Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

December 17, 2025 updated by: CellCentric Ltd.

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.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This includes patients with Peripheral T-cell lymphoma.

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Bordeaux, France, 33076
        • Completed
        • Institute Bergonie
      • Villejuif, France, 94805
        • Completed
        • Gustave Roussy
  • Spain
      • Badalona, Spain, 08916
        • Recruiting
        • Hospital Germans Trias i Pujol/ ICO Badalona
        • Contact:
          • Albert Oriol-Rocafiguera
      • Barcelona, Spain, 08036
        • Recruiting
        • Hospital Clínic de Barcelona
        • Contact:
          • Laura Rosiñol Dachs
      • Barcelona, Spain, 08035
        • Completed
        • University Hospital Vall d'Hebron
      • Barcelona, Spain, 08908
        • Recruiting
        • ICO L'Hospitalet (Instituto Catalán de Oncología)
        • Contact:
          • Anna Sureda Balari
      • Madrid, Spain, 28034
        • Recruiting
        • Hospital Universitario Ramón y Cajal
        • Contact:
          • María J Blanchard Rodriguez
      • Madrid, Spain, 28041
        • Recruiting
        • Hospital Universitario 12 de octubre
        • Contact:
          • Joaquin Martinez-Lopez
      • Madrid, Spain, 28006
        • Recruiting
        • Hospital Universitario de La Princesa
        • Contact:
          • Adrian Alegre Amor
      • Madrid, Spain, 28031
        • Recruiting
        • Hospital Infanta Leonor
        • Contact:
          • Jose Angel Hernandez- Rivas
      • Madrid, Spain, 28009
        • Recruiting
        • Hospital Universitario Gregorio Maranon
        • Contact:
          • Cristina Encinas Rodriguez
      • Madrid, Spain, 28050
        • Completed
        • CIOCC Hospital Universitario HM Sanchinarro
      • Pamplona, Spain, 31008
        • Recruiting
        • Universidad de Navarra
        • Contact:
          • Paula Rodriguez-Otero
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana
        • Contact:
          • Javier de la Rubia Comos
  • Sweden
      • Stockholm, Sweden
        • Completed
        • Karolinska Comprehensive Cancer Center
  • United Kingdom
      • Bebington, United Kingdom, CH63 4JY
        • Recruiting
        • The Clatterbridge Cancer Centre NHS Foundation Trust,
        • Contact:
        • Principal Investigator:
          • Gillian Brearton, MD
      • Bristol, United Kingdom
        • Recruiting
        • University Hospitals Bristol
        • Contact:
      • Cardiff, United Kingdom
        • Recruiting
        • University Hospital of Wales
        • Contact:
          • Steven Knapper
      • Derby, United Kingdom, DE22 3NE
        • Recruiting
        • Royal Derby Hospital
        • Contact:
        • Principal Investigator:
          • Firas Al-Kaisi, MD
      • Edinburgh, United Kingdom, EH4 2XU
        • Recruiting
        • Western General Hospital
        • Contact:
          • Victoria Campbell
      • Glasgow, United Kingdom, G12 0YN
        • Recruiting
        • Gartnavel General Hospital
        • Contact:
          • Jennifer Travers
      • Leicester, United Kingdom
        • Recruiting
        • Leicester Royal Infirmary
        • Contact:
          • Harriet Walter
      • London, United Kingdom, W1G 6AD
        • Recruiting
        • Sarah Cannon Research Institute UK
        • Contact:
          • Richard Dillon
      • London, United Kingdom
      • London, United Kingdom, EC1A 7BE
        • Recruiting
        • St Bartholomew'S Hospital
        • Contact:
          • Heather Oakervee
      • London, United Kingdom, W1T 7HA
        • Recruiting
        • NIHR University College London Clinical Research Facility
        • Contact:
          • Jenny O'Nions
      • Manchester, United Kingdom
        • Recruiting
        • The Christie Hospital
        • Contact:
          • Tim Somervaille
      • Newcastle upon Tyne, United Kingdom
      • Nottingham, United Kingdom, NG5 1PB
        • Recruiting
        • Nottingham University Hospitals NHS Trust
        • Contact:
          • Dean Smith
      • Oxford, United Kingdom, OX3 7LE
        • Recruiting
        • Cancer and Haematology Centre
        • Contact:
          • Sarah Gooding
      • Southampton, United Kingdom, SO16 6YD
        • Recruiting
        • University Hospital of Southampton
        • Contact:
          • Andy Davies
      • Stoke-on-Trent, United Kingdom, ST4 6QG
        • Recruiting
        • Royal Stoke University Hospital
        • Contact:
          • Kamaraj Karunanithi
    • Surrey
      • Sutton, Surrey, United Kingdom, SM2 5PT
        • Recruiting
