2024-513938-38-00招募中2 期
An open-label dose-escalation study evaluating the safety, pharmacokinetics and antiviral activity of IMC-M113V in HLA-A*2:01 positive subjects with chronic HIV infection who are virologically suppressed.
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 6
- 主要终点
- • Incidence and severity of treatment-emergent adverse events (TEAEs) • Incidence of dose-limiting toxicities (DLTs) • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF) • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment
研究概览
简要总结
Part 1: Single Ascending Dose (SAD) Study To evaluate the safety and tolerability of IMC-M113V when administered as a single dose during antiretroviral therapy (ART) Part 2: Multiple Ascending Dose (MAD) Study • To evaluate the safety and tolerability of IMC-M113V when administered in a multiple dose schedule, up to at least week 12, in participants receiving ART
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 主要目的
- Follow-Up Periods
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •18-65 years
- •HLA-A*02:01-positive
- •Evidence of HIV-1 infection • On continuous ART for a minimum of 12 months and maximum of 15 years • Consistently undetectable plasma HIV RNA (< 50 copies/mL) throughout the 12-month period prior to screening • Current CD4+ T cell count > 450 cells/μL and CD4+ cells >15% total lymphocytes • CD4+ T cell nadir > 200 cells/μL
- •Contraception
- •Informed Consent
排除标准
- •Confirmed HIV controller with HIV RNA consistently below 2000 copies/mL for at least 12 months and on ≥ 2 determinations.
- •Participation in other interventional studies
- •If any of the following laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered not clinically significant by the physician Investigator, the participant may be considered for enrolment: a. Hemoglobin < 120 g/L for participants assigned male at birth; < 110 g/L for participants assigned female at birth b. Platelet count < 150 × 109/L c. Alanine aminotransferase (ALT) > 3 × ULN (upper limit of normal) d. eGFR(Foundation, 2009) < 60 mL/min/1.73 m2 (calculated using CKD-EPI equation, 2009; or measured)
- •Inability or unwillingness to adhere to safer sex practices during ART interruption.
- •Hypersensitivity to study treatment or excipient Any medical condition that would interfere with the participation in the study
- •Initiated ART within 12 weeks of a diagnosis of primary HIV infection (PHI) Diagnosis of PHI is confirmed by any of: a. positive HIV-1 serology preceded by a recent negative HIV-1 antibody (Ab) test, b. Negative HIV Ab test plus positive viral antigen or RNA test c. HIV-1 Ab avidity test consistent with recent infection, or d. Weakly reactive or equivocal 4th generation HIV Ab/Ag test.
- •Recent diagnosis of an AIDS-defining condition within 90 days prior to screening excludes participation in Part
- •Any history of AIDS-defining condition excludes participation in Part
- •Individuals receiving an ART regimen containing a non-nucleoside reverse transcriptase inhibitor may not enrol in Part 2 unless willing and able to switch to a short-acting alternative prior to receiving their first dose of study drug.
- •Medical Conditions Co-infection with HBV Current active Mycobacterium tuberculosis infection or known untreated latent infection. Significant cardiovascular disease or impaired cardiac function Active autoimmune disease requiring immunosuppressive treatment Prior solid organ or bone marrow transplant. History of malignant disease Pregnant or lactating women.
- •Recent immunotherapy medication Systemic treatment with steroids or any other immunosuppressive drug use
- •Prior treatment with investigational HIV-targeted therapy
- •Recent use of live vaccine
- •Prior treatment with ImmTAC molecule
结局指标
主要结局
• Incidence and severity of treatment-emergent adverse events (TEAEs) • Incidence of dose-limiting toxicities (DLTs) • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF) • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment
• Incidence and severity of treatment-emergent adverse events (TEAEs) • Incidence of dose-limiting toxicities (DLTs) • Changes in safety laboratory parameters, vital signs, and electrocardiogram (QTcF) • Incidence of serious adverse events (SAEs) and AEs leading to treatment interruption, dose reduction, or discontinuation through 28 days after the last infusion of study treatment
次要结局
- IMC-M113V pharmacokinetics (PK) parameters (eg, AUC, Cmax, Tmax, t1/2) at multiple time points from baseline up to 72 hours post-dose in SAD and MAD (first dose) and after each subsequent dose in MAD studies Incidence of anti-IMC-M113V antibody formation following administration of one or more doses of study drug
- Change in serum cytokines/chemokines and peripheral blood lymphocyte counts (absolute values and fold-change) from baseline through 72 hours post-dosing with IMC-M113V in SAD and MAD schedules and during Follow-Up.
- • Proportion of participants with pVL < 200 copies/mL 12 weeks after interruption of ART (W24) • Proportion of participants resuming ART before W24 • Duration of post-treatment control (pVL < 200 copies/mL) after interruption of ART • Duration of virological suppression (pVL <1000 copies/mL) after interruption of ART Identification of at least 1 tolerable dosing regimen for further evaluation in subsequent development
研究者
Regulatory Affairs
Scientific
Immunocore Limited
研究点 (6)
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