A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD
Phase 1
Not yet recruiting
- Conditions
- Acute Graft-versus-Host Disease
- Interventions
- Biological: NCR102 injection
- Registration Number
- NCT06941350
- Lead Sponsor
- Nuwacell Biotechnologies Co., Ltd.
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 24
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description NCR102 injection NCR102 injection Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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