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

Nuwacell Biotechnologies

Status and phase

Not yet enrolling

Phase 2

Phase 1

Conditions

Acute Graft-versus-Host Disease

Treatments

Biological: NCR102 injection

Study type

Interventional

Funder types

Industry

Identifiers

NCT06941350

NCR102-1001

Details and patient eligibility

About

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

Full 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.

Enrollment

24 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.