Clinical Trial

Immunogenicity and safety of co-administration with the Sabin-strain-based inactivated poliovirus vaccine (vero cell) and the diphtheria-tetanus-acellular pertussis vaccine in eligible children in China: a randomized, controlled, multicenter, non-inferiority trial

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ObjectiveIn developing countries, combined vaccine availability remains limited due to economic constraints, healthcare infrastructure, and supply chain challenges. While some imported combined vaccines are available in China, their accessibility is re…

The endoplasmic reticulum stress status of CD4+ T lymphocytes and its association with mTOR-mediated autophagic-lysosomal disorder in elderly sepsis patients

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Aimsto clarify the endoplasmic reticulum stress (ERS) status of CD4+ T lymphocytes in sepsis patients, particularly elderly individuals aged over 65 years, and to elucidate its association with mTOR-mediated autophagic-lysosomal disorder.Methods62 seps…

The impact of enteral immunonutrition on gut microbiota in colorectal cancer and gastric cancer patients in the preoperative period—preliminary results of randomized clinical trial

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IntroductionImmunonutrition is a part of nutritional interventions in gastrointestinal cancer patients. It seems to be especially important in the preoperative period to reduce, among others, surgery-related complications. The relation between the immu…

Impact of first-line chemoimmunotherapy with or without radiotherapy on the prognosis of patients with locally advanced or metastatic esophageal squamous cell carcinoma: a multicenter, real-world, retrospective cohort study from China (NCT06478355)

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BackgroundChemotherapy combined with immunotherapy has already become the standard first-line treatment for advanced or metastatic esophageal squamous cell carcinoma (ESCC), whereas there are no satisfying overall survival (OS) and progression-free sur…

Anti-CD19 CAR-T cell therapy in relapsed/refractory t(8;21) acute myeloid leukemia with aberrant CD19 expression

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BackgroundT (8; 21) acute myeloid leukemia (AML) is a special type of acute leukemia, and exhibits a heterogeneous prognosis, with a long-term relapse rate of about 40%. Once t(8; 21) AML patients experience relapse, they have an extremely poor prognos…

Immunogenicity and safety study of 23-valent pneumococcal polysaccharide vaccine revaccination among elderly individuals aged 60–70 years in Shanghai, China

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BackgroundTo understand the immunogenicity and safety of the 23-valent pneumococcal polysaccharide vaccine in elderly individuals aged 60–70 years in Shanghai after revaccination.MethodsA total of 330 elderly people aged 60–70 years were recruited to s…

A noteworthy issue: microbiome data variation depending on sampling methods in skin microecology studies in acne vulgaris patients

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IntroductionSkin microecology significantly affects health, with the microbiome being a complex community of microorganisms. Different niche preferences of microorganisms raise concerns about the adequacy of common sampling methods like swabbing and cy…

Phase I/II clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes for the prevention of leukemia relapse in children given haploidentical hematopoietic stem cell transplantation: study rational and design

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Leuk-CTL-001 (EudraCT n. 2019-003362-41) is a Phase I/II clinical trial on the safety and preliminary efficacy of donor-derived anti-leukemia cytotoxic T lymphocytes (CTLs) for the prevention of leukemia relapse in children given haploidentical hematop…

First-in-human evaluation of a no-alpha interleukin–2 mutein: safety and preliminary pharmacodynamic and clinical effect

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IntroductionInterleukin 2 (IL-2) is essential for immune system activation. To reduce toxicity and prevent the activation of regulatory T cells (T-regs), a novel IL-2 variant containing 4-point mutations that prevent its interaction with the alpha chai…

A phase 2a double-blind, placebo-controlled, randomized clinical trial evaluating the efficacy and safety of NuGel, a novel topical GPCR19-mediated inflammasome inhibitor, in patients with mild to moderate atopic dermatitis: a proof-of-concept study with Post-hoc biomarker analysis

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BackgroundCurrent guidelines to treat atopic dermatitis (AD) overlook disease heterogeneity, limiting personalized care. This study assessed NuGel, a topical GPCR19 agonist, for efficacy, safety, and predictive baseline biomarkers in AD patients.Method…

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