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Study to Evaluate CCS1477 in Haematological Malignancies

Primary Purpose

Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma

Status

Recruiting

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

CCS1477

Pomalidomide

Dexamethasone

Azacitidine

Venetoclax

About this trial

This is an interventional treatment trial for Haematological Malignancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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 (> 480 msec)

Sites / Locations

Mayo Clinic
Institute Bergonie
Institute Gustave Roussy
University Hospital Vall D'HebronRecruiting
CIOCC Hospital Universitario HM SanchinarroRecruiting
Karolinska InstituteRecruiting
The Royal MarsdenRecruiting
University Hospital of WalesRecruiting
Western General HospitalRecruiting
Gartnavel General HospitalRecruiting
Leicester Royal InfirmaryRecruiting
NIHR University College London Clinical Research FacilityRecruiting
The Christie HospitalRecruiting
Cancer and Haematology CentreRecruiting
University Hospital of SouthamptonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Arm Label

CCS1477 dose escalation NHL/MM

CCS1477 dose escalation AML/Higher risk MDS

CCS1477 expansion phase NHL/Peripheral T-cell lymphoma

CCS1477 monotherapy expansion and combination dose finding and expansion - MM

CCS1477 monotherapy expansion and combination dose finding and expansion - AML

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

Arm Description

CCS1477 monotherapy

CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone

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

Outcomes

Primary Outcome Measures

Incidence of treatment-related adverse events

Treatment-related adverse events and serious adverse events

Incidence of laboratory abnormalities

Laboratory abnormalities characterised by type, frequency, severity and timing

Secondary Outcome Measures

Response rate

Defined as number of patients who have a response according to RECIL criteria (NHL) IMWG criteria (Multiple myeloma) ELN recommendations 2017 (AML)

Duration of Response

Defined as the time from start of treatment until disease progression

AUC of CCS1477

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

Cmax of CCS1477

Maximum observed plasma concentration (Cmax) of CCS1477

Full Information

NCT ID

NCT04068597

First Posted

August 12, 2019

Last Updated

October 10, 2023

Sponsor

CellCentric Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT04068597

Brief Title

Study to Evaluate CCS1477 in Haematological Malignancies

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.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2023

Overall Recruitment Status

Recruiting

Study Start Date

August 9, 2019 (Actual)

Primary Completion Date

June 30, 2025 (Anticipated)

Study Completion Date

June 30, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CellCentric Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

A Phase 1/2a study to assess the safety, tolerability, PK and biological activity of CCS1477 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Haematological Malignancy, Acute Myeloid Leukemia, Non Hodgkin Lymphoma, Multiple Myeloma, Higher-risk Myelodysplastic Syndrome, Peripheral T Cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Sequential Assignment

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)

Allocation

Non-Randomized

Enrollment

250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

CCS1477 dose escalation NHL/MM

Arm Type

Experimental

Arm Description

CCS1477 monotherapy

Arm Title

CCS1477 dose escalation AML/Higher risk MDS

Arm Type

Experimental

Arm Description

CCS1477 monotherapy

Arm Title

CCS1477 expansion phase NHL/Peripheral T-cell lymphoma

Arm Type

Experimental

Arm Description

CCS1477 monotherapy

Arm Title

CCS1477 monotherapy expansion and combination dose finding and expansion - MM

Arm Type

Experimental

Arm Description

CCS1477 monotherapy, CCS1477 combination with pomalidomide-dexamethasone

Arm Title

CCS1477 monotherapy expansion and combination dose finding and expansion - AML

Arm Type

Experimental

Arm Description

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

Arm Title

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

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

CCS1477

Intervention Description

Oral capsule

Intervention Type

Drug

Intervention Name(s)

Pomalidomide

Intervention Description

oral capsule

Intervention Type

Drug

Intervention Name(s)

Dexamethasone

Intervention Description

oral tablet

Intervention Type

Drug

Intervention Name(s)

Azacitidine

Intervention Description

Powder suspension for Injection

Intervention Type

Drug

Intervention Name(s)

Venetoclax

Intervention Description

Oral tablet

Primary Outcome Measure Information:

Title

Incidence of treatment-related adverse events

Description

Treatment-related adverse events and serious adverse events

Time Frame

Up to 12 months

Title

Incidence of laboratory abnormalities

Description

Laboratory abnormalities characterised by type, frequency, severity and timing

Time Frame

Up to 12 months

Secondary Outcome Measure Information:

Title

Response rate

Description

Defined as number of patients who have a response according to RECIL criteria (NHL) IMWG criteria (Multiple myeloma) ELN recommendations 2017 (AML)

Time Frame

Up to 12 months

Title

Duration of Response

Description

Defined as the time from start of treatment until disease progression

Time Frame

Up to 12 months

Title

AUC of CCS1477

Description

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

Time Frame

35 days

Title

Cmax of CCS1477

Description

Maximum observed plasma concentration (Cmax) of CCS1477

Time Frame

35 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 (> 480 msec)

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Tomasz Knurowski, PhD

Phone

07882871299

Tomasz.Knurowski@cellcentric.com

First Name & Middle Initial & Last Name or Official Title & Degree

Karen Clegg, MD, MFPM

Karen.Clegg@cellcentric.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Tim Somervaille

Organizational Affiliation

The Christie NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85054

Country

United States

Individual Site Status

Withdrawn

Facility Name

Institute Bergonie

City

Bordeaux

ZIP/Postal Code

33000

Country

France

Individual Site Status

Withdrawn

Facility Name

Institute Gustave Roussy

City

Villejuif

ZIP/Postal Code

94805

Country

France

Individual Site Status

Active, not recruiting

Facility Name

University Hospital Vall D'Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

David Valcárcel Ferreiras

Facility Name

CIOCC Hospital Universitario HM Sanchinarro

City

Madrid

ZIP/Postal Code

28050

Country

Spain

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jaime Perez de Oteyza

Facility Name

Karolinska Institute

City

Stockholm

ZIP/Postal Code

171 76

Country

Sweden

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Maria Creignou

Facility Name

The Royal Marsden

City

Sutton

State/Province

Surrey

ZIP/Postal Code

SM2 5PT

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Dima El-Sharkawi

Facility Name

University Hospital of Wales

City

Cardiff

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Steven Knapper

Facility Name

Western General Hospital

City

Edinburgh

ZIP/Postal Code

EH4 2XU

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Victoria Campbell

Facility Name

Gartnavel General Hospital

City

Glasgow

ZIP/Postal Code

G12 0YN

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mhairi Copland

Facility Name

Leicester Royal Infirmary

City

Leicester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Harriet Walter

Facility Name

NIHR University College London Clinical Research Facility

City

London

ZIP/Postal Code

W1T 7HA

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jenny O'Nions

Facility Name

The Christie Hospital

City

Manchester

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Tim Somervaille

Facility Name

Cancer and Haematology Centre

City

Oxford

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Paresh Vyas

Facility Name

University Hospital of Southampton

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Andy Davies

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing 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.

Learn more about this trial

Study to Evaluate CCS1477 in Haematological Malignancies

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