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Pulmonary FibrosisPhase 1/2MONACONCT04805086

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

A Phase 1/2 study testing MON002 in people with Pulmonary Fibrosis and Interstitial Lung Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
MON002
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5 participants
Where
1 siteUnited Kingdom
Study dates
8 Mar 2021to 5 Mar 2023
Phase
Phase 1/2
Are there results?
None posted in the registry

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

  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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).

Trial locations and contacts

1 site in 1 country.

Ashish Patel, PhD FRCS contact

+442071880214

ashish.patel@kcl.ac.uk

United Kingdom1 site, 1 recruiting

  • Guy's & St Thomas' NHS Foundation Trust

    London, SE1 7EH

    Ashish Patel, PhD FRCS, +442071880214, ashish.patel@kcl.ac.uk

    Bijan Modarai, PhD FRCS, +442071880214, bijan.modarai@kcl.ac.uk

    Recruiting

Other trials in United Kingdom

About this study

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

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.

Read the 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.

Being tested
MON002
Keywords
Phase I/II, cell therapy, ATIMP
Medical subject headings
Pulmonary Fibrosis, Lung Diseases, Interstitial, COVID-19

What participants receive

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

  • MON002Biological

    Autologous monocytes

Study groups in NCT04805086
Study groupRoleWhat they receive
MON002ExperimentalMinimum of 1x10~7 cells to maximum of 2x10~6 cells/kg. Single infusion.
Receives: Biological: MON002

What is being measured

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

  1. 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

    Measured: Total number of SAEs at 12 months after administration

Secondary outcomes (9)

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

    Measured: 3, 6 and 12 months

  2. Rate of decrease in FVC

    Measured: 3, 6 and 12 months

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

    Measured: 3, 6 and 12 months

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

    Measured: 3, 6 and 12 months

  5. 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

    Measured: 3, 6 and 12 months

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

    Measured: 3, 6 and 12 months

  7. 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

    Measured: 3, 6 and 12 months

  8. 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

    Measured: 3, 6 and 12 months

  9. Reduction in fibrosis score on high resolution lung CT

    Measured: 6 and 12 months

Timeline

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

  1. First posted18 Mar 2021
  2. Study start8 Mar 2021 (estimated)
  3. Primary completion1 Jun 2022 (estimated)
  4. Study completion5 Mar 2023 (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
Not applicable
Intervention model
Single group
Model description
Prospective trial
Masking
None (open label)
Enrolment
5 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04805086
Sponsor's protocol ID
289624
Acronym
MONACO
Status last verified
Mar 2021
First submitted
3 Mar 2021
Last updated
18 Mar 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing MON002 in people with Pulmonary Fibrosis and Interstitial Lung Disease, run by Guy's and St Thomas' NHS Foundation Trust at 1 site in United Kingdom.

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 4 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. 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?

Results are not available in the source record.

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

Contact Ashish Patel, PhD FRCS (+442071880214, ashish.patel@kcl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of serious adverse events (SAE) related to the administration of the IMP (time frame: Total number of SAEs at 12 months after administration). 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 NCT04805086.

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 18 Mar 2021.

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