eligibility_summary
Eligibility: adults 18–50 with consent, clinic access, good health and normal labs, HIV/HBV/HCV negative, low HIV risk, HIV counseling. Pregnancy-capable: negative test and effective contraception/abstinence. Exclude: weight <35 or >115 kg, pregnancy/breastfeeding, other trials/recent vaccines, mAbs/IG/immunosuppressants, major medical/psychiatric, uncontrolled HTN/asthma, diabetes (except diet-controlled T2), TB therapy, seizures <3y, malignancy, asplenia, bleeding disorder, severe allergy.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
manual_review_required
ai_summary
Trial: Phase 1, IV infusions of three broadly neutralizing monoclonal antibodies (bNAbs) in HIV‑negative adults, status suspended after a mild AE with VRC01.23LS. Interventions and mechanisms (all are long‑acting LS‑engineered human IgG1 bNAbs with extended half‑life via FcRn binding): • VRC01.23LS: targets the HIV‑1 envelope (Env) CD4‑binding site on gp120, blocking attachment to CD4 and preventing viral entry, may mediate Fc‑effector functions (ADCC/ADCP) against Env‑expressing cells. • PGT121.414.LS: targets the gp120 V3‑glycan supersite, neutralizing diverse strains and potentially engaging Fc‑effector mechanisms. • PGDM1400LS: targets the gp120 V2‑apex epitope on the native trimer, neutralizing entry and enabling Fc‑effector activity. Targeted cells/pathways: HIV‑1 Env on virions and infected CD4+ T cells, blockade of the gp120–CD4/CCR5(CXCR4) entry pathway, secondary engagement of FcγR‑bearing effector cells (e.g., NK cells, macrophages). Combination and dose‑escalation cohorts assess safety/PK.