Actively Recruiting
A Study of Universal CNK-UT Cell Injection to Treat Refractory Acute Graft-versus-Host Disease Evaluating Safety, Dosage, and Response in Patients After Stem Cell Transplantation
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-27
23
Participants Needed
2
Research Sites
80 weeks
Total Duration
On this page
Sponsors
F
First Affiliated Hospital of Zhejiang University
Lead Sponsor
S
ST Phi Therapeutics Co., Ltd
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating universal T-cells engineered with a chimeric natural killer receptor (CNK-UT) to treat patients aged 14 to 70 years who have steroid-refractory, steroid-resistant, or steroid-dependent acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation. This is a single-arm, open-label, multi-center pilot study designed to assess the safety, tolerability, effectiveness, pharmacokinetics, and pharmacodynamics of CNK-UT cells in this patient population. Participants will receive CNK-UT cell infusions in two stages: initially, a single ascending dose (SAD) will be given intravenously to determine the maximum tolerated dose, with dose-limiting toxicities monitored for 21 days. If no dose-limiting toxicities occur, participants may enter a multiple ascending dose (MAD) stage, where they will receive multiple doses with adjusted dosage and frequency based on the SAD outcomes. During the study, researchers will monitor treatment-related adverse events for up to one year and identify the maximum tolerated dose and incidence of dose-limiting toxicities within 21 days after the first infusion. Assessments will include safety evaluations, pharmacological monitoring, and efficacy measures. Participants will be followed closely throughout the treatment and observation periods to gather comprehensive data on the investigational therapy.
CONDITIONS
Official Title
Universal CNK-UT Therapy for Refractory aGVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 14 to 70 years, male or female
- Diagnosed with grade II to IV steroid-refractory, steroid-resistant, or steroid-dependent acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
- ECOG physical status score between 0 and 3
- Estimated life expectancy greater than 12 weeks
- Female participants of childbearing age must have a negative pregnancy test before enrollment and agree to use effective contraception during the trial
- Participants agree to voluntarily participate, understand the study, sign informed consent, and follow all procedures
You will not qualify if you...
- Diagnosed with malignant tumors within the past 5 years, excluding certain skin cancers and cancers treated with radical resection
- History of organ transplantation
- Previously undergone more than one allogeneic hematopoietic stem cell transplantation
- Uncontrolled hypertension, hypertensive crisis history, symptomatic congestive heart failure (NYHA III-IV), poorly controlled arrhythmias, congenital long QT syndrome, or QTc > 500 ms at screening
- Unstable severe pulmonary, hepatic, renal, or metabolic disorders requiring medication, excluding allo-HSCT complications
- Active pulmonary tuberculosis under treatment or treated within 1 year; HIV infection; known syphilis infection
- Severe active or poorly controlled infections
- Received treatment in other clinical trials within 12 weeks before this study
- Previously used any gene therapy products
- Allergy to CNK-UT injection components
- Known mental or substance abuse disorders affecting study compliance
- Pregnant or breastfeeding women, or planning pregnancy within 1 year after treatment
- Uncontrolled or uncorrectable metabolic or systemic diseases increasing medical risk or survival uncertainty
- Other conditions deemed unsuitable by the investigator
AI-Screening
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Trial Site Locations
Total: 2 locations
1
First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian, China
Actively Recruiting
2
The first affiliated hospital of zhejiang university, school of medicine.
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
L
Li Luo, MD
Y
Yibo Wu, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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