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

NCT06941350 | Not Yet Recruiting Phase 1

• 1 other identifier: NCR102-1001
• Study Type: interventional
• Target: 24
• Locations: 0 countries
• Sites: N/A

Brief Summary

Evaluate the safety and efficacy of NCR102 injection in the treatment of SR-aGVHD patients who have failed second-line therapy.

Conditions

Acute Graft-versus-Host Disease

Keywords

SR-aGVHD; NCR102; second-line treatment failure

Outcome Measures

Primary Outcomes (1)

• 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

  100 days after first administration of NCR102 injection

Secondary Outcomes (3)

• ORR at Day 28

  28 days after first dose administration

• CRR at Day 28

  28 days after first dose administration

• ORR at Day 56

  56 days after first dose administration

Study Arms (1)

NCR102 injection

EXPERIMENTAL

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

Biological: NCR102 injection

Interventions

NCR102 injection BIOLOGICAL

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

NCR102 injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead

Central Study Contacts

Yanqiu Li

CONTACT

400-888-2032; yqli@nuwacell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2025
• First Posted: April 23, 2025
• Study Start: April 28, 2025
• Primary Completion (Estimated): October 30, 2026
• Study Completion (Estimated): May 30, 2027
• Last Updated: April 23, 2025

Record last verified: 2025-04