Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2025-12-24 @ 5:01 PM
NCT ID:
NCT06941350
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT06941350
Study Brief:
Protocol Section:
NCT06941350