MalariaPhase 2NCT06040346
Open-Label Study to Assess Meplazumab in Adult Patients Diagnosed with Plasmodium Falciparum
A Phase 2 study testing Meplazumab for Injection in people with Malaria, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 1 site in Kenya.
Trial summary
This phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Malaria
- What is being tested?
- Meplazumab for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteKenya
- Study dates
- 26 Apr 2024to 9 Oct 2025
- Phase
- Phase 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ability to provide informed consent signed by the study participant or legally authorized representative
- Adults 18 to 55 years at the time of signing the informed consent form (ICF)
- Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP), as defined in Section 10.4.
- Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Section 10.4.
- BMI ≥18 to ≤30 kg/m2
- Mono-infection with P. falciparum documented by:
- Microscopically confirmed parasite infection using by Giemsa-stained thick film (refer to the laboratory manual for details) consisting of 1000 - 100,000 asexual parasites /µL of blood and
- Documented fever (≥38.0°C oral, rectal or tympanic; ≥37.5°C axillary) or documented history of fever in previous 24 hours
Who cannot join
- Presence of severe malaria (as defined by World Health Organization Guidelines for Malaria 16 February 2021).
- Severe falciparum malaria is defined as one or more of the following, occurring in the absence of an identified alternative cause and in the presence of P. falciparum asexual parasitemia.
- Impaired consciousness: A Glasgow coma score <11 in adults
- Prostration: Generalized weakness so that the person is unable to sit, stand or walk without assistance
- Multiple convulsions: More than 2 episodes within 24 h
- Acidosis: A base deficit of >8 mEq/L or, if not available, a plasma bicarbonate level of <15 mmol/L or venous plasma lactate ≥5 mmol/L. Severe acidosis manifests clinically as respiratory distress (rapid, deep, labored breathing).
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- Hypoglycemia: Blood or plasma glucose <2.2 mmol/L (<40 mg/dL)
- Severe malarial anemia: Hemoglobin concentration ≤7 g/dL or a hematocrit of ≤20% in adults with a parasite count >10,000/μL
- Renal impairment: Plasma or serum creatinine >265 μmol/L (3 mg/dL) or blood urea >20 mmol/L
- Jaundice: Plasma or serum bilirubin >50 μmol/L (3 mg/dL) with a parasite count >100,000/ μL
- Pulmonary edema: Radiologically confirmed or oxygen saturation <92% on room air with a respiratory rate >30/min, often with chest indrawing and crepitations on auscultation
- Significant bleeding: Including recurrent or prolonged bleeding from the nose, gums or venepuncture sites; hematemesis or melena
- Shock: Compensated shock is defined as capillary refill ≥3 s or temperature gradient on leg (mid to proximal limb), but no hypotension. Decompensated shock is defined as systolic blood pressure <80 mmHg in adults, with evidence of impaired perfusion (cool peripheries or prolonged capillary refill).
- Hyperparasitemia: P. falciparum parasitemia >10%
- Antimalarial treatment (alone or in combination) during the following periods before Screening:
- Piperaquine, mefloquine, naphthoquine or sulfadoxine-pyrimethamine within 6 weeks prior to Screening.
- Amodiaquine, chloroquine within 4 weeks prior to Screening.
- Any artemisinin derivative (artesunate, artemether or dihydroartemisinin), quinine, lumefantrine or any other antimalarial treatment or antibiotic with antimalarial activity (including cotrimoxazole, tetracyclines, quinolones and fluoroquinolones and azithromycin) within 14 days prior to Screening.
- Any herbal products or traditional medicines, within the past 7 days.
- Previous participation in any malaria vaccine study or received malaria vaccine within 3 months of Screening Visit.
- Known allergy to any study medication, including allergy to any component of protocol prescribed rescue treatment i.e., country-specific ACT regimen.
- Any clinically important illness, including but not limited to a history of clinically significant chronic respiratory disease (eg, chronic obstructive pulmonary disease [COPD] or asthma), medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product.
- Participants participate in another clinical study. There will be a need for washout with 5 half-lives depending on the study treatment or 30 days, whichever is longer.
- Use of anti-cancer, anti-transplant rejection, or immunomodulatory biological drug or kinase inhibitor (e.g., tocilizumab, sarilumab) or Janus kinase inhibitors (within 30 days of enrollment or 5 times the half-life [whichever is longer]).
- Chronic corticosteroids use equivalent to daily oral prednisone >10 mg per day (10 mg oral prednisone every other day is allowed).
- Live (live-attenuated) vaccines are not permitted within 2 weeks prior to study treatment or during the study treatment and safety follow-up periods.
- Presence of Hepatitis A IgM, Hepatitis B surface antigen, or Hepatitis C antibody.
- TBL >1.5 × ULN, ALT >2 × ULN, or AST >2 × ULN.
- Hematocrit <20%, hemoglobin <70 g/L (<7 g/dL), or white blood count >15,000/μL.
