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The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19 (MONACO)

Primary Purpose

Pulmonary Fibrosis, Interstitial Lung Disease, Covid19

Status

Unknown status

Phase

Phase 1

Locations

United Kingdom

Study Type

Interventional

Intervention

MON002

About this trial

This is an interventional treatment trial for Pulmonary Fibrosis focused on measuring Phase I/II, cell therapy, ATIMP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Clinical evidence/diagnosis of interstitial lung disease (fibrosis) following COVID-19 infection
Aged at least 18 years
Willing and able to participate in the MONACO Cell Therapy Study
Signed and dated written informed consent.

Exclusion Criteria:

Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase.
Malignant or premalignant haematological conditions
Serologically positive for antiHIV1,2; HBsAg; Anti-HBc; Anti-HCVab;Anti-HTLV1,2 or syphilis (Treponema palladium)
Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully treated non metastatic basal/squamous cell carcinoma of the skin)
Evidence of significant local or systemic infection
Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives
Clinical diagnosis of interstitial lung disease prior to the COVID-19 infection
Any condition which, in the judgement of the Investigator, would place the subject at undue risk
Female patients of childbearing potential with a positive serum pregnancy test at enrolment
Sexually active Women of Childbearing Potential who do not agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 4 weeks post IMP administration. Men who do not agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy after receiving the therapy
Female patients who are breastfeeding
Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow up visit schedule
Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel
Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Sites / Locations

Guy's & St Thomas' NHS Foundation TrustRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MON002

Arm Description

Minimum of 1x10~7 cells to maximum of 2x10~6 cells/kg. Single infusion.

Outcomes

Primary Outcome Measures

Frequency of serious adverse events (SAE) related to the administration of the IMP

Any SAEs that result in death, are life-threatening, require hospitalisation or prolonged or existing hospitalisation (that are not determined to be as a result of disease progression) or result in persistent or significant disability or incapacity

Secondary Outcome Measures

Absolute change from baseline of predicted forced vital capacity (FVC)

Rate of decrease in FVC

Time to first occurrence of a ≥10% absolute decline in percentage of predicted FVC

Time to decrease from baseline (relative change) of ≥ 10% in FVC (mL/year)

Time from cell administration to first event of acute pulmonary fibrosis exacerbation

Defined by (a) worsening or development of dyspnoea and radiologic evidence of new bilateral ground-glass abnormality or consolidation superimposed on a reticular or honeycomb background pattern

Absolute change in transfer capacity of the lung (TLCO).

Improvement in quality of life as indicated by the King's Brief Interstitial Lung Disease (K-BILD) score

Score is transformed to range from 0-100. 100=best health status

Improvement in quality of life as indicated by the 36-Item Short Form Survey (SF-36) score

Score is transformed to range from 0-100. 100=best health status

Reduction in fibrosis score on high resolution lung CT

Full Information

NCT ID

NCT04805086

First Posted

March 3, 2021

Last Updated

March 17, 2021

Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

1. Study Identification

Unique Protocol Identification Number

NCT04805086

Brief Title

The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

Acronym

MONACO

Official Title

Phase I/II MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

Study Type

Interventional

2. Study Status

Record Verification Date

March 2021

Overall Recruitment Status

Unknown status

Study Start Date

March 8, 2021 (Anticipated)

Primary Completion Date

June 1, 2022 (Anticipated)

Study Completion Date

March 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Guy's and St Thomas' NHS Foundation Trust

Collaborators

King's College London

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Up to a third of patients who recovered from SARS coronavirus (SARS-CoV) had a 20% decline in lung function with a long term reduction in exercise capacity and SF-36 health status a year after infection. Similar outcomes are now being reported in COVID-19 patients, with interstitial lung disease (fibrosis) and long term lung function decline being a common feature. Anti-fibrotic monocytes/macrophages are important for the clearance of partially degraded collagen fragments of fibrotic extracellular matrix, in particular fibrillary-type collagen. MON002 is an autologous monocyte product, cultured in vitro prior to intravenous delivery into patients with post-COVID-19 lung fibrosis.

Detailed Description

The MONACO Cell Therapy Study is a prospective, non-randomised, open label study phase I/II clinical trial with a key objective of evaluating safety of MON002 in 5 adults who have a clinical diagnosis of interstitial lung disease (pulmonary fibrosis) after recovery from acute COVID-19 infection. The main objectives of this study are to: (1) to determine the safety profile of MON002 by assessing clinical responses in adults with post-COVID-19 pulmonary fibrosis and (2) to assess its impact on reducing disease morbidity/severity in this population.