        • The Royal Marsden
        • Contact:
          • Charlotte Pawlyn
  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory Winship Cancer Institute
        • Principal Investigator:
          • Dr Nisha Joseph, MD
        • Contact:
    • Indiana
      • Indianapolis, Indiana, United States, 46227
        • Recruiting
        • Community Health Network
        • Contact:
        • Principal Investigator:
          • Pablo M Bedano, MD
    • Maryland
      • Bethesda, Maryland, United States, 20817
        • Recruiting
        • The Center for Cancer and Blood Disorders (CCBD)
        • Contact:
        • Principal Investigator:
          • Victor Priego, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • Nebraska Cancer Specialists
        • Principal Investigator:
          • Stefano Tarantolo, MD
        • Contact:
      • Omaha, Nebraska, United States, 68198-6846
        • Recruiting
        • University of Nebraska Medical Center
        • Principal Investigator:
          • Sarah Holstein, MD
        • Contact:
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Recruiting
        • Penn Medicine - Abramson Cancer Center Perelman
        • Contact:
        • Principal Investigator:
          • Dan Vogl, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CCS1477 dose escalation NHL/MM
CCS1477 monotherapy
Drug: CCS1477
Oral capsule
Experimental: CCS1477 dose escalation AML/Higher risk MDS
CCS1477 monotherapy
Drug: CCS1477
Oral capsule
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - AML
CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
Drug: Venetoclax
Oral tablet
Drug: CCS1477
Oral capsule
Drug: Azacitidine
Powder suspension for Injection
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion NHL
CCS1477 monotherapy, CCS1477 combination with lenalidomide
Drug: Lenalidomide
Oral capsule
Drug: CCS1477
Oral capsule
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - MM
CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone, CCS1477 combination with bortezomib-dexamethasone, CCS1477 combination with ixazomib-dexamethasone, CCS1477 combination with elranatamab, CCS1477 combination with teclistamab, CCS1477 combination with lenalidomide, CCS1477 combination with lenalidomide and daratumumab
Drug: Lenalidomide
Oral capsule
Drug: Ixazomib
Oral capsule
Drug: CCS1477
Oral capsule
Drug: Pomalidomide
oral capsule
Drug: Dexamethasone
oral tablet
Drug: Bortezomib
Powder for solution for injection
Drug: Elranatamab
Solution for injection
Drug: Teclistamab
Solution for injection
Drug: Daratumumab
Solution for injection, concentrate for solution for infusion
Experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS
CCS1477 monotherapy, CCS1477 combination with azacitidine
Drug: CCS1477
Oral capsule
Drug: Azacitidine
Powder suspension for Injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-related adverse events
Time Frame: Up to 12 months
Treatment-related adverse events and serious adverse events
Up to 12 months
Incidence of laboratory abnormalities
Time Frame: Up to 12 months
Laboratory abnormalities characterised by type, frequency, severity and timing
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Response rate
Time Frame: Up to 12 months

Defined as number of patients who have a response according to

  • RECIL criteria (NHL)
  • IMWG criteria (Multiple myeloma)
  • ELN recommendations 2017 (AML)
Up to 12 months
Duration of Response
Time Frame: Up to 12 months
Defined as the time from start of treatment until disease progression
Up to 12 months
AUC of CCS1477
Time Frame: 35 days
Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477
35 days
Cmax of CCS1477
Time Frame: 35 days
Maximum observed plasma concentration (Cmax) of CCS1477
35 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

CellCentric Ltd.

Investigators

  • Principal Investigator: Tim Somervaille, The Christie NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 9, 2019

Primary Completion (Estimated)

March 31, 2027

Study Completion (Estimated)

March 31, 2027

Study Registration Dates

First Submitted

August 12, 2019

First Submitted That Met QC Criteria

August 22, 2019

First Posted (Actual)

August 28, 2019

Study Record Updates

Last Update Posted (Estimated)

December 18, 2025

Last Update Submitted That Met QC Criteria

December 17, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CCS1477-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

At this stage, is not currently planned that any IPD information will be shared with other researchers outside of the Sponsor and Clinical Research Organisations involved in the conduct of this study.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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