A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD

A Phase I/II Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)

Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

An open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

Inclusion Criteria:

• Age>18 years and <70 years old (including threshold), gender not limited；
• Grade II to IV gastrointestinal involvement acute graft-versus-host disease(aGVHD)；
• Subjects with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)；
• Failed to second-line aGVHD treatment;
• Subjects will receive NCR102 injection treatment within 3 days after enrollment;
• Voluntarily sign an informed consent form.

Exclusion Criteria:

• Subjects have lung disease, and investigators have determined that they are not suitable for the study;
• Subjects with severe hepatic vein occlusion disease or sinus vein occlusion syndrome;
• Subjects with signs/symptoms of chronic GVHD;
• Subjects who are clinically assessed by the investigator could not be ruled out as having diarrhea caused by cytomegalovirus (CMV) enteritis, transplant related thrombotic microvascular disease (TA-TMA), or digestive tract infection;
• Eastern Cooperative Oncology Group(ECOG)>3；
• Subjects have other diseases or physiological conditions that may interfere with the evaluation results of this trial, or life-threatening complications；
• Subjects had active malignant solid tumors within the past 5 years；
• Subjects had a known history of severe allergies to blood products, or heterologous proteins.