/ Not yet recruitingPhase 1 一项评价NCR102注射液治疗急性移植物抗宿主病(aGVHD)的安全性、有效性的I/II期临床研究
[Translation] A Phase I/II clinical study to evaluate the safety and efficacy of NCR102 injection in the treatment of acute graft-versus-host disease (aGVHD)
主要目的:
Ⅰ期:评价NCR102注射液在II-IV度消化道受累的aGVHD患者中的安全性。
次要目的:
Ⅰ期:评价NCR102注射液在II-IV度消化道受累的aGVHD患者中的初步有效性、细胞动力学特征(CK)、免疫原性;探索与NCR102注射液临床疗效或作用机理相关的生物标志物。
[Translation] Primary objective:
Phase I: To evaluate the safety of NCR102 injection in patients with aGVHD with II-IV degree gastrointestinal involvement.
Secondary objective:
Phase I: To evaluate the preliminary efficacy, cell kinetic characteristics (CK), and immunogenicity of NCR102 injection in patients with aGVHD with II-IV degree gastrointestinal involvement; to explore biomarkers related to the clinical efficacy or mechanism of action of NCR102 injection.
/ Not yet recruitingPhase 1 评价NCR101注射液在间质性肺病患者中的安全性、耐受性和初步有效性的Ⅰ/Ⅱ期临床研究
[Translation] Phase I/II clinical study to evaluate the safety, tolerability and preliminary efficacy of NCR101 injection in patients with interstitial lung disease
主要目的:
Ⅰ期:评价NCR101注射液在间质性肺病患者中单次给药(SAD)和多次给药(MAD)的安全性和耐受性,确定临床用药的安全剂量。
次要目的:
Ⅰ期:评价NCR101注射液在间质性肺病患者中的初步有效性,为后续临床试验方案设计提供依据。
[Translation] Main purpose:
Phase I: To evaluate the safety and tolerability of single-dose (SAD) and multiple-dose (MAD) NCR101 injection in patients with interstitial lung disease, and to determine the safe dose for clinical use.
Secondary purpose:
Phase I: To evaluate the preliminary efficacy of NCR101 injection in patients with interstitial lung disease, and to provide a basis for the design of subsequent clinical trial programs.
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