Actively Recruiting
A Study of Universal CNK-UT Cell Injection in Patients With Refractory Acute Graft-versus-host Disease
Led by First Affiliated Hospital of Zhejiang University · Updated on 2024-12-27
23
Participants Needed
2
Research Sites
28 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 studying universal T-cells engineered with a chimeric natural killer receptor (CNK-UT) to treat patients with steroid-refractory, resistant, or steroid-dependent acute graft-versus-host disease (aGVHD) following allogeneic hematopoietic stem cell transplantation. This pilot, open-label, multi-center study aims to evaluate the safety, tolerability, effectiveness, and how the treatment behaves in the body. The trial is led by the First Affiliated Hospital of Zhejiang University and focuses on patients aged 14 to 70 years. The study involves two key phases: dose escalation and dose expansion. In the dose escalation phase, participants receive a single intravenous injection of CNK-UT cells at a dose of 3 x 10^7 CNK+ cells per kilogram of body weight to find the maximum tolerated dose and observe any dose-limiting toxicities within 21 days. If safe, participants may enter the dose expansion phase where multiple doses of CNK-UT cells (6 to 10 x 10^7 CNK+ cells/kg) are given. The dosage and frequency during this phase are adjusted based on findings from the dose escalation phase. Participants will be closely monitored for up to one year to assess treatment-related adverse events, response rates, progression-free survival, overall survival, and pharmacokinetics of the CNK-UT cells. Assessments include physical exams, laboratory tests, and blood analysis to track immune cell levels and drug behavior. The study also measures how long responses last and overall treatment effects through six months of follow-up. Participants will be required to attend scheduled visits for these evaluations during the study period.
CONDITIONS
Brief Title
Universal CNK-UT Therapy for Refractory aGVHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged 14-70 years, male or female
- Diagnosed with grade II to IV steroid-refractory, resistant, or steroid-dependent acute graft-versus-host disease after allogeneic hematopoietic stem cell transplantation
- Eastern Cooperative Oncology Group (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 study and for 6 months after the last dose
- Male participants with female partners of childbearing age must agree to use effective contraception during the study and for 6 months after the last dose
- Voluntary participation with informed consent and willingness to follow all study procedures
You will not qualify if you...
- Diagnosed with malignant tumors within 5 years before enrollment, except certain types like basal cell carcinoma, squamous cell carcinoma, thyroid cancer, breast ductal carcinoma in situ, or carcinoma in situ with radical resection
- History of organ transplantation
- More than one prior allogeneic hematopoietic stem cell transplantation
- Uncontrolled hypertension or history of hypertensive crises
- Symptomatic congestive heart failure (NYHA class III-IV) or poorly controlled arrhythmias
- History of congenital long QT syndrome or corrected QT interval over 500 ms
- Unstable systemic diseases requiring pharmacological treatment, excluding complications from stem cell transplantation
- Active or recent pulmonary tuberculosis, HIV infection, or known syphilis infection
- Active or poorly controlled severe infections
- Treatment in other clinical trials within 12 weeks prior to study start
- Prior use of any gene therapy products
- Allergy to components of CNK-UT injection
- Known mental or substance abuse disorders affecting compliance
- Pregnant or breastfeeding women, or plans for birth within 1 year after treatment
- Uncontrolled metabolic or organ disorders increasing medical risk
- Other conditions deemed unsuitable by the investigator
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 21 days for single dose escalation; multiple dosing duration varies based on study stage
Participants receive an intravenous infusion of CNK-UT cells. In the dose escalation stage, participants receive a single dose with a 21-day observation period for dose-limiting toxicities. In the dose expansion stage, participants may receive multiple doses according to dose escalation results.
1 infusion visit followed by frequent monitoring visits during the 21-day observation period; additional dosing and visits during dose expansion stage as determined
Duration - Up to 48 weeks
Participants are monitored for safety, response, and pharmacokinetics for up to 48 weeks after treatment.
Regular visits for assessments up to 48 weeks post-treatment
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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