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 groupLocations
2First Affiliated Hospital of Fujian Medical University FuzhouFujian, China
The first affiliated hospital of zhejiang university, school of medicine.310000, HangzhouZhejiang, China
Sponsors and collaborators
First Affiliated Hospital of Zhejiang University
Lead sponsor
ST Phi Therapeutics Co., Ltd
Collaborator
Source ClinicalTrials.gov