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Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3 (EnACT3)

Primary Purpose

Cryptococcal Meningitis

Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
MAT2203
Amphotericin B
Sponsored by
Matinas BioPharma Nanotechnologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cryptococcal Meningitis

Eligibility Criteria

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

Inclusion Criteria:

  • CSF cryptococcal antigen (CrAg) positive meningitis
  • Ability and willingness to provide informed consent
  • Willing to receive protocol-specified lumbar punctures

Exclusion Criteria:

  • 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)
  • 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    MAT2203 Induction / MAT2203 Consolidation

    MAT2203 Induction / SOC Consolidation

    SOC Induction / SOC Consolidation

    Arm Description

    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

    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

    Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole)

    Outcomes

    Primary Outcome Measures

    Survival
    All-cause mortality

    Secondary Outcome Measures

    Meningitis-free survival
    Survival time without Cryptococcus culture-positive relapse of meningitis
    Evidence of fungicidal activity
    Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA])
    CSF culture sterility
    cumulative incidence of CSF culture sterilization

    Full Information

    First Posted
    September 12, 2022
    Last Updated
    September 12, 2022
    Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Minnesota
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05541107
    Brief Title
    Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
    Acronym
    EnACT3
    Official Title
    Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 2023 (Anticipated)
    Primary Completion Date
    October 2024 (Anticipated)
    Study Completion Date
    January 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Matinas BioPharma Nanotechnologies, Inc.
    Collaborators
    University of Minnesota

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    Yes
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

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

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    270 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    MAT2203 Induction / MAT2203 Consolidation
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    MAT2203 Induction / SOC Consolidation
    Arm Type
    Experimental
    Arm Description
    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
    Arm Title
    SOC Induction / SOC Consolidation
    Arm Type
    Active Comparator
    Arm Description
    Standard of care induction therapy (IV AMB + 5FC) followed by 4 weeks of standard of care consolidation therapy (fluconazole)
    Intervention Type
    Drug
    Intervention Name(s)
    MAT2203
    Other Intervention Name(s)
    cAMB
    Intervention Description
    oral lipid nanocrystal amphotericin B
    Intervention Type
    Drug
    Intervention Name(s)
    Amphotericin B
    Intervention Description
    Intravenous Amphotericin B
    Primary Outcome Measure Information:
    Title
    Survival
    Description
    All-cause mortality
    Time Frame
    2 weeks
    Secondary Outcome Measure Information:
    Title
    Meningitis-free survival
    Description
    Survival time without Cryptococcus culture-positive relapse of meningitis
    Time Frame
    10 weeks
    Title
    Evidence of fungicidal activity
    Description
    Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA])
    Time Frame
    2 weeks
    Title
    CSF culture sterility
    Description
    cumulative incidence of CSF culture sterilization
    Time Frame
    10 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: CSF cryptococcal antigen (CrAg) positive meningitis Ability and willingness to provide informed consent Willing to receive protocol-specified lumbar punctures Exclusion Criteria: 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) 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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Theresa Matkovits, PhD
    Phone
    908-505-0975
    Email
    tmatkovits@matinasbiopharma.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    David R Boulware, MD
    Organizational Affiliation
    University of Minnesota
    Official's Role
    Principal Investigator
    First Name & Middle Initial & Last Name & Degree
    David B Meya, MBChB
    Organizational Affiliation
    Infectious Diseases Institute
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

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