Acute Graft-versus-Host Disease
Conditions
Keywords
SR-aGVHD, NCR102, second-line treatment failure
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-line therapy.
Interventions
BIOLOGICALNCR102 injection
Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.
Sponsors
Nuwacell Biotechnologies Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Event(AE) or Serious Adverse Event(SAE) | 100 days after first administration of NCR102 injection | Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR at Day 28 | 28 days after first dose administration | Overall Response Rate(ORR) at Day 28 |
| CRR at Day 28 | 28 days after first dose administration | Complete Response Rate(CRR) at Day 28 |
| ORR at Day 56 | 56 days after first dose administration | Overall Response Rate(ORR) at Day 56 |
Contacts
Primary ContactYanqiu Li
Outcome results
None listed