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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

L9LS in Women of Childbearing Potential in Mali

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium Falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali

L9LS in Women of Childbearing Potential in Mali (NCT07060508) is a Phase 2 interventional studying Malaria, sponsored by National Institute of Allergy and Infectious Diseases (NIAID). RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Malaria and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 290 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Malaria subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 1. Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg. 2. Males aged ≥18 and ≤49 years (no weight restrictions). 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. In good general health and without clinically significant medical history. 5. Able to provide willing to sign a consent form. 6. Willing to have blood samples and data stored for future research. 7. Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study. 8. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study Day 0 through the final study visit as described below. 1. Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device. Who Should NOT Join This Trial: 1. Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female). 2. Currently breastfeeding. 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol. 4. Study comprehension examination score of \<80% correct or per investigator discretion. 5. Hemoglobin, WBC, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.) 6. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.) 7. Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV). 8. Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.) ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: 1. Females aged ≥18 and ≤49 years and weighing ≥ 45.0 and ≤ 90.0 kg. 2. Males aged ≥18 and ≤49 years (no weight restrictions). 3. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process. 4. In good general health and without clinically significant medical history. 5. Able to provide informed consent. 6. Willing to have blood samples and data stored for future research. 7. Resides in or near Kalifabougou, Faladje, or Torodo, Mali, and available for the duration of the study. 8. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to study Day 0 through the final study visit as described below. 1. Reliable methods of birth control include 1 of the following: confirmed pharmacologic contraceptives via parenteral delivery or intrauterine or implantable device. Exclusion Criteria: 1. Pregnancy, as determined by a positive urine or serum beta-human choriogonadotropin (β hCG) test (if female). 2. Currently breastfeeding. 3. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol. 4. Study comprehension examination score of \<80% correct or per investigator discretion. 5. Hemoglobin, WBC, absolute neutrophil, or platelet count outside the local laboratory-defined limits of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.) 6. Alanine transaminase (ALT) or creatinine (Cr) level above the local laboratory-defined upper limit of normal. (Participants may be included at the investigator's discretion for "not clinically significant" values.) 7. Infected with HIV, hepatitis C virus (HCV), or hepatitis B virus (HBV). 8. Known or documented sickle cell disease by history. (Note: Known sickle cell trait is NOT exclusionary.) 9. Clinically significant abnormal electrocardiogram (ECG; QTc \>460 or other significant abnormal findings, including unexplained tachycardia or bradycardia). 10. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis. 11. Receipt of any investigational product within the past 30 days. 12. Participation or planned participation in an interventional trial with an investigational product until the last required protocol visit. \[Note: Past, current, or planned participation in observational studies is NOT exclusionary; participation in the placebo arm of the Mali adult CIS43LS MAb trial (ClinicalTrials.gov Identifier: NCT04329104) or the placebo arm of the Mali adult L9LS Mab trial (ClinicalTrials.gov Identifier: NCT05816330) is NOT exclusionary.\] 13. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months. 14. History of a severe allergic reaction or anaphylaxis. 15. Severe asthma (defined as asthma that is unstable or required emergent care, urgent care, hospitalization, or intubation during the past 2 years, or that has required the use of oral or parenteral corticosteroids at any time during the past 2 years). 16. Pre-existing autoimmune or antibody-mediated diseases including but not limited to: systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjögren's syndrome, or autoimmune thrombocytopenia. 17. Salivary gland disorder diagnosed by a doctor (e.g., parotitis, sialadenitis, sialolithiasis, salivary gland tumors). 18. Known immunodeficiency syndrome. 19. Known asplenia or functional asplenia. 20. Use of chronic (≥14 days) oral or IV corticosteroids (excluding topical or nasal) at immunosuppressive doses (i.e., prednisone \>10 mg/day) or immunosuppressive drugs within 30 days of day 0. 21. Receipt of a live vaccine within the past 4 weeks or a killed vaccine within the past 2 weeks prior to study agent administration. 22. Receipt of immunoglobulins and/or blood products within the past 6 months. 23. Previous receipt of an investigational malaria vaccine or MAb in the last 5 years. 24. Known allergies or contraindication against artemether lumefantrine. 25. Other condition(s) that, in the opinion of the investigator, would jeopardize the safety or rights of a participant participating in the trial, interfere with the evaluation of the study objectives, or render the participant unable to comply with the protocol.

Treatments Being Tested

BIOLOGICAL

Single dose of 1800 mg L9LS SC

A human monoclonal antibody to protect against Plasmodium falciparum.

OTHER

Placebo

Normal saline

Locations (3)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Faladje MRTC Clinic
Faladié, Koulikoro, Mali
Kalifabougou MRTC Clinic
Kalifabougou, Koulikoro, Mali
Torodo MRTC Clinic
Torodo, Koulikoro, Mali

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07060508), the sponsor (National Institute of Allergy and Infectious Diseases (NIAID)), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07060508 clinical trial studying?

Safety and Efficacy of L9LS, a Human Monoclonal Antibody Against Plasmodium falciparum, in a Randomized, Double-Blind, Placebo-Controlled Trial of Women of Childbearing Potential (WOCBP) in Mali The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07060508?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07060508?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07060508. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07060508. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.