Cryptococcal MeningitisPhase 3EnACT3NCT05541107
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
A Phase 3 study testing MAT2203 and Amphotericin B in people with Cryptococcal Meningitis, run by Matinas BioPharma Nanotechnologies, Inc..
Trial summary
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cryptococcal Meningitis
- What is being tested?
- MAT2203 and Amphotericin B
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 270 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jan 2025
- Phase
- Phase 3
- 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
- CSF cryptococcal antigen (CrAg) positive meningitis
- Ability and willingness to provide informed consent
- Willing to receive protocol-specified lumbar punctures
Who cannot join
- Glasgow Coma Scale < 15 at time of consent
- Received >= 3 doses of amphotericin B within prior 30 days
- Inability to take enteral (oral or nasogastric) medicine
- Cannot or unlikely to attend regular clinic visits
- Receiving chemotherapy or corticosteroids
- Suspected paradoxical immune reconstitution inflammatory syndrome (IRIS)
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- Pregnancy or breastfeeding
- Previous administration of MAT2203
- Any condition for which participation would not be in the best interest of the participant or that could limit protocol specified assessments
Trial locations and contacts
No sites are listed yet.
About this study
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
Read the detailed description
Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.
- Conditions
- Cryptococcal Meningitis
- Being tested
- MAT2203, Amphotericin B
- Medical subject headings
- Meningitis, Cryptococcal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MAT2203Drug
Also called cAMB
oral lipid nanocrystal amphotericin B
Amphotericin BDrug
Intravenous Amphotericin B
| Study group | Role | What they receive |
|---|---|---|
| MAT2203 Induction / MAT2203 Consolidation | Experimental | 2 days IV Amphotericin B (AMB) + flucytosine (5FC) followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by MAT2203 +fluconazole for 4 weeks of consolidation therapy Receives: Drug: MAT2203 |
| MAT2203 Induction / SOC Consolidation | Experimental | 2 days IV AMB + 5FC followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by 4 weeks of standard of care consolidation therapy Receives: Drug: MAT2203 |
| SOC Induction / SOC Consolidation | Active comparator | Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole) Receives: Drug: Amphotericin B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival
All-cause mortality
Measured: 2 weeks
Secondary outcomes (3)
Meningitis-free survival
Survival time without Cryptococcus culture-positive relapse of meningitis
Measured: 10 weeks
Evidence of fungicidal activity
Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA])
Measured: 2 weeks
CSF culture sterility
cumulative incidence of CSF culture sterilization
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2022
- Study startJan 2023 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionJan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cryptococcal MeningitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 270 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Responsible party
- Sponsor
- Investigators
- David R Boulware, MD, Principal investigator, University of MinnesotaDavid B Meya, MBChB, Principal investigator, Infectious Diseases Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05541107
- Sponsor's protocol ID
- MB-70018
- Other IDs
- CTA 0217
- Acronym
- EnACT3
- Status last verified
- Sep 2022
- First submitted
- 12 Sep 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
- ClinicalTrials.gov ID
- NCT05541107
- Acronym / sponsor ID
- EnACT3 / MB-70018
- Conditions
- Cryptococcal Meningitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 270 participants (estimated)
- Lead sponsor
- Matinas BioPharma Nanotechnologies, Inc.Industry (pharma, biotech, devices)
- Collaborators
- University of Minnesota
- Study start
- Jan 2023 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Jan 2025 (estimated)
- First posted
- 15 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).
Detailed description
Pivotal, prospective, randomized, open-label, non-inferiority trial to compare the efficacy and safety of step-down induction and consolidation therapy for the treatment of cryptococcal meningitis with oral MAT2203 plus flucytosine to standard of care therapy. Randomization will by 1:1:1 to one of two experimental arms or standard of care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MAT2203 Induction / MAT2203 Consolidation | Experimental | Drug: MAT22032 days IV Amphotericin B (AMB) + flucytosine (5FC) followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by MAT2203 +fluconazole for 4 weeks of consolidation therapy |
| MAT2203 Induction / SOC Consolidation | Experimental | Drug: MAT22032 days IV AMB + 5FC followed by oral MAT2203 + 5FC for 12 days of induction therapy followed by 4 weeks of standard of care consolidation therapy |
| SOC Induction / SOC Consolidation | Active comparator | Drug: Amphotericin BStandard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- CSF cryptococcal antigen (CrAg) positive meningitis
- Ability and willingness to provide informed consent
- Willing to receive protocol-specified lumbar punctures
Key exclusion criteria (9 listed)
- Glasgow Coma Scale < 15 at time of consent
- Received >= 3 doses of amphotericin B within prior 30 days
- Inability to take enteral (oral or nasogastric) medicine
- Cannot or unlikely to attend regular clinic visits
- Receiving chemotherapy or corticosteroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MAT2203Also: cAMBoral lipid nanocrystal amphotericin B | Drug | MAT2203 Induction / MAT2203 Consolidation, MAT2203 Induction / SOC Consolidation |
| Amphotericin BIntravenous Amphotericin B | Drug | SOC Induction / SOC Consolidation |
Primary outcome
Survival
Time frame: 2 weeks
All-cause mortality
3 secondary outcomes
Meningitis-free survival
Time frame: 10 weeks
Evidence of fungicidal activity
Time frame: 2 weeks
CSF culture sterility
Time frame: 10 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2022.
- Individual participant dataSharing planned: No
Related trials for Cryptococcal Meningitis
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Etiology, Pathogenesis, and Natural History of Idiopathic CD4+ Lymphocytopenia
Idiopathic CD4+ Lymphocytopenia, Cryptococcal Meningitis
Not yet recruitingPhase 3
Optimizing Care for Cryptococcal Antigenemia: Evaluation of Short Course Fluconazole and ART Timing Among CrAg+ Persons With Low Titers
Cryptococcal Antigenemia, HIV-1-infection
RecruitingPhase 2/3
Platform Trial For Cryptococcal Meningitis (PLATFORM-CM)
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Single Dose Liposomal Amphotericin for Asymptomatic Cryptococcal Antigenemia
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David R Boulware, MD principal investigator
University of Minnesota
David B Meya, MBChB principal investigator
Infectious Diseases Institute
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing MAT2203 and Amphotericin B in people with Cryptococcal Meningitis, run by Matinas BioPharma Nanotechnologies, Inc..
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 3 inclusion and 9 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 15 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Theresa Matkovits, PhD (908-505-0975, tmatkovits@matinasbiopharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Survival (time frame: 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2022.