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Haematological MalignancyPhase 1/2NCT04068597

Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

A Phase 1/2 study testing CCS1477, Pomalidomide and Dexamethasone in people with Haematological Malignancy and Acute Myeloid Leukemia, run by CellCentric Ltd. at 39 sites in 5 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CCS1477, Pomalidomide and Dexamethasone
Could I receive a placebo?
No, everyone receives an active treatment
How many people
250 participants
Where
39 sitesin 5 countries
Study dates
9 Aug 2019to 31 Mar 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 10Show fewer
  • 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)

Trial locations and contacts

39 sites in 5 countries. Contact the study team or a site near you to ask about taking part.

Tomasz Knurowski, PhD contact

07882871299

Tomasz.Knurowski@cellcentric.com

Karen Clegg, MD, MFPM contact

Karen.Clegg@cellcentric.com

39 sites in 5 countries

United Kingdom18 sites, 18 recruiting

  • The Clatterbridge Cancer Centre NHS Foundation Trust,

    Bebington, CH63 4JY

    Gillian Brearton, MD, +44 (0) 151 318 8583, gillian.brearton@nhs.net

    Gillian Brearton, MD

    Recruiting

  • University Hospitals Bristol

    Bristol

    Sally Moore, MD, 44 117 923 0000, sally.moore@uhbw.nhs.uk

    Recruiting

  • University Hospital of Wales

    Cardiff

    Steven Knapper

    Recruiting

  • Royal Derby Hospital

    Derby, DE22 3NE

    Firas Al-Kaisi, MD, +44 (0) 133 278 7971, firas.abed@nhs.net

    Firas Al-Kaisi, MD

    Recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Victoria Campbell

    Recruiting

  • Gartnavel General Hospital

    Glasgow, G12 0YN

    Jennifer Travers

    Recruiting

  • Leicester Royal Infirmary

    Leicester

    Harriet Walter

    Recruiting

  • St Bartholomew's Hospital

    London, EC1A 7BE

    Heather Oakervee

    Recruiting

  • Sarah Cannon Research Institute UK

    London, W1G 6AD

    Richard Dillon

    Recruiting

  • NIHR University College London Clinical Research Facility

    London, W1T 7HA

    Jenny O'Nions

    Recruiting

  • Imperial College

    London

    Aristeidis Chaidos, 44 20 3313 8117, aristeidis.chaidos@nhs.net

    Recruiting

  • The Christie Hospital

    Manchester

    Tim Somervaille

    Recruiting

  • Newcastle upon Tyne Hospitals

    Newcastle upon Tyne

    Thomas Creasey, thomas.creasey1@nhs.net

    Recruiting

  • Nottingham University Hospitals NHS Trust

    Nottingham, NG5 1PB

    Dean Smith

    Recruiting

  • Cancer and Haematology Centre

    Oxford, OX3 7LE

    Sarah Gooding

    Recruiting

  • University Hospital of Southampton

    Southampton, SO16 6YD

    Andy Davies

    Recruiting

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

    Kamaraj Karunanithi

    Recruiting

  • The Royal Marsden

    Sutton, Surrey, SM2 5PT

    Charlotte Pawlyn

    Recruiting

Other trials in United Kingdom

Spain12 sites, 10 recruiting

  • Hospital Germans Trias i Pujol/ ICO Badalona

    Badalona, 08916

    Albert Oriol-Rocafiguera

    Recruiting

  • University Hospital Vall D'Hebron

    Barcelona, 08035

    Completed

  • Hospital Clínic de Barcelona

    Barcelona, 08036

    Laura Rosiñol Dachs

    Recruiting

  • ICO L'Hospitalet (Instituto Catalán de Oncología)

    Barcelona, 08908

    Anna Sureda Balari

    Recruiting

  • Hospital Universitario de La Princesa

    Madrid, 28006

    Adrian Alegre Amor

    Recruiting

  • Hospital Universitario Gregorio Marañón

    Madrid, 28009

    Cristina Encinas Rodriguez

    Recruiting

  • Hospital Infanta Leonor

    Madrid, 28031

    Jose Angel Hernandez- Rivas

    Recruiting

  • Hospital Universitario Ramón y Cajal

    Madrid, 28034

    María J Blanchard Rodriguez

    Recruiting

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

    Joaquin Martinez-Lopez

    Recruiting

  • CIOCC Hospital Universitario HM Sanchinarro

    Madrid, 28050

    Completed

  • Universidad de Navarra

    Pamplona, 31008

    Paula Rodriguez-Otero

    Recruiting

  • Hospital Universitario y Politécnico La Fe de la Comunidad Valenciana

    Valencia, 46026

    Javier de la Rubia Comos

    Recruiting

Other trials in Spain

United States6 sites, 6 recruiting

  • Emory Winship Cancer Institute

    Atlanta, Georgia, 30322

    Dr Nisha Joseph, MD, 404-778-1900, winship.referrals@emoryhealthcare.org

    Dr Nisha Joseph, MD

    Recruiting

  • The Center for Cancer and Blood Disorders (CCBD)

