About this trial
Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Single group
Treatments tested in this trial
NCR102 injection
Biological/VaccineTwice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.
Treatment groups
Trial outcomes
Primary outcomes
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Secondary outcomes
ORR at Day 28
Overall Response Rate(ORR) at Day 28
CRR at Day 28
Complete Response Rate(CRR) at Day 28
ORR at Day 56
Overall Response Rate(ORR) at Day 56
Locations
Sponsors and contacts
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