inhibitor, shows great promise. We assessed the efficacy and safety of an irradiation-containing conditioning regimen for allogeneic hematopoietic stem cell transplantation (allo-HSCT) and post-transplantation chidamide maintenance in patients with T-ALL/LBL.METHODSWe retrospectively analyzed the clinical data of six patients with T-ALL/LBL who underwent allo-HSCT with a radiotherapy-containing pretreatment regimen and post-transplant chidamide maintenance therapy. The endpoints were relapse, graft-versus-host disease (GVHD), transplant-related mortality (TRM), progression-free survival (PFS), overall survival (OS), and adverse events (AEs).RESULTSAll of the patients had uneventful post-transplant hematopoietic reconstitution, and all achieved complete molecular remission within 30 days. All six patients survived, and two relapsed with a median relapse time of 828.5 (170-1335) days. The 1-year OS rate was 100%, the 2-year PFS rate was 66.7%, and the TRM rate was 0%. After transplantation, two patients developed grade I-II acute GVHD (2/6); grade III-IV acute and chronic GVHD were not observed. The most common AEs following chidamide administration were hematological AEs, which occurred to varying degrees in all patients; liver function abnormalities occurred in two patients (grade 2), and symptoms of malaise occurred in one patient (grade 1).CONCLUSIONChidamide maintenance therapy after T-ALL/LBL transplantation is safe, but the efficacy needs to be further investigated.

02 Dec 2024·Clinical Cancer Research

Combinations of HDAC Inhibitor and PPAR Agonist Induce Ferroptosis of Leukemic Stem Cell–like Cells in Acute Myeloid Leukemia

Article

Author: Xie, Chendi ; Qiu, Yi ; Zha, Jie ; Qin, Dongmei ; Zhou, Hui ; Jia, Shuman ; Zhou, Ziwei ; Zhou, Jie ; Xu, Bing

AbstractPurpose:Leukemic stem cells (LSC) are responsible for leukemia initiation, relapse, and therapeutic resistance. Therefore, the development of novel therapeutic approaches targeting LSCs is urgently needed for patients with acute myeloid leukemia (AML).Experimental Design:The LSC-like cell lines (KG-1α and Kasumi-1) and CD34+ primary AML cells purified from patients with AML (n = 23) treated with CS055 and/or chiglitazar and were analyzed for viability, death, and colony formation assay. We performed RNA sequencing, glutamate release, intracellular glutathione, lipid reactive oxygen species, transmission electron microscopy, and Western blotting assay and confirmed ferroptosis in LSC-like cells. The luciferase reporter, co-immunoprecipitation, histone deacetylase 3 (HDAC3)-shRNA/HDAC3/deacetylase-deficient LSC-like cell lines, histidine pull-down, and chromatin immunoprecipitation assays performed to clarify the molecular mechanism of CS055/chiglitazar in LSC-like cells. We also established cell-derived xenograft and patient-derived xenograft mouse models to evaluate the therapeutic efficacy of CS055/chiglitazar against AML in vivo.Results:We report that the HDAC inhibitor CS055, in combination with peroxisome proliferator–activated receptor pan-agonist (chiglitazar), synergistically targets leukemic stem-like cells from leukemia cell lines and patient samples while sparing normal hematopoietic progenitor cells. Mechanistically, chiglitazar enhances the inhibitory effect of CS055 on HDAC3 and induces ferroptosis in LSC-like cells by downregulating the expression of ferroptosis suppressor SLC7A11. In fact, the inhibition of HDAC3 increases H3K27AC levels in the promoter region of activating transcription factor 3 (ATF3), a transcriptional repressor of the SLC7A11 gene, and upregulates the expression of ATF3. In contrast, ATF4, a SLC7A11 activator, is suppressed by HDAC3 inhibition.Conclusions:Our findings suggest that treatment with CS055 combined with chiglitazar will target LSCs by inducing ferroptosis and may confer an effective approach for the treatment of AML.