6. Conditions and Keywords

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

Pulmonary Fibrosis, Interstitial Lung Disease, Covid19

Keywords

Phase I/II, cell therapy, ATIMP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Prospective trial

Masking

None (Open Label)

Allocation

N/A

Enrollment

5 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

MON002

Arm Type

Experimental

Arm Description

Minimum of 1x10~7 cells to maximum of 2x10~6 cells/kg. Single infusion.

Intervention Type

Biological

Intervention Name(s)

MON002

Intervention Description

Autologous monocytes

Primary Outcome Measure Information:

Title

Frequency of serious adverse events (SAE) related to the administration of the IMP

Description

Time Frame

Total number of SAEs at 12 months after administration

Secondary Outcome Measure Information:

Title

Absolute change from baseline of predicted forced vital capacity (FVC)

Time Frame

3, 6 and 12 months

Title

Rate of decrease in FVC

Time Frame

3, 6 and 12 months

Title

Time to first occurrence of a ≥10% absolute decline in percentage of predicted FVC

Time Frame

3, 6 and 12 months

Title

Time to decrease from baseline (relative change) of ≥ 10% in FVC (mL/year)

Time Frame

3, 6 and 12 months

Title

Time from cell administration to first event of acute pulmonary fibrosis exacerbation

Description

Defined by (a) worsening or development of dyspnoea and radiologic evidence of new bilateral ground-glass abnormality or consolidation superimposed on a reticular or honeycomb background pattern

Time Frame

3, 6 and 12 months

Title

Absolute change in transfer capacity of the lung (TLCO).

Time Frame

3, 6 and 12 months

Title

Improvement in quality of life as indicated by the King's Brief Interstitial Lung Disease (K-BILD) score

Description

Score is transformed to range from 0-100. 100=best health status

Time Frame

3, 6 and 12 months

Title

Improvement in quality of life as indicated by the 36-Item Short Form Survey (SF-36) score

Description

Score is transformed to range from 0-100. 100=best health status

Time Frame

3, 6 and 12 months

Title

Reduction in fibrosis score on high resolution lung CT

Time Frame

6 and 12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Clinical evidence/diagnosis of interstitial lung disease (fibrosis) following COVID-19 infection Aged at least 18 years Willing and able to participate in the MONACO Cell Therapy Study Signed and dated written informed consent. Exclusion Criteria: Subjects who have had other investigational medicinal products within 90 days prior to screening or during the treatment phase. Malignant or premalignant haematological conditions Serologically positive for antiHIV1,2; HBsAg; Anti-HBc; Anti-HCVab;Anti-HTLV1,2 or syphilis (Treponema palladium) Concomitant malignancy or history of malignancy within 5 years prior to planned study entry (excluding successfully treated non metastatic basal/squamous cell carcinoma of the skin) Evidence of significant local or systemic infection Any uncontrolled medical condition or concurrent disease that could interfere with the study objectives Clinical diagnosis of interstitial lung disease prior to the COVID-19 infection Any condition which, in the judgement of the Investigator, would place the subject at undue risk Female patients of childbearing potential with a positive serum pregnancy test at enrolment Sexually active Women of Childbearing Potential who do not agree continued abstinence from heterosexual intercourse or to use highly effective methods of birth control for the duration up to 4 weeks post IMP administration. Men who do not agree to use a condom if their partner is of child bearing potential, even if they have had a successful vasectomy after receiving the therapy Female patients who are breastfeeding Psychological, familial, sociological or geographical factors potentially hampering compliance with the study protocol and follow up visit schedule Any form of substance abuse, psychiatric disorder, or other condition that, in the opinion of the Investigator, may invalidate communication with the Investigator and/or designated study personnel Patients unable to freely give their informed consent (e.g. individuals under legal guardianship).

Central Contact Person:

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

Ashish Patel, PhD FRCS

Phone

+442071880214

ashish.patel@kcl.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ashish Patel, PhD FRCS

Organizational Affiliation

King's College London and Guy's & St Thomas' NHS Foundation Trust

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Bijan Modarai, PhD FRCS

Organizational Affiliation

King's College London and Guy's & St Thomas' NHS Foundation Trust

Official's Role

Principal Investigator

Facility Information:

Facility Name

Guy's & St Thomas' NHS Foundation Trust

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ashish Patel, PhD FRCS

Phone

+442071880214

ashish.patel@kcl.ac.uk

First Name & Middle Initial & Last Name & Degree

Bijan Modarai, PhD FRCS

Phone

+442071880214

bijan.modarai@kcl.ac.uk

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

The MONACO Cell Therapy Study: Monocytes as an Anti-fibrotic Treatment After COVID-19

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