CTIS2024-513938-38-00进行中（未招募）1 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. - IMC-M113V-103
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •18-65 years, HLA-A*02:01-positive, = 50 kg, •Evidence of HIV-1 infection •On continuous ART for a minimum of 12 months and maximum of 7 years •Consistently undetectable plasma HIV RNA (< 50 copies/mL) throughout the 12-month period prior to screening •Current CD4+ T cell count > 500 cells/µL •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 1. Any history of AIDS-defining condition excludes participation in Part 2., 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
研究者
相似试验
进行中（未招募）
1 期
Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infectioEUCTR2021-002008-11-ESImmunocore Limited53
招募中
2 期
Phase 1/2 study of IMC-M113V in virologically suppressed chronic HIV infection2024-513938-38-00Immunocore Limited20
进行中（未招募）
1 期
An Open-Label Safety, Tolerability and Dose-Range Finding Study of Multiple Doses of Nusinersen (ISIS 396443) in Participants With Spinal Muscular AtrophySpinal Muscular Atrophy (SMA)EUCTR2017-000327-27-Outside-EU/EEAIonis Pharmaceuticals, Inc.34
进行中（未招募）
1 期
A phase IIa open-label dose-escalation study using ICX-RHY to enhance the aesthetic appearance of nasolabial folds - RHY IIaModerately severe wrinklesMedDRA version: 8.1Level: LLTClassification code 10048042Term: WrinklesEUCTR2006-003639-59-GBIntercytex16
招募中
2 期
Study of Subretinally Injected AAVB-081 in Patients with Usher Syndrome Type IB (USH1B) Retinitis Pigmentosa2024-518489-29-00Aavantgarde Bio S.r.l.9