01 Dec 2024·Annals of Hematology

Comparison of tucidinostat with CHOP-like versus CHOP-like in first-line treatment of peripheral T-cell lymphoma: a single-center real-world study

Article

Author: Su, Liping ; Yu, Qinchuan ; Zheng, Yuping ; Wen, Xiaolian ; Wang, Lieyang ; Wang, Yanli ; Han, Wei'e ; Guan, Tao

Tucidinostat has been approved by the Chinese FDA for relapsed/refractory Peripheral T cell lymphoma (PTCL), but its efficacy in newly diagnosed PTCL has not been confirmed. In this study, we aimed to compare the efficacy of tucidinostat combined with CHOP-like (C + CHT) versus CHOP-like alone (CHT) in newly diagnosed PTCL patients. Of the PTCL patients, 109 were newly diagnosed. Patients in the C + CHT group who achieved objective response received tucidinostat maintenance therapy. A total of 36 pairs (n = 72) were matched at a ratio of 1:1 using propensity scoring. The matching criteria included: whether the Prognostic index for the peripheral T-cell lymphoma-not otherwise specified subtype (PIT) was ≥ 2, the pathological subtype, age > 60 years, and gender (matching tolerance = 0.024). A significantly higher objective response rate (ORR) (P = 0.016), 2-year progression-free survival (PFS) (P = 0.026), and 2-year survival rate (P = 0.017) was observed for the C + CHT group as compared to the CHT group. After propensity score matching (PSM), the C + CHT group as compared to the CHT group displayed significantly longer PFS (P = 0.035) and overall survival (OS) (P = 0.029). For the C + CHT group in the per-protocol set, the effect values showed a significant benefit in terms of both PFS (P = 0.027) and OS (P = 0.019). Common grade 3-4 haematological adverse events (AEs), had comparable incidence in each group; while common non-haematological AEs, including elevated AST and ALT were higher in the C + CHT group than in the CHT group. Our study suggests that the tucidinostat with CHOP-like regimen and sequential tucidinostat maintenance after objective remission provides a promising therapeutic approach for treating newly diagnosed PTCL patients.

News (Medical) associated with Chidamide

27 Dec 2024

·cerenoscientific.com

Cereno Scientific has enrolled 9 additional patients in its Expanded Access Program with CS1 providing more long-term safety and efficacy data in rare disease PAH

