A Trial to Evaluate the Safety and Efficacy of NCR102 in... | NCT06941350

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

NCT06941350

Sponsor

Nuwacell Biotechnologies Co., Ltd.

Status

Not yet recruiting

Last Update Posted

Apr 23, 2025Actual

Enrollment

24Estimated

Phase

Phase 1Phase 2

Conditions

Acute Graft-versus-Host Disease

Interventions

NCR102 injection

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2025

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 28, 2025Estimated

Primary Completion Date

Oct 30, 2026Estimated

Completion Date

May 30, 2027Estimated

First Submitted Date

Apr 16, 2025

First Submission Date that Met QC Criteria

Apr 16, 2025

First Posted Date

Apr 23, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 16, 2025

Last Update Posted Date

Apr 23, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

24Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
NCR102 injection	Experimental	Cohort1：Low dose NCR102 injection; Cohort2：High dose NCR102 injection	Biological: NCR102 injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided