Encochleated Oral Amphotericin for Cryptococcal Meningitis Trial 3

NCT05541107 | Unknown Phase 3 DMC FDA Drug

• 2 other identifiers: MB-70018CTA 0217
• Study Type: interventional
• Target: 270
• Locations: 0 countries
• Sites: N/A

Brief Summary

This pivotal, confirmatory trial seeks to independently verify the results observed in the EnACT Phase II Stage 2 trial (MB-70007).

Conditions

Cryptococcal Meningitis

Outcome Measures

Primary Outcomes (1)

• Survival

  All-cause mortality

  2 weeks

Secondary Outcomes (3)

• Meningitis-free survival

  10 weeks

• Evidence of fungicidal activity

  2 weeks

• CSF culture sterility

  10 weeks

Study Arms (3)

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

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

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)

Drug: Amphotericin B

Interventions

MAT2203 DRUG

oral lipid nanocrystal amphotericin B

Also known as: cAMB

MAT2203 Induction / MAT2203 Consolidation; MAT2203 Induction / SOC Consolidation

Amphotericin B DRUG

Intravenous Amphotericin B

SOC Induction / SOC Consolidation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Matinas BioPharma Nanotechnologies, Inc.: lead
• University of Minnesota: collaborator

MeSH Terms

Conditions

Meningitis, Cryptococcal

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Meningitis, Fungal; Central Nervous System Fungal Infections; Mycoses; Bacterial Infections and Mycoses; Infections; Cryptococcosis; Central Nervous System Infections; Central Nervous System Diseases; Nervous System Diseases; Meningitis; Neuroinflammatory Diseases

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• David R Boulware, MD

  University of Minnesota

  PRINCIPAL INVESTIGATOR

• David B Meya, MBChB

  Infectious Diseases Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Theresa Matkovits, PhD

CONTACT

908-505-0975; tmatkovits@matinasbiopharma.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2022
• First Posted: September 15, 2022
• Study Start: January 1, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: September 15, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share