The Phase Ib clinical trial is an add-on study based on combination antiretroviral therapy (cART). It adopts a multicenter, randomized, double-blind, placebo-controlled, multiple-dose design to evaluate the safety and efficacy of multiple intramuscular injections of JL18008 added to cART in HIV immunological non-responders (INRs).
Based on the Phase Ia clinical data, three dose groups are planned for the Phase Ib trial: 20, 40, and 70 μg/kg of JL18008. Each group is planned to enroll 10 subjects (8 receiving active drug and 2 receiving placebo). All subjects must maintain their original cART regimen unchanged. Subjects in the active treatment groups will receive JL18008 injection in addition to cART, while those in the control group will receive placebo (JL18008 injection buffer) in addition to cART. The dosing regimen is tentatively once weekly (QW) for 4 consecutive weeks, which constitutes one treatment cycle, followed by an observation/follow-up period. The study drug will be administered by intramuscular injection.
Age 18 to 65 years (inclusive), male or female.
Body mass index (BMI) 18.0 to 32.0 kg/m² (inclusive); body weight ≥50.0 kg for males and ≥45.0 kg for females.
Receiving combination antiretroviral therapy (cART) for at least 48 months, with a stable antiretroviral regimen for at least 3 months prior to enrollment.
Immunological non-responder criteria: CD4⁺ T cell count ≤350 cells/μL within 1 year before screening. At least three CD4⁺ T cell counts ≤350 cells/μL within 4 years before enrollment, with intervals of ≥3 months between tests (the third may be from screening).
Known allergy to the study drug or any of its excipients.
Receipt of immunosuppressants, immunomodulators, or systemic cytotoxic therapy within 3 months before screening.
Receipt of hormone therapy within 1 month before screening, except for daily doses ≤10 mg prednisone or equivalent.
History of severe autoimmune disease requiring systemic treatment or hospitalization, or any active autoimmune disease requiring treatment (including multiple sclerosis).
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Treatment groupsSee each treatment group below.