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EnACT3: Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

Sponsor
Matinas BioPharma Nanotechnologies, Inc. (Industry)
Overall Status
Not yet recruiting
CT.gov ID
NCT05541107
Collaborator
University of Minnesota (Other)
270
Enrollment
3
Arms
24
Anticipated Duration (Months)

Study Details

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).

Condition or Disease Intervention/Treatment Phase
Phase 3

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

Study Type:
Interventional
Anticipated Enrollment :
270 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Oct 1, 2024
Anticipated Study Completion Date :
Jan 1, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: MAT2203 Induction / MAT2203 Consolidation

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

Drug: MAT2203
oral lipid nanocrystal amphotericin B
Other Names:
  • cAMB

    		•
    Experimental: MAT2203 Induction / SOC Consolidation

    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

    Drug: MAT2203
    oral lipid nanocrystal amphotericin B
    Other Names:
  • cAMB

    		•
    Active Comparator: SOC Induction / SOC Consolidation

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

    Drug: Amphotericin B
    Intravenous Amphotericin B

    Outcome Measures

    Primary Outcome Measures

    1. Survival [2 weeks]

      All-cause mortality

    Secondary Outcome Measures

    1. Meningitis-free survival [10 weeks]

      Survival time without Cryptococcus culture-positive relapse of meningitis

    2. Evidence of fungicidal activity [2 weeks]

      Rate of CSF Cryptococcus clearance (early fungicidal activity [EFA])

    3. CSF culture sterility [10 weeks]

      cumulative incidence of CSF culture sterilization

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Matinas BioPharma Nanotechnologies, Inc.
    • University of Minnesota

    Investigators

    • Principal Investigator: David R Boulware, MD, University of Minnesota
    • Principal Investigator: David B Meya, MBChB, Infectious Diseases Institute

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Matinas BioPharma Nanotechnologies, Inc.
    ClinicalTrials.gov Identifier:
    NCT05541107
    Other Study ID Numbers:
    • MB-70018
    • CTA 0217
    First Posted:
    Sep 15, 2022
    Last Update Posted:
    Sep 15, 2022
    Last Verified:
    Sep 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Meningitis, Cryptococcal
    Meningitis
    Amphotericin B
    Liposomal amphotericin B

    Study Results

    No Results Posted as of Sep 15, 2022