Recruiting

Phase 1

Phase 2

CCS1477Study to Evaluate CCS1477 (Inobrodib) in Haematological Malignancies

Sponsor:

CellCentric Ltd.

Code:

NCT04068597

Conditions

Haematological Malignancy

Acute Myeloid Leukemia

Non Hodgkin Lymphoma

Multiple Myeloma

Higher-risk Myelodysplastic Syndrome

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CCS1477

Pomalidomide

Dexamethasone

Azacitidine

Venetoclax

Study Details

Brief 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.

Conditions

Haematological Malignancy

Acute Myeloid Leukemia

Non Hodgkin Lymphoma

Multiple Myeloma

Higher-risk Myelodysplastic Syndrome

Study ID

NCT04068597

Start date

Aug 9, 2019

Status verified date

Jun, 2026

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

250 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: CCS1477 dose escalation NHL/MM

CCS1477 monotherapy

experimental: CCS1477 dose escalation AML/Higher risk MDS

CCS1477 monotherapy

experimental: CCS1477 monotherapy expansion and combination dose finding and expansion NHL

CCS1477 monotherapy, CCS1477 combination with lenalidomide

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

experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - AML

CCS1477 monotherapy, CCS1477 combination with azacitidine, CCS1477 combination with azacitidine and venetoclax

experimental: CCS1477 monotherapy expansion and combination dose finding and expansion - Higher risk MDS

CCS1477 monotherapy, CCS1477 combination with azacitidine

Interventions

CCS1477

Oral capsule

Pomalidomide

oral capsule

Dexamethasone

oral tablet

Azacitidine

Powder suspension for Injection

Venetoclax

Oral tablet

Bortezomib

Powder for solution for injection

Ixazomib

Oral capsule

Elranatamab

Solution for injection

Teclistamab

Solution for injection

Lenalidomide

Oral capsule

Daratumumab

Solution for injection, concentrate for solution for infusion

Primary outcome measure

Incidence of treatment-related adverse events [ Time Frame: Up to 12 months ]
Incidence of laboratory abnormalities [ Time Frame: Up to 12 months ]

Central Contacts and Locations

Central contacts

Tomasz Knurowski, PhD

07882871299 Tomasz.Knurowski@cellcentric.com

Karen Clegg, MD, MFPM

Karen.Clegg@cellcentric.com

Locations

Emory Winship Cancer Institute

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Dr Nisha Joseph, MD

404-778-1900 winship.referrals@emoryhealthcare.org

Principal Investigator:

Dr Nisha Joseph, MD

Community Health Network

Recruiting

Indianapolis, Indiana, United States, 46227

Contacts

Pablo M Bedano, MD

317-621-4300 pbedano@ecommunity.com

Principal Investigator:

Pablo M Bedano, MD

The Center for Cancer and Blood Disorders (CCBD)

Recruiting

Bethesda, Maryland, United States, 20817

Contacts

Nejma Louahlia

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

Principal Investigator:

Victor Priego, MD

Nebraska Cancer Specialists

Recruiting

Omaha, Nebraska, United States, 68130

Contacts

Ashley Servais

402-955-2691 aservais@nebraskacancer.com

Principal Investigator:

Stefano Tarantolo, MD

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-6846

Contacts

Marnee Strege, RN BSN

402-559-8155 marnee.strege@unmc.edu

Principal Investigator:

Sarah Holstein, MD

Penn Medicine - Abramson Cancer Center Perelman

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Dan Vogl, MD

215-662-7140 dan.vogl@pennmedicine.upenn.edu

Principal Investigator:

Dan Vogl, MD

More Information

Sponsor

CellCentric Ltd.

Last update posted

Jun 24, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by CellCentric Ltd. on 2026-06-24.