Recombinant Human Interleukin-7 (JL18008) for the Treatment of HIV-Infected Immunological Non-Responders

NCT07443228 | Not Yet Recruiting Phase 1 FDA Drug

• 1 other identifier: JL18008
• Study Type: interventional
• Target: 52
• Locations: 0 countries
• Sites: N/A

Brief Summary

JL18008 Injection is designed to improve the immune response in cART-treated HIV-infected immunological non-responders (HIV INRs). The study includes 3 trials： Phase Ia: A randomized, single-blind, placebo-controlled, single-dose escalation study to evaluate the tolerability and safety of JL18008 Injection and determine the RED in HIV INRs. Phase Ib: A randomized, double-blind, placebo-controlled, dose expansion study to evaluate the safety of JL18008 Injection and determine the RP2D in HIV INRs. Phase II: A randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of JL18008 Injection in HIV INRs.

Conditions

HIV

Outcome Measures

Primary Outcomes (3)

• The safety of JL18008

  Number of participants with any death.

  3 months

• The safety of JL18008

  Number of participants with AEs and SAEs.

  3 months

• The safety of JL18008

  Number of participants with discontinuation due to AEs.

  3 months

Secondary Outcomes (16)

• To Evaluate the Pharmacokinetics of JL18008

  Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.

• To Evaluate the Pharmacokinetics of JL18008

  Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day15), 504 (Day 22), 672 (Day 29) hours of post-dose.

• To Evaluate the Pharmacokinetics of JL18008

  Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.

• To Evaluate the Pharmacokinetics of JL18008

  Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.

• To Evaluate the Pharmacokinetics of JL18008

  Intensive PK sampling will be performed at the following time points: 0.5 hour of pre-dose and 0.5, 1, 2, 4, 8, 12, 24, 48, 72, 96, 120, 168 (Day 8), 240 (Day 11), 336 (Day 15), 504 (Day 22), 672 (Day 29) hours of post-dose.

Study Arms (8)

JL18008 i.m. 1 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 2 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 4 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 8 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 16 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 30 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 50 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

JL18008 i.m. 70 μg/kg

EXPERIMENTAL

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

Drug: JL18008

Interventions

JL18008 DRUG

The dose escalation scheme combines eight dose cohorts 1, 2, 4, 8, 16, 30, 50, and 70 μg/kg. Four subjects will be enrolled in the first 3 dose levels, and 8 subjects will be enrolled in the rest 5 dose levels. In this study, the eligible subjects will receive a single-dose JL18008 Injection or placebo.

JL18008 i.m. 1 μg/kg; JL18008 i.m. 16 μg/kg; JL18008 i.m. 2 μg/kg; JL18008 i.m. 30 μg/kg; JL18008 i.m. 4 μg/kg; JL18008 i.m. 50 μg/kg; JL18008 i.m. 70 μg/kg; JL18008 i.m. 8 μg/kg

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 18 - 65 years old, male or female.
• Body Mass Index (BMI) between 18 - 32 kg/m2, body weight ≥ 50 kg in male and ≥ 45 kg in female.
• On cART for at least 36 months, on stable regimen (no drug or dose changes) for at least 3 months prior to study entry.
• Plasma HIV RNA \< 50 copies/mL in last 30 months in minimum two measurements (including the screening measurement) and the two measurements should done within 6 months prior to study entry (note: patients with single blip of detectable viremia during this period will be allowed to participate if the prior and subsequent plasma HIV RNA levels are \< 50 copies/mL).
• During 12 months prior to study entry, CD4+ T cell counts \> 100 and ≤ 350 cells/µL measured in at least two measurements (including the screening measurement) and the interval between the two measurements should be ≥ 3 months (Note: only one time value of CD4+ T cell count \> 350 during this period will be allowed to participate if the previous and subsequent CD4+ T cell count is in the range of \> 100 and ≤ 350 cells/µL).
• All subjects must agree not to participate in the conception process (e.g. active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization), and if participating in sexual activity that could lead to pregnancy, the subject/partner must practice at least one form of barrier birth control (condoms, with or without spermicidal agent, a diaphragm or cervical cap with spermicide, an IUD, other barrier contraception, etc.), during study and 3 months after the study.
• The subject fully understands the requirements of the study and voluntarily signs the ICF.

You may not qualify if:

• Prior treatment with IL-7 or IL-2.
• Allergy to JL18008 Injection components, e.g. HSA.
• Prior treatment with immunomodulatory agents such as thymosin, immunosuppressive drugs, or cytotoxic chemotherapy within 6 months prior to study entry.
• Any history of generalized psoriasis, Crohn's disease, uveitis, systemic lupus erythematosus (SLE), Hashimoto's thyroiditis or other autoimmune diseases.
• Any history of virus, bacteria, parasites or fungal infection and other opportunistic infections requiring systemic treatment and/or hospitalization within 30 days prior to study entry.
• Active tuberculosis within 30 days prior to study entry.
• Any hematologic disease associated with hypersplenism, such as thalassemia, hereditary spherocytosis, Gaucher's Disease, and autoimmune hemolytic anemia.
• History of splenectomy.
• Any gastrointestinal illness associated with chronic or intermittent diarrhea.
• Severe cardiovascular disease: myocardial infarction, unstable angina pectoris, symptomatic congestive heart failure (New York Heart Association \> class II) or cardiac arrhythmia requiring medication within 6 months prior to study entry.
• Hypertension with a resting systolic blood pressure \> 140 mmHg or a resting diastolic blood pressure \> 90 mmHg despite adequate antihypertensive treatment.
• Hepatitis B Surface Antigen (HBs Ag) positive and/or Hepatitis C virus (HCV) antibody positive and HCV-RNA positive.
• Abnormal clinical laboratory tests results meet any of the following criteria: Hemoglobin (HGB) \< 120 g/L for men and \< 110 g/L for women; White blood cell (WBC) count \< 3.5 × 109/L; neutrophil count (NEUT) \< 1.5 × 109/L; Platelet (PLT) count \< 125 × 109/L; Creatinine (Cr) \> 1.1 × upper limit of normal value (ULN); Alanine aminotransferase (ALT) \> 1.1 × ULN; Aspartate aminotransferase (AST) \> 1.1 × ULN; Alkaline phosphatase (ALP) \> 1.1 × ULN; Total bilirubin (TBIL) \>1.1 × ULN; Phosphate level \< 2.5 mg/dL; International normalized ratio (INR) \> 1.3; Activated partial thromboplastin time (APTT) \< 1.5 × ULN.
• Any history of HIV related encephalopathy.
• Diagnosis of cancer within the last 5 years prior to study entry (except skin basal cell or squamous cell carrcinomas, and cutaneous Kaposi's sarcoma not requiring systemic therapy).

Sponsors & Collaborators

• Jecho Biopharmaceuticals Co., Ltd.: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2026
• First Posted: March 2, 2026
• Study Start: May 30, 2026
• Primary Completion (Estimated): December 20, 2029
• Study Completion (Estimated): December 31, 2030
• Last Updated: March 2, 2026

Record last verified: 2026-02