A Trial to Evaluate the Safety and Efficacy of NCR102 in Subjects With aGVHD

April 16, 2025 updated by: Nuwacell Biotechnologies Co., Ltd.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

24

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: NCR102 injection
Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection
Biological: NCR102 injection
Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
100 days after first administration of NCR102 injection

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ORR at Day 28
Time Frame: 28 days after first dose administration
Overall Response Rate(ORR) at Day 28
28 days after first dose administration
CRR at Day 28
Time Frame: 28 days after first dose administration
Complete Response Rate(CRR) at Day 28
28 days after first dose administration
ORR at Day 56
Time Frame: 56 days after first dose administration
Overall Response Rate(ORR) at Day 56
56 days after first dose administration

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuwacell Biotechnologies Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 28, 2025

Primary Completion (Estimated)

October 30, 2026

Study Completion (Estimated)

May 30, 2027

Study Registration Dates

First Submitted

April 16, 2025

First Submitted That Met QC Criteria

April 16, 2025

First Posted (Actual)

April 23, 2025

Study Record Updates

Last Update Posted (Actual)

April 23, 2025

Last Update Submitted That Met QC Criteria

April 16, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NCR102-1001

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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