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A Study to Evaluate JL18008 in Subject With HIV Immunological Non-Responders

ConditionHIV Infections
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-65
SponsorJecho Biopharmaceuticals Co., Ltd.

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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).

Trial design

Design model

Parallel

Treatments tested in this trial

  • JL18008 20 μg/kg

    Drug

    Participants receive JL18008 20 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

  • Placebo (for 20 μg/kg Group)

    Drug

    Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

  • JL18008 40 μg/kg

    Drug

    Participants receive JL18008 40 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

  • Placebo (for 40 μg/kg Group)

    Drug

    Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

  • JL18008 70 μg/kg

    Drug

    Participants receive JL18008 70 μg/kg by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

  • Placebo (for 70 μg/kg Group)

    Drug

    Participants receive placebo (JL18008 injection buffer) by intramuscular injection once weekly for 4 weeks, in addition to their stable combination antiretroviral therapy (cART).

Treatment groups

30 Participants
are divided into 6 treatment groups

6

Treatment groups

See each treatment group below.

Group A: JL18008 20 μg/kgExperimental treatment 1 intervention
Group B: Placebo (for 20 μg/kg Group)Placebo comparator 1 intervention
Group C: JL18008 40 μg/kgExperimental treatment 1 intervention
Group D: Placebo (for 40 μg/kg Group)Placebo comparator 1 intervention
Group E: JL18008 70 μg/kgExperimental treatment 1 intervention
Group F: Placebo (for 70 μg/kg Group)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Number of Participants with Treatment-Emergent Adverse Events (TEAEs) as Assessed by DAIDS v2.1

The incidence and severity of adverse events (AEs) and serious adverse events (SAEs). Adverse events are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1. Assessed from first dose up to Week 24.

Time frame
Up to 24 weeks
2

Change from Baseline in Vital Signs: Pulse Rate (bpm)

Change from baseline in pulse rate. Measured in beats per minute (bpm). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.

Time frame
Up to 24 weeks
3

Change from Baseline in Vital Signs: Systolic and Diastolic Blood Pressure (mmHg)

Change from baseline in systolic blood pressure (SBP) and diastolic blood pressure (DBP). Both measured in millimeters of mercury (mmHg). Assessed at baseline and Weeks 1, 4, 8, 12, 16, 20, and 24.

Time frame
Up to 24 weeks
4

Change from Baseline in Hematology Parameters

Change from baseline in hematology parameters including white blood cell count (10\^9/L), hemoglobin (g/L), platelet count (10\^9/L), neutrophil count (10\^9/L), lymphocyte count (10\^9/L), and red blood cell count (10\^12/L). Assessed at baseline and Weeks 1, 2, 4, 8, 12, 16, 20, and 24.

Time frame
Up to 24 weeks

Secondary outcomes

1

Proportion of Participants with CD4⁺ T Cell Count Increase ≥100 cells/μL from Baseline

Proportion of participants achieving an increase from baseline in CD4⁺ T cell count of at least 100 cells/μL. Assessed at baseline and Weeks 4, 8, 12, 16, 20, and 24.

Time frame
Up to 24 weeks
2

Proportion of Participants Achieving CD4⁺ T Cell Count ≥500 cells/μL

Proportion of participants with CD4⁺ T cell count reaching 500 cells/μL or higher. Assessed at Weeks 4, 8, 12, 16, 20, and 24.

Time frame
Up to 24 weeks
3

Proportion of Participants with Average CD4⁺ T Cell Count Increase ≥100 cells/μL over 12 Weeks

Proportion of participants with average increase from baseline in CD4⁺ T cell count of at least 100 cells/μL over the first 12 weeks. Assessed from baseline through Week 12.

Time frame
Baseline through Week 12
4

Proportion of Participants with Average CD4⁺ T Cell Count ≥500 cells/μL over 12 Weeks

Proportion of participants with average CD4⁺ T cell count of 500 cells/μL or higher over the first 12 weeks. Assessed from baseline through Week 12.

Time frame
Baseline through Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Jecho Biopharmaceuticals Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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