- Creatinine >1.5 × ULN.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2a, Multicenter, Open-label, Dose-finding, Dose Escalation Study of Meplazumab in Adult Patients Diagnosed with Uncomplicated Plasmodium Falciparum Malaria
This phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum
Read the detailed description
Rationale:
Meplazumab, an erythrocytic stage-macromolecular antibody drug, has the potential to control clinical occurrence of falciparum malaria. Meplazumab is a humanized anti-CD147 immunoglobulin G subclass 2 (IgG2) monoclonal antibody with strong affinity to CD147. CD147 is expressed on erythrocyte lineage cells throughout erythroid development, including mature erythrocytes and is the target for Plasmodium merozoites to allow reorientation and subsequent invasion of the erythrocytes. Nonclinical studies have demonstrated that meplazumab binding to CD147 interferes with the receptor-ligand interaction between CD147 and rhoptry-associated protein 2 (RAP2) of the P. falciparum merozoite and inhibits the formation of parasitophorous vacuoles of P. falciparum thus preventing the invasion of P. falciparum into human erythrocytes. Furthermore, the therapeutic and prophylactic effects of meplazumab were demonstrated in vivo using a human erythrocyte chimeric NOG mouse model, which is considered as an optimal choice for in vivo inhibition efficacy study for human-hosted P. falciparum.
Meplazumab has previously been studied in healthy participants in two Phase 1 studies and has also been evaluated for activity in 2 completed clinical trials in patients diagnosed with coronavirus disease 2019 (COVID 19). In the safety, tolerability, and pharmacokinetics study in healthy participants, MPZ I-01, results demonstrated a high and prolonged receptor occupancy (RO%) of meplazumab at CD147.
This Phase 2a study is designed as a dose escalation trial to assess safety of meplazumab in the target population and to evaluate whether meplazumab is efficacious in treating malaria. The data obtained in this study will be used to determine a recommended meplazumab dose for future Phase 2b and 3 efficacy trials.
Overall Design:
This is a Phase 2a multicenter, open-label, dose-finding, dose escalation study. The study will recruit participants with confirmed P. falciparum infection. Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants /dose level).
Number of Participants:
Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants/dose level).
Intervention Groups and Duration:
Participants will be administered a single intravenous (IV) infusion dose of meplazumab 120±5 minutes on Day 0 and confined for 72 hours after dosing (up to Day 3) to monitor for safety and tolerability of therapy, and to ensure treatment response. During confinement, blood sampling for safety, pharmacokinetic (PK), and RO pharmacodynamic (PD) testing at predefined times will be collected as specified per the Schedule of Assessment (SoA). Furthermore, in a subset of 10 participants/dose level, additional (serial) PK and PD sample will be collected at 1, 2, 4 and 8 hours post end-of-infusion. Up to 3 additional samples may be added to the Day 0-3 serial sample collection period.
If clinically well, participants may be discharged from the clinical unit on Day 3 at the Investigator's discretion. Participants will return to the study center for follow-up visits on Days 28±2, 56±7, 84±7 and 182±7 (End of Study) for safety, tolerability, PK, PD (RO rate), and immunogenicity assessments as per the SoA (Weeks 4, 8, 12 and 26).
- Conditions
- Malaria
- Being tested
- Meplazumab for Injection
- Medical subject headings
- Malaria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meplazumab for InjectionDrug
Meplazumab, an erythrocytic stage-macromolecular antibody drug, has the potential to control clinical occurrence of falciparum malaria. Meplazumab is a humanized anti-CD147 immunoglobulin G subclass 2 (IgG2) monoclonal antibody with strong affinity to CD147. CD147 is expressed on erythrocyte lineage cells throughout erythroid development, including mature erythrocytes and is the target for Plasmodium merozoites to allow reorientation and subsequent invasion of the erythrocytes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Groups | Experimental | Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants/dose level). Receives: Drug: Meplazumab for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of participants with Drug-related SAE, All-cause SAE, Drug-related AESI, All-cause AESI.
To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection
Measured: up to 26 weeks
The Number of Participants discontinuation/ withdrawals due to AE
To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection
Measured: up to 26 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 2023
- Study start26 Apr 2024
- Primary completionAug 2025 (estimated)
- Study completion9 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalariaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06040346
- Sponsor's protocol ID
- MPZ-MAL-01
- Status last verified
- Oct 2024
- First submitted
- 8 Sep 2023
- Last updated
- 29 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2a, Multicenter, Open-label, Dose-finding, Dose Escalation Study of Meplazumab in Adult Patients Diagnosed with Uncomplicated Plasmodium Falciparum Malaria
- ClinicalTrials.gov ID
- NCT06040346
- Acronym / sponsor ID
- MPZ-MAL-01
- Conditions
- Malaria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Jiangsu Pacific Meinuoke Bio Pharmaceutical Co LtdIndustry (pharma, biotech, devices)
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- 9 Oct 2025 (estimated)
- First posted
- 15 Sep 2023 (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 phase 2a open-label study to assess Meplazumab in adult patients diagnosed with Plasmodium falciparum
Detailed description
Rationale:
Meplazumab, an erythrocytic stage-macromolecular antibody drug, has the potential to control clinical occurrence of falciparum malaria. Meplazumab is a humanized anti-CD147 immunoglobulin G subclass 2 (IgG2) monoclonal antibody with strong affinity to CD147. CD147 is expressed on erythrocyte lineage cells throughout erythroid development, including mature erythrocytes and is the target for Plasmodium merozoites to allow reorientation and subsequent invasion of the erythrocytes. Nonclinical studies have demonstrated that meplazumab binding to CD147 interferes with the receptor-ligand interaction between CD147 and rhoptry-associated protein 2 (RAP2) of the P. falciparum merozoite and inhibits the formation of parasitophorous vacuoles of P. falciparum thus preventing the invasion of P. falciparum into human erythrocytes. Furthermore, the therapeutic and prophylactic effects of meplazumab were demonstrated in vivo using a human erythrocyte chimeric NOG mouse model, which is considered as an optimal choice for in vivo inhibition efficacy study for human-hosted P. falciparum.
