Actively Recruiting
Universal CNK-UT Therapy for Refractory aGVHD
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
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.
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
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
Y
Yibo Wu, MD
CONTACT
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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