    Bethesda, Maryland, 20817

    Nejma Louahlia, 301-571-2016, Nejma.louahlia@aoncology.com

    Victor Priego, MD

    Recruiting

  • Community Health Network

    Indianapolis, Indiana, 46227

    Pablo M Bedano, MD, 317-621-4300, pbedano@ecommunity.com

    Pablo M Bedano, MD

    Recruiting

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

    Ashley Servais, 402-955-2691, aservais@nebraskacancer.com

    Stefano Tarantolo, MD

    Recruiting

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198-6846

    Marnee Strege, RN BSN, 402-559-8155, marnee.strege@unmc.edu

    Sarah Holstein, MD

    Recruiting

  • Penn Medicine - Abramson Cancer Center Perelman

    Philadelphia, Pennsylvania, 19104

    Dan Vogl, MD, 215-662-7140, dan.vogl@pennmedicine.upenn.edu

    Dan Vogl, MD

    Recruiting

Other trials in United States

France2 sites

  • Institute Bergonie

    Bordeaux, 33076

    Completed

  • Gustave Roussy

    Villejuif, 94805

    Completed

Other trials in France

Sweden1 site

  • Karolinska Comprehensive Cancer Center

    Stockholm

    Completed

Other trials in Sweden

About this study

Official title: 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.

Read the detailed description

This includes patients with Peripheral T-cell lymphoma.

Medical subject headings
Hematologic Neoplasms, Leukemia, Myeloid, Acute, Lymphoma, Non-Hodgkin, Multiple Myeloma, Lymphoma, T-Cell, Peripheral

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CCS1477Drug

    Oral capsule

  • PomalidomideDrug

    oral capsule

  • DexamethasoneDrug

    oral tablet

  • AzacitidineDrug

    Powder suspension for Injection

  • VenetoclaxDrug

    Oral tablet

  • BortezomibDrug

    Powder for solution for injection

  • IxazomibDrug

    Oral capsule

  • ElranatamabDrug

    Also called Elrexfio

    Solution for injection

  • TeclistamabDrug

    Also called Tecvayli

    Solution for injection

  • LenalidomideDrug

    Oral capsule

  • DaratumumabDrug

    Solution for injection, concentrate for solution for infusion

Study groups in NCT04068597
Study groupRoleWhat they receive
CCS1477 dose escalation NHL/MMExperimentalCCS1477 monotherapy
Receives: Drug: CCS1477
CCS1477 dose escalation AML/Higher risk MDSExperimentalCCS1477 monotherapy
Receives: Drug: CCS1477
CCS1477 monotherapy expansion and combination dose finding and expansion NHLExperimentalCCS1477 monotherapy, CCS1477 combination with lenalidomide
Receives: Drug: CCS1477; Drug: Lenalidomide
CCS1477 monotherapy expansion and combination dose finding and expansion - MMExperimentalCCS1477 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
Receives: Drug: CCS1477; Drug: Pomalidomide; Drug: Dexamethasone; Drug: Bortezomib; Drug: Ixazomib; Drug: Elranatamab; Drug: Teclistamab; Drug: Lenalidomide; Drug: Daratumumab
CCS1477 monotherapy expansion and combination dose finding and expansion - AMLExperimentalCCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax
Receives: Drug: CCS1477; Drug: Azacitidine; Drug: Venetoclax
CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDSExperimentalCCS1477 monotherapy, CCS1477 combination with azacitidine
Receives: Drug: CCS1477; Drug: Azacitidine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of treatment-related adverse events

    Treatment-related adverse events and serious adverse events

    Measured: Up to 12 months

  2. Incidence of laboratory abnormalities

    Laboratory abnormalities characterised by type, frequency, severity and timing

    Measured: Up to 12 months

Secondary outcomes (4)

  1. Response rate

    Defined as number of patients who have a response according to

    • RECIL criteria (NHL)
    • IMWG criteria (Multiple myeloma)
    • ELN recommendations 2017 (AML)

    Measured: Up to 12 months

  2. Duration of Response

    Defined as the time from start of treatment until disease progression

    Measured: Up to 12 months

  3. AUC of CCS1477

    Area under the plasma concentration-time curve (AUC) from time 0 to the time of the last measurable concentration of CCS1477

    Measured: 35 days

  4. Cmax of CCS1477

    Maximum observed plasma concentration (Cmax) of CCS1477

    Measured: 35 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Aug 2019
  2. Study start9 Aug 2019
  3. Primary completion31 Mar 2027 (estimated)
  4. Study completion31 Mar 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
The RP2D/MTD dose will be determined in Parts A and B. Parts C, D, E and F of the study may recruit patients concurrently.
Masking
None (open label)
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04068597
Sponsor's protocol ID
CCS1477-02
Status last verified
Jun 2026
First submitted
12 Aug 2019
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing CCS1477, Pomalidomide and Dexamethasone in people with Haematological Malignancy and Acute Myeloid Leukemia, run by CellCentric Ltd. at 39 sites in 5 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 39 sites in United Kingdom, Spain, United States, France, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tomasz Knurowski, PhD (07882871299, Tomasz.Knurowski@cellcentric.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of treatment-related adverse events (time frame: Up to 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04068597.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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