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.
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
- Conditions the study is for
- Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma
- What is being tested?
- CCS1477, Pomalidomide and Dexamethasone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- 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
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
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- 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.
Karen Clegg, MD, MFPM contact
39 sites in 5 countries
United Kingdom18 sites, 18 recruiting
- 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
Spain12 sites, 10 recruiting
- Recruiting
Hospital Germans Trias i Pujol/ ICO Badalona
Badalona, 08916
Albert Oriol-Rocafiguera
- Completed
University Hospital Vall D'Hebron
Barcelona, 08035
- Recruiting
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
- Completed
CIOCC Hospital Universitario HM Sanchinarro
Madrid, 28050
- Recruiting
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
United States6 sites, 6 recruiting
- 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
France2 sites
- Completed
Institute Bergonie
Bordeaux, 33076
- Completed
Gustave Roussy
Villejuif, 94805
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.
- Conditions
- Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma
- Being tested
- CCS1477, Pomalidomide, Dexamethasone, Azacitidine, Venetoclax
- 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 group | Role | What they receive |
|---|---|---|
| CCS1477 dose escalation NHL/MM | Experimental | CCS1477 monotherapy Receives: Drug: CCS1477 |
| CCS1477 dose escalation AML/Higher risk MDS | Experimental | CCS1477 monotherapy Receives: Drug: CCS1477 |
| CCS1477 monotherapy expansion and combination dose finding and expansion NHL | Experimental | CCS1477 monotherapy, CCS1477 combination with lenalidomide Receives: Drug: CCS1477; Drug: Lenalidomide |
| CCS1477 monotherapy expansion and combination dose finding and expansion - MM | Experimental | 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 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 - AML | Experimental | CCS1477 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 MDS | Experimental | CCS1477 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.
Incidence of treatment-related adverse events
Treatment-related adverse events and serious adverse events
Measured: Up to 12 months
Incidence of laboratory abnormalities
Laboratory abnormalities characterised by type, frequency, severity and timing
Measured: Up to 12 months
Secondary outcomes (4)
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
Duration of Response
Defined as the time from start of treatment until disease progression
Measured: Up to 12 months
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
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.
- First posted28 Aug 2019
- Study start9 Aug 2019
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- CellCentric Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tim Somervaille, Principal investigator, The Christie NHS Foundation Trust
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.