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announced that 9 additional patients have entered its Expanded Access Program (EAP) with drug candidate CS1 in rare disease pulmonary arterial hypertension (PAH). In total, the EAP now includes 10 patients with the possibility of more patients being included in the coming months. The additional data collected on the patients in the EAP will strengthen the long-term safety and efficacy documentation of CS1 and support regulatory interactions for future clinical trials. “We are very pleased to see the high interest from patients and physicians to continue with the treatment of CS1 after the completed Phase IIa study,” said Sten R. Sörensen, CEO, Cereno Scientific. “From a drug development perspective, it is very valuable for us to be able to collect long-term clinical data on CS1 as we move forward with our plans for the next clinical program.” Drug candidate CS1 has been approved by the FDA for an Expanded Access Program as an extension of the Phase IIa trial in PAH. This program allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through the recently entered collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The EAP, an FDA-approved protocol, enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients supporting required regulatory interactions and planning future Phase IIb or pivotal Phase III trials. For further information, please contact: Tove Bergenholt, Head of IR & Communications Email: tove.bergenholt@cerenoscientific.com Phone: +46 732- 33 62 46 Sten R. Sörensen, CEO Email: sten.sorensen@cerenoscientific.com Phone: +46 73-374 03 74 About CS1 Drug candidate CS1 is an HDAC inhibitor (HDACi) that works through epigenetic modulation, being developed as a safe, effective and disease-modifying treatment for the rare disease pulmonary arterial hypertension (PAH). CS1 targets the root mechanism of the disease, aiming to reverse the pathological vascular remodeling of the small lung arteries. In a Phase IIa study, CS1 successfully met the primary endpoint of safety and tolerability. CS1 further showed compelling positive impact on exploratory clinical efficacy parameters over the 12-week treatment period. The Phase IIa data, together with preclinical data from the HDACi program, directly demonstrates the HDACi program’s dose-dependent positive impact on reverse remodeling in small lung arteries. This provides a basis of assumption that CS1 may act with disease-modifying capacity in PAH. In preclinical cardiovascular disease models, HDAC inhibitors have also shown anti-fibrotic, anti-inflammatory, pulmonary pressure-reducing, and anti-thrombotic effects. CS1’s unique efficacy profile aligns well with the underlying mechanisms of disease that drives the progression of PAH, positioning it to address the critical unmet need for more effective treatment options. The goal of CS1's development is to enhance and extend life for patients with PAH. CS1 is part of Cereno’s HDACi portfolio, untapping the potential of epigenetic modulation in rare cardiovascular and pulmonary diseases. CS1 has been granted orphan drug status in both the US and EU. CS1 has been approved by the FDA for an Expanded Access Program (EAP) as an extension of the Phase IIa trial in PAH, which enables Cereno to obtain valuable long-term safety and efficacy data of CS1 in PAH patients. Ten patients are currently enrolled in the program, which allows patients who have completed the Phase IIa trial to continue CS1 treatment if deemed suitable by physicians in the study. Through a collaboration with innovative medical company Fluidda, their non-invasive imaging technology called Functional Respiratory Imaging (FRI) will be used on certain patients enrolled in the EAP to visualize how long-term use of CS1 influences changes in pulmonary arteries. The data obtained by the EAP supports required regulatory interactions and planning future Phase IIb or pivotal Phase III trials. About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease Idiopathic Pulmonary Fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information can be found on www.cerenoscientific.com. Read PDF Share

Phase 2Phase 1Clinical ResultOrphan Drug

20 Dec 2024

·cerenoscientific.com

Cereno Scientific announces that the registration of warrants and convertibles to Fenja and Arena has been completed and that delivery of the warrants has been initiated

20 Dec 2024 07:00Regulatory Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, announced on 11 November 2024 that the Company has entered into a financing agreement (the “Financing Agreement”) with Fenja Capital II A/S and the US-based investor Arena Investors, LP (the “Financiers”) securing loan financing of at least 250 MSEK. The Financing Agreement is divided into three components: (i) a cash loan in two tranches totaling 175 MSEK (the “Loan”), (ii) the issue of convertible loans of 75 MSEK to the Financiers (the “Convertibles”), and (iii) the issue without consideration of 5,749,017 warrants to the Financiers (the “Warrants”). The Company today announce that the Convertibles and the Warrants have been registered with the Swedish Companies Registration Office and that the transfer of the Warrants to the Financiers’ custody accounts has been initiated. Completed registration and ongoing delivery The Company hereby announces that the Convertibles and the Warrants have been registered with the Swedish Companies Registration Office and that the delivery of the Warrants following their connection to Euroclear has been initiated to the custody accounts designated by the Financiers. Main terms of the Convertibles, the Warrants and the Loan The convertible loans of 75 MSEK is represented by convertible promissory notes in the nominal amount of SEK 1 per Convertible. The Convertibles will be due for repayment on 30 April 2026 (the "Maturity Date"), unless Conversion has occurred before that date. The rate of interest on the Convertibles are calculated quarterly and determined at the percentage rate per annum which is the aggregate of STIBOR90 with an additional 11 percentage points. The Company has a right but no obligation to repay the Convertibles, in whole or in part, at any time prior to the Maturity Date without separate costs. In connection with any premature repayment, accrued interest of the amount so prepaid should be paid at the same time. During the term of the Convertibles, the Financiers may demand conversion of all or part of the Convertibles into new B shares in the Company at a conversion price fixed at SEK 6.09. Presuming full conversion of the Convertibles the number of shares in Cereno Scientific will increase by 12,315,270 B-shares and the share capital will increase by SEK 1,231,527 corresponding to a dilution effect of approximately 4.19 per cent of the currently outstanding shares in the company and approximately 4.10 per cent of the currently outstanding votes in the company. In relation to the Warrants, the Financiers are entitled to subscribe for one new B share for each Warrant at a subscription price of SEK 6.82 per B share during the term of the Warrants (up to and including 8 November 2029). Exercise of the Warrants can be done during the whole term of the Warrants. Upon full exercise of the Warrants, the company will receive additional issue proceeds of approximately 39.2 MSEK. Presuming full exercise of the Warrants, the number of shares in Cereno Scientific will increase by 5,749,017 B-shares and the share capital will increase by SEK 574,901.70 corresponding to a dilution effect of approximately 2.00 per cent of the currently outstanding shares in the company and 1.96 per cent of the currently outstanding votes in the company. The Loan is divided into two tranches where Tranche 1 consists of a cash loan of 125 MSEK which was paid out in connection with the signing of the Financing Agreement. Tranche 2 consists of a cash loan of 50 MSEK and is conditional upon the Company having received approval by the FDA regarding CS1 for a phase IIB study or a pivotal study for phase III as well as certain additional financial conditions being fulfilled. The Loan was subject to a customary setup fee amounting to approximately 3,87 per cent of the funding under the Financing Agreement. Parts of Tranche 1 of the Loan have been used to repay the currently outstanding loan to Fenja of approximately 91 MSEK. The interest rate of the Loan under the Financing Agreement is fixed annually starting at the time of payment and bears an annual interest rate set at the percentage rate per annum which is the sum of STIBOR plus 11 percentage points. Repayment of the Loan (both Tranches, if applicable) shall be made on 30 April 2026. Further fundamental information about the Convertibles, the Warrants and the Financing Agreement can be found in the press release of 11 November 2024: Press release | Cereno Scientific. For further information, please contact: Eva Jagenheim, CFO Email: eva.jagenheim@cerenoscientific.com Phone: +46 70 492 35 63 Sten R. Sörensen, CEO Email: sten.sorensen@cerenoscientific.com Phone: +46 73-374 03 74 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease Idiopathic Pulmonary Fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information at www.cerenoscientific.com. Read PDF Share

Phase 1Phase 2Clinical Result

06 Dec 2024

·cerenoscientific.com

Cereno Scientific to present preclinical data for drug candidate CS585 at the ASH Annual Meeting and Exposition 2024

Cereno Scientific (Nasdaq First North: CRNO B), an innovative biotech pioneering treatments to enhance and extend life for people with rare cardiovascular and pulmonary diseases, today announces that an abstract on the preclinical drug candidate, novel IP receptor agonist CS585 will be presented at the ASH Annual Meeting and Exposition 2024, in San Diego 7-10 December 2024. The abstract titled “Selectivity and Long Action of In Vivo Efficacy of CS585, a Novel Prostacyclin Receptor Agonist, Compared to FDA-Approved Prostacyclin Agonists Iloprost and Selexipag in the Prevention of Thrombosis”, was authored by L. Stanger, M Flores, K Goerger and M. Holinstat, at the University of Michigan, Ann Arbor, USA; and B. Dahlöf, Cereno Scientific. The poster will be presented by Livia Stanger, Graduate student at the Holinstat Lab at University of Michigan, led by Prof. Michael Holinstat, Professor in the Department of Pharmacology, the Department of Internal Medicine (Division of Cardiovascular Medicine), and the Department of Vascular Surgery at the University of Michigan. Prof. Holinstat leads Cereno’s development programs at the University of Michigan and is Director of Translational Research at Cereno. Presentation Date: Sunday, 8 December 2024, 18:00–20:00 PST Part of Session: Platelets and Megakaryocytes: Basic and Translational: Poster II Read more about ASH Annual Meeting and Exposition 2024. About ASH The ASH (American Society of Hematology) Annual Meeting and Exposition is one of the world's largest conferences for professionals in hematology, including clinicians, scientists, and researchers. The conference features trends and discoveries in hematology followed by panel discussions and Q&As. This year's edition marks the 66th conference since its inception, and the conference is an important part of the development and growth in hematology. About CS585 Drug candidate CS585 is an oral, highly potent, and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular disease. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. A license agreement for drug candidate CS585 with the University of Michigan provides Cereno exclusive rights to further development and commercialization of CS585. In early November 2023, CS585 was highlighted by top-tier medical journal Blood as a promising novel anti-thrombotic strategy without risk of bleeding. New preclinical data for Cereno Scientific’s novel IP Receptor Agonist CS585 was presented at ESC Congress 2024, indicating that CS585 inhibits platelet activation and clot formation up to 24 hours post-administration. For further information, please contact: Julia Fransson, Director Business Development Email: julia.fransson@cerenoscientific.com Phone: +46 708-14 31 75 Sten R. Sörensen, CEO Email: sten.sorensen@cerenoscientific.com Phone: +46 73-374 03 74 About Cereno Scientific AB Cereno Scientific is pioneering treatments to enhance and extend life. Our innovative pipeline offers disease-modifying drug candidates to empower people suffering from rare cardiovascular and pulmonary diseases to live life to the full. Lead candidate CS1 is an HDACi that works through epigenetic modulation, being developed as a safe, effective and disease modifying treatment for rare disease Pulmonary Arterial Hypertension (PAH). A Phase IIa trial evaluating CS1’s safety, tolerability, and exploratory efficacy in patients with PAH demonstrated that CS1 was safe, well-tolerated and showed a positive impact on exploratory clinical efficacy parameters. An Expanded Access Program enables patients that have completed the Phase IIa trial to gain access to CS1. HDACi CS014, in Phase I development, is a new chemical entity with disease-modifying potential. CS014 employs a multi-modal mechanism of action as an epigenetic modulator, targeting key unmet needs in patients with rare disease Idiopathic Pulmonary Fibrosis (IPF). Cereno Scientific is also pursuing a preclinical program with CS585, an oral, highly potent and selective prostacyclin (IP) receptor agonist that has demonstrated the potential to significantly improve disease mechanisms relevant to cardiovascular diseases. While CS585 has not yet been assigned a specific indication for clinical development, preclinical data indicates that it could potentially be used in indications like Thrombosis prevention without increased risk of bleeding and Pulmonary Hypertension. The Company is headquartered in GoCo Health Innovation City, in Gothenburg, Sweden, and has a US subsidiary; Cereno Scientific Inc. based in Kendall Square, Boston, Massachusetts, US. Cereno Scientific is listed on the Nasdaq First North (CRNO B). The Certified Adviser is Carnegie Investment Bank AB, certifiedadviser@carnegie.se. More information to be found on www.cerenoscientific.com. Read PDF Share

Phase 1License out/inPhase 2Clinical ResultASH

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.

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Indication	Highest Phase	Country/Location	Organization	Date
Brain metastases	Phase 3	IT	HUYA Bioscience International LLC	12 Aug 2021
Brain metastases	Phase 3	AT	HUYA Bioscience International LLC	12 Aug 2021
Brain metastases	Phase 3	AU	Bristol Myers Squibb Co.	12 Aug 2021
Brain metastases	Phase 3	IT	Bristol Myers Squibb Co.	12 Aug 2021
Brain metastases	Phase 3	JP	HUYA Bioscience International LLC	12 Aug 2021
Brain metastases	Phase 3	FR	HUYA Bioscience International LLC	12 Aug 2021
Brain metastases	Phase 3	NZ	HUYA Bioscience International LLC	12 Aug 2021
Brain metastases	Phase 3	PR	HUYA Bioscience International LLC	12 Aug 2021
Advanced breast cancer	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Jul 2015
Hormone receptor positive breast cancer	Phase 2	CN	Shenzhen Chipscreen Biosciences Co., Ltd.	01 Jul 2015

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04661943 (4490Chidamide, ASH2024)	Phase 2	Hepatitis B Maintenance	95	Chidamide maintenance therapy	xygskrgjvb(ikntkiwqyl) = neutropenia, anemia, thrombocytopenia vpttbwbves (qjlfodnbqt )	Positive	09 Dec 2024
				Chidamide (Observation group)
ASH2024	Not Applicable	-	-	Chidamide	afbjwnwiyw(picfcjraun) = one patient experienced grade 3/4 diarrhea fphfgnzyqh (yfdzyjeqtg ) View more	-	07 Dec 2024
NCT02718066 (HBI-8000-302, SITC2024) Manual	Phase 1/2	Melanoma	39	HBI-8000 + Nivolumab	(xgqidwoyqo) = rawofgkphv gxulurofaf (fbgocrtbrz ) View more	Positive	05 Nov 2024
NCT02955589 (Phase 2B Study, CTgov)	Phase 2	Adult T-Cell Leukemia-Lymphoma	23	HBI-8000	(opxxwszxvi) = halgxnxoyl nzkuqupymt (bpsuvaikwz, zjcjxsnrqh - vaychuojdn) View more	-	19 Sep 2024
NCT05411380 (ESMO2024) Manual	Phase 2	Hormone receptor positive HER2 negative breast cancer \|	43	Tucidinostatcapecitabine	(qhkceppsan) = oyvwzguuws rrbpxqxqtp (rabczuwsqh ) View more	Positive	16 Sep 2024
ChiCTR2400080783 (B-Enefits/SCOG-B001, ESMO2024) Manual	Phase 2	Biliary Tract Neoplasms First line	32	Envafolimabchidamide	(awihzbwzdx) = tipwepldnt sqvipyfozd (bskbspfibn ) View more	Positive	16 Sep 2024
NCT03268889 (Pubmed \| Front Immunol) Manual	Not Applicable	Immunoblastic Lymphadenopathy	66	Chidamide + CHOP	(cybzjljbcu) = xiwfqdwebk jsvqvnttaz (uouuaazjla ) View more	Positive	20 Aug 2024
				CHOP alone	(cybzjljbcu) = xvmlksaigh jsvqvnttaz (uouuaazjla ) View more
NCT04231448 (DEB, ASCO2024) Manual	Phase 3	Diffuse Large B-Cell Lymphoma First line MYC expression \| BCL2 expression	423	Tucidinostat plus R-CHOP	(emfhulhrqk) = zcakyfboni orvykotfbj (bvibmujbun, 48.9 - 67.6) View more	Positive	02 Jun 2024
				Placebo plus R-CHOP	(emfhulhrqk) = cchyaatuwj orvykotfbj (bvibmujbun, 35.7 - 56.1) View more
NCT02987244 (Pubmed)	Phase 2	Peripheral T-Cell Lymphoma Maintenance	85	chidamide (Autologous stem cell transplantation (ASCT))	(aevmqadppx) = qiblymycwi evfawkjfro (xsbbnysiyh ) View more	Positive	28 May 2024
				Chidamide maintenance	(aevmqadppx) = kmovqatfyo evfawkjfro (xsbbnysiyh ) View more
NCT05527912 (ASCO2024) Manual	Phase 2	Diffuse Large B-Cell Lymphoma First line MYC \| BCL2	32	Rituximab, chidamide, and zanubrutinib (ZCR)	(qbvrngyirm) = qasfhznywe beaeizjwzp (gnkombyazc ) View more	Positive	24 May 2024
				Rituximab, chidamide, and zanubrutinib (ZCR) (negative baseline ctDNA results)	(vdpsoireuu) = bfcfvtsene frxgoitmxo (bnxniukpnw )

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