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

NCT ID: NCT06941350

Last Updated: 2025-04-23

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-28
• Study Completion Date: 2027-05-30

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.

Conditions

Acute Graft-versus-Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

NCR102 injection

Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection

Group Type: EXPERIMENTAL

NCR102 injection

Intervention Type: BIOLOGICAL

Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.

Interventions

NCR102 injection

Twice a week for 4 weeks, and the treatment continues for another 4 weeks in subjects with partial remission by day 28.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nuwacell Biotechnologies Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Yanqiu Li

Role: CONTACT

yqli@nuwacell.com

400-888-2032

Other Identifiers

NCR102-1001

Identifier Type: -

Identifier Source: org_study_id