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RECRUITINGPHASE1/PHASE2

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

An Open-label Phase I/IIa Study to Evaluate the Safety and Efficacy of CCS1477 as Monotherapy and in Combination in Patients With Advanced Haematological Malignancies.

NCT04068597•CellCentric Ltd.

View on ClinicalTrials.gov

Summary

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 (inobrodib) in patients with Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukaemia or High Risk Myelodysplastic syndrome.

Detailed Description

This includes patients with Peripheral T-cell lymphoma.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Provision of consent
•ECOG performance status 0-2
•Patients with confirmed (per standard disease specific diagnostic criteria), relapsed or refractory haematological malignancies (NHL, MM and AML)
•Must have previously received standard therapy
•Adequate organ function

Exclusion Criteria

•Intervention with any chemotherapy, investigational agents or other anti-cancer drugs within 14 days or 5 half-lives of the first dose
•Major surgical procedure or significant traumatic injury within 4 weeks of the first dose of study treatment
•Strong inhibitors of CYP3A4 or CYP3A4 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
•Strong inducers of CYP3A4 within 4 weeks of the first dose of study treatment
•Patients should discontinue statins prior to starting study treatment
•CYP2C8 substrates with a narrow therapeutic range taken within 2 weeks of the first dose of study treatment
•Any unresolved reversible toxicities from prior therapy \>CTCAE grade 1 at the time of starting study treatment (except alopecia and grade 2 neuropathy)
•Any evidence of severe or uncontrolled systemic diseases
•Any known uncontrolled inter-current illness
•QTcF prolongation (\> 470 msec)

Locations (39)

Emory Winship Cancer Institute

Atlanta, Georgia, United States

Community Health Network

Indianapolis, Indiana, United States

The Center for Cancer and Blood Disorders (CCBD)

Bethesda, Maryland, United States

Nebraska Cancer Specialists

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Penn Medicine - Abramson Cancer Center Perelman

Philadelphia, Pennsylvania, United States

Institute Bergonie

Bordeaux, France

Gustave Roussy

Villejuif, France

Hospital Germans Trias i Pujol/ ICO Badalona

Badalona, Spain

University Hospital Vall D'Hebron

Barcelona, Spain

Key Dates

Start Date

August 9, 2019

Primary Completion Date

March 31, 2027

Completion Date

March 31, 2027

Last Updated

December 18, 2025

Enrollment

250

ESTIMATED participants

Conditions

Haematological MalignancyAcute Myeloid LeukemiaNon Hodgkin LymphomaMultiple MyelomaHigher-risk Myelodysplastic SyndromePeripheral T Cell Lymphoma

Interventions

CCS1477

DRUG

Pomalidomide

DRUG

Dexamethasone

DRUG

Azacitidine

DRUG

Venetoclax

DRUG

Bortezomib

DRUG

Ixazomib

DRUG

Elranatamab

DRUG

Teclistamab

DRUG

Lenalidomide

DRUG

Daratumumab

DRUG

Contacts

Tomasz Knurowski, PhD

CONTACT

07882871299 Tomasz.Knurowski@cellcentric.com

Karen Clegg, MD, MFPM

CONTACT

Karen.Clegg@cellcentric.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 18, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Inclusion Criteria

Exclusion Criteria

Phase I Study of HC-7366 for Acute Myeloid Leukemia

Phase II Study of Pirtobrutinib With Venetoclax In Relapsed-Refractory MCL (Mantle Cell Lymphoma) Patients

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