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New treatment option for Acute Graft-versus-Host Disease
Official title Universal CNK-UT Therapy for Refractory aGVHD
ClinicalTrials.gov ID: NCT06750133
What this study is testing
What is Chimeric Natural Killer Receptor Universal T-cells (CNK-UT)?
Chimeric Natural Killer Receptor Universal T-cells (CNK-UT) is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for acute graft-versus-host disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 14 to 70
You may be able to join if
- 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...
- ECOG physical status score 0\~3;
- Estimated life expectancy \> 12 weeks;
- Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree...
You likely can't join if
- Suffering from malignant tumors or diagnosed within 5 years before enrollment, excluding radical skin basal cell carcinoma, skin squamous cell...
- 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...
- Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders...
- Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before...