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This is an open-label single arm study. All patients will receive the study drug. The aim of the study is to compare overall survival (OS) of patients with recurrent brain tumor, known as Glioblastoma (GBM) having high levels of a protein, Trophoblast cell surface antigen 2 (Trop-2), expression on treatment with Sacituzumab Govitecan (SG) versus lomustine only which has been used in the past.
Safe Stop IPI-NIVO Trial: Early discontinuation of nivolumab upon achieving a (confirmed) complete or partial response in patients with irresectable stage III or metastatic melanoma treated with first-line ipilimumab-nivolumab
Primary Aim: To assess the objective remission rate (ORR) of patients with recurrent craniopharyngiomas treated with amrlotinib . Secondary Aims: 1. To assess progression-free survival (PFS) and overall survival (OS) of patients with recurrent craniopharyngiomas treated with amrlotinib. 2. To analyze the disease control rate (DCR) of the Anrotinib treatment regimen in patients with recurrent craniopharyngiomas, including the proportion of patients in complete remission, partial remission and stable disease. 3. Monitor and evaluate the safety of amrutinib, especially the occurrence of drug-related adverse events (AEs) .
This is a first-in-human (FIH), multicenter, open-label Phase I study to evaluate the safety, tolerability, PK profile, immunogenicity, and preliminary efficacy of BA1302 in patients with advanced solid malignancies. The study includes a dose-escalation phase (Part A) and a dose-expansion phase (Part B).
Title: Safety and efficacy of CAR-T cell therapy for relapsed/refractory neuroblastoma and desmoplastic small round cell tumors: a single-arm, open-label trial. The CART used in this study will be provided by Shanghai YaKe Biotechnology Ltd. Aims: 1. To evaluate the safety and efficacy of GD2/B7H3 CAR-T therapy for relapsed/refractory neuroblastoma, and observe its pharmacokinetic/pharmacodynamic characteristics and the survival of CAR-T cells in relapsed/refractory neuroblastoma patients. 2. To evaluate the safety and efficacy of GD2/B7H3 CAR-T therapy for relapsed/refractory desmoplastic small round cell tumor, and observe its ...
This study is a single-center, open-label, single-arm, dose-exploration study to evaluate the safety and preliminary effectiveness of CD19-BCMA CAR-T in the treatment of refractory, generalized myasthenia gravis. The study is a dose escalation trial in adult, refractory, systemic MG patients. The Keyboard method will be used to perform dose escalation to explore the maximum tolerated dose (MTD). A total of 12 MG patients who meet the inclusion criteria are expected to be recruited.
Autoimmune encephalitis is an autoimmune disease of the central nervous system that targets neuronal autoantigens. Anti-neuronal autoantibodies are produced in patients, with anti-NMDAR antibody being the most common.Anti-NMDAR encephalitis can be severe and life-threatening. Anti-NMDAR autoantibodies against neurons are pathogenic and are mainly produced by autoreactive B cells and plasma cells. Therefore, early elimination of these abnormal immune cells is crucial for rapid improvement of the patient's condition. This study aims to explore the efficacy and safety of B cell depletion therapy (ofatumumab) followed by plasma cell depletion therapy (daratumumab) in the treatment of...
Enhanced recovery after surgery (ERAS) is a strategy of perioperative management aimed to accelerate the rehabilitation of patients through various optimized perioperative managements as well as ongoing adherence to a patient-focused, multidisciplinary, and multimodal approach. Alleviating the injury and stress caused by surgery or disease is the core principle of ERAS, which has been shown to reduce complication rates after surgery, promote patient recovery, decrease hospital length of stay and reduce costs. ERAS has been widely applied in many surgical perioperative fields, and it has achieved remarkable effects. However, there are few applications of ERAS in...
The goal of this clinical trial is to test the safety and preliminary efficacy of a new drug, KLS-1, in adults with different types of solid tumors and chronic lymphocytic leukemia (CLL). The main questions it aims to answer are: - To define Dose Limiting Toxicities (DLT) and maximum tolerated dose (MTD) of KLS-1 - To select the recommended Phase II Dose (P2D) of KLS-1 - To determine the single dose and multiple dose PK profile following IV administration of KLS-1 - What is the safest and most effective dose of KLS-1? - Does KLS-1 show anti-tumor activity in patients? - To evaluate preliminary efficacy of KLS-1 in up to 4 cohorts of locally...
The purpose of this study is to explore the safety profile and establish a recommended dose (RD) for phase II of the antibody-cytokine fusion protein L19TNF plus standard TMZ chemoradiotherapy in patients with newly diagnosed glioblastoma. The study will be conducted in three consecutive parts: a dose finding part to determine the RD of L19TNF in combination with chemoradiotherapy, followed by a signal seeking part that investigates first signs of activity and then an activity evaluation part that studies the efficacy of L19TNF in combination with chemoradiotherapy against chemoradiotherapy alone.
