A Phase 1, Open-label, Dose-finding Study of CC-91633 (BMS-986397) in Subjects With Relapsed or Refractory Acute Myeloid Leukemia or Relapsed or Refractory Higher-Risk Myelodysplastic Syndromes

Study CC-91633-AML-001 is a Phase 1, open-label, dose escalation and expansion, first-in-human (FIH) clinical study of CC-91633 (BMS-986397) in participants with relapsed or refractory acute myeloid leukemia (R/R AML) or in participants with relapsed or refractory higher-risk myelodysplastic syndromes (R/R HR-MDS). The Dose Escalation part (Part A) of the study will enroll participants with R/R AML and R/R HR-MDS and will evaluate the safety and tolerability of escalating doses of CC-91633 (BMS-986397), administered orally, and determine the maximum tolerated dose (MTD) or preliminary recommended Phase 2 doses (RP2D) and schedule. Throughout the study, final decisions on dose escalation/de-escalation will be made by the safety review committee (SRC). Approximately 60 participants may be enrolled in Part A of the study.
The expansion part (Part B) will confirm tolerability of the selected doses and schedules and evaluate whether efficacy is in a range that warrants further clinical development. Approximately 60 response-evaluable subjects per indication (R/R AML or R/R HR-MDS) may be enrolled.
Parts A and B will consist of 3 periods: Screening, Treatment, and Follow-up.

开始日期2021-12-02

申办/合作机构

Celgene Corp.

100 项与 CC-91633 相关的临床结果

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100 项与 CC-91633 相关的转化医学

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100 项与 CC-91633 相关的专利（医药）

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项与 CC-91633 相关的文献（医药）

2023-01-01·Blood Reviews

Targeting cereblon in hematologic malignancies

Review

作者: Fuchs, Ota

The protein cereblon (CRBN) is a substrate receptor of the cullin 4-really interesting new gene (RING) E3 ubiquitin ligase complex CRL4^CRBN. Targeting CRBN mediates selective protein ubiquitination and subsequent degradation via the proteasome. This review describes novel thalidomide analogs, immunomodulatory drugs, also known as CRBN E3 ubiquitin ligase modulators or molecular glues (avadomide, iberdomide, CC-885, CC-90009, BTX-1188, CC-92480, CC-99282, CFT7455, and CC-91633), and CRBN-based proteolysis targeting chimeras (PROTACs) with increased efficacy and potent activity for application in hematologic malignancies. Both types of CRBN-binding drugs, molecular glues, and PROTACs stimulate the interaction between CRBN and its neosubstrates, recruiting target disease-promoting proteins and the E3 ubiquitin ligase CRL4^CRBN. Proteins that are traditionally difficult to target (transcription factors and oncoproteins) can be polyubiquitinated and degraded in this way. The competition of CRBN neosubstrates with endogenous CRBN-interacting proteins and the pharmacology and rational combination therapies of and mechanisms of resistance to CRL4^CRBN modulators or CRBN-based PROTACs are described.

100 项与 CC-91633 相关的药物交易

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研发状态

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
骨髓增生异常综合征	临床1期	加拿大	Celgene Corp.	2021-12-02
骨髓增生异常综合征	临床1期	西班牙	Celgene Corp.	2021-12-02
骨髓增生异常综合征	临床1期	英国	Celgene Corp.	2021-12-02
骨髓增生异常综合征	临床1期	美国	Celgene Corp.	2021-12-02
骨髓增生异常综合征	临床1期	澳大利亚	Celgene Corp.	2021-12-02
复发性急性髓细胞白血病	临床1期	西班牙	Celgene Corp.	2021-12-02
复发性急性髓细胞白血病	临床1期	澳大利亚	Celgene Corp.	2021-12-02
复发性急性髓细胞白血病	临床1期	加拿大	Celgene Corp.	2021-12-02
复发性急性髓细胞白血病	临床1期	英国	Celgene Corp.	2021-12-02
复发性急性髓细胞白血病	临床1期	美国	Celgene Corp.	2021-12-02