Status:
NOT_YET_RECRUITING
A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD
Lead Sponsor:
Nuwacell Biotechnologies Co., Ltd.
Conditions:
Acute Graft-versus-Host Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.
Detailed Description
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-l...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2027
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT06941350
Start Date
April 28 2025
End Date
May 30 2027
Last Update
April 23 2025
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