Acute Graft-versus-Host DiseasePhase 1/2NCT06941350
A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD
A Phase 1/2 study testing NCR102 injection in people with Acute Graft-versus-Host Disease, run by Nuwacell Biotechnologies Co., Ltd..
Trial summary
Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Graft-versus-Host Disease
- What is being tested?
- NCR102 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 28 Apr 2025to 30 May 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase I/II Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)
Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.
Read the 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.
- Conditions
- Acute Graft-versus-Host Disease
- Being tested
- NCR102 injection
- Keywords
- SR-aGVHD, NCR102, second-line treatment failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCR102 injectionBiological
Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.
| Study group | Role | What they receive |
|---|---|---|
| NCR102 injection | Experimental | Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection Receives: Biological: NCR102 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 100 days after first administration of NCR102 injection
Secondary outcomes (3)
ORR at Day 28
Overall Response Rate(ORR) at Day 28
Measured: 28 days after first dose administration
CRR at Day 28
Complete Response Rate(CRR) at Day 28
Measured: 28 days after first dose administration
ORR at Day 56
Overall Response Rate(ORR) at Day 56
Measured: 56 days after first dose administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2025
- Study start28 Apr 2025 (estimated)
- Primary completion30 Oct 2026 (estimated)
- Study completion30 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06941350
- Sponsor's protocol ID
- NCR102-1001
- Status last verified
- Apr 2025
- First submitted
- 16 Apr 2025
- Last updated
- 23 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/II Clinical Study Evaluating the Safety and Efficacy of NCR102 Injection in the Treatment of Acute Graft-versus-Host Disease (aGVHD)
- ClinicalTrials.gov ID
- NCT06941350
- Acronym / sponsor ID
- NCR102-1001
- Conditions
- Acute Graft-versus-Host Disease
- Keywords
- SR-aGVHD, NCR102, second-line treatment failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 28 Apr 2025 (estimated)
- Primary completion
- 30 Oct 2026 (estimated)
- Study completion
- 30 May 2027 (estimated)
- First posted
- 23 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCR102 injection | Experimental | Biological: NCR102 injectionCohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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；
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCR102 injectionTwice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28. | Biological | NCR102 injection |
Primary outcome
Adverse Event(AE) or Serious Adverse Event(SAE)
Time frame: 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
3 secondary outcomes
ORR at Day 28
Time frame: 28 days after first dose administration
CRR at Day 28
Time frame: 28 days after first dose administration
ORR at Day 56
Time frame: 56 days after first dose administration
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing NCR102 injection in people with Acute Graft-versus-Host Disease, run by Nuwacell Biotechnologies Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yanqiu Li (400-888-2032, yqli@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse Event(AE) or Serious Adverse Event(SAE) (time frame: 100 days after first administration of NCR102 injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2025.