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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.
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
Time frame: 100 days after first administration of NCR102 injection
ORR at Day 28
Overall Response Rate(ORR) at Day 28
Time frame: 28 days after first dose administration
CRR at Day 28
Complete Response Rate(CRR) at Day 28
Time frame: 28 days after first dose administration
ORR at Day 56
Overall Response Rate(ORR) at Day 56
Time frame: 56 days after first dose administration
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.