Universal CNK-UT Therapy for Refractory aGVHD

ConditionAcute Graft-versus-Host Disease

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age14-70

SponsorFirst Affiliated Hospital of Zhejiang University

About this trial

This is a single arm, open-label, multi-center, pilot studies (Investigator Initiated Trial, IIT) to evaluate the safety, tolerability, efficacy, pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor (CNK-UT) to treat the patients with steroid-refractory/resistant or steroid-dependent aGVHD.

Eligibility criteria

Qualifiers

Aged 14-70 years, male or female;

Participants diagnosed with grade II~IV steroid-refractory/resistant or steroid-dependent aGVHD after allogeneic hematopoietic stem cell transplantation.

ECOG physical status score 0~3;

Estimated life expectancy > 12 weeks;

Disqualifiers

Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid cancer, breast cancer (ductal carcinoma in situ) and / or radical resection of carcinoma in situ.

Participants with a history of organ transplantation;

Participants who have previously undergone more than one allogeneic hematopoietic stem cell transplantation.

Uncontrolled hypertension as determined by principal investigator, a history of hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart failure (New York Heart Association classification III-IV); symptomatic or poorly controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT interval (QTc) > 500 ms at screening (calculated using the Fridericia method)..

Trial design

Treatments tested in this trial

Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)

Treatment groups

23 Participants

are divided into 1 treatment group

Sponsors and collaborators

First Affiliated Hospital of Zhejiang University

Lead sponsor

ST Phi Therapeutics Co., Ltd

Collaborator

Source ClinicalTrials.gov