Meplazumab has previously been studied in healthy participants in two Phase 1 studies and has also been evaluated for activity in 2 completed clinical trials in patients diagnosed with coronavirus disease 2019 (COVID 19). In the safety, tolerability, and pharmacokinetics study in healthy participants, MPZ I-01, results demonstrated a high and prolonged receptor occupancy (RO%) of meplazumab at CD147.
This Phase 2a study is designed as a dose escalation trial to assess safety of meplazumab in the target population and to evaluate whether meplazumab is efficacious in treating malaria. The data obtained in this study will be used to determine a recommended meplazumab dose for future Phase 2b and 3 efficacy trials.
Overall Design:
This is a Phase 2a multicenter, open-label, dose-finding, dose escalation study. The study will recruit participants with confirmed P. falciparum infection. Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants /dose level).
Number of Participants:
Up to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants/dose level).
Intervention Groups and Duration:
Participants will be administered a single intravenous (IV) infusion dose of meplazumab 120±5 minutes on Day 0 and confined for 72 hours after dosing (up to Day 3) to monitor for safety and tolerability of therapy, and to ensure treatment response. During confinement, blood sampling for safety, pharmacokinetic (PK), and RO pharmacodynamic (PD) testing at predefined times will be collected as specified per the Schedule of Assessment (SoA). Furthermore, in a subset of 10 participants/dose level, additional (serial) PK and PD sample will be collected at 1, 2, 4 and 8 hours post end-of-infusion. Up to 3 additional samples may be added to the Day 0-3 serial sample collection period.
If clinically well, participants may be discharged from the clinical unit on Day 3 at the Investigator's discretion. Participants will return to the study center for follow-up visits on Days 28±2, 56±7, 84±7 and 182±7 (End of Study) for safety, tolerability, PK, PD (RO rate), and immunogenicity assessments as per the SoA (Weeks 4, 8, 12 and 26).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention Groups | Experimental | Drug: Meplazumab for InjectionUp to 60 participants will be enrolled into 1 of 3 meplazumab dose levels (20 participants/dose level). |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Ability to provide informed consent signed by the study participant or legally authorized representative
- Adults 18 to 55 years at the time of signing the informed consent form (ICF)
- Female participants are eligible to participate if they do not qualify as a woman of childbearing potential (WOCBP), as defined in Section 10.4.
- Male participants who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in Section 10.4.
- BMI ≥18 to ≤30 kg/m2
Key exclusion criteria (30 listed)
- Presence of severe malaria (as defined by World Health Organization Guidelines for Malaria 16 February 2021).
- Antimalarial treatment (alone or in combination) during the following periods before Screening:
- Previous participation in any malaria vaccine study or received malaria vaccine within 3 months of Screening Visit.
- Known allergy to any study medication, including allergy to any component of protocol prescribed rescue treatment i.e., country-specific ACT regimen.
- Any clinically important illness, including but not limited to a history of clinically significant chronic respiratory disease (eg, chronic obstructive pulmonary disease [COPD] or asthma), medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product.
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 |
|---|---|---|
| Meplazumab for InjectionMeplazumab, an erythrocytic stage-macromolecular antibody drug, has the potential to control clinical occurrence of falciparum malaria. Meplazumab is a humanized anti-CD147 immunoglobulin G subclass 2 (IgG2) monoclonal antibody with strong affinity to CD147. CD147 is expressed on erythrocyte lineage cells throughout erythroid development, including mature erythrocytes and is the target for Plasmodium merozoites to allow reorientation and subsequent invasion of the erythrocytes. | Drug | Intervention Groups |
Primary outcome
The Number of participants with Drug-related SAE, All-cause SAE, Drug-related AESI, All-cause AESI.
Time frame: up to 26 weeks
To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection
The Number of Participants discontinuation/ withdrawals due to AE
Time frame: up to 26 weeks
To evaluate the safety of meplazumab in an adult population with uncomplicated, symptomatic P. falciparum infection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meplazumab for Injection in people with Malaria, run by Jiangsu Pacific Meinuoke Bio Pharmaceutical Co Ltd at 1 site in Kenya.
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 8 inclusion and 30 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 29 Oct 2024. 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 Kenya. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of participants with Drug-related SAE, All-cause SAE, Drug-related AESI, All-cause AESI. (time frame: up to 26 weeks). The study lists 2 primary outcomes in all. 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 29 Oct 2024.