Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
ConditionGraft vs Host Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age1-70
SponsorFujian Medical 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 GVHD.
Eligibility criteria
Qualifiers
Aged 1~70 years, male or female;
Participants diagnosed with grade II~IV steroid-refractory/resistant or steroid-dependent GVHD after allogeneic hematopoietic stem cell transplantation who have failed treatment with ruxolitinib or at least one other second-line medication, or who are intolerant to these medications.
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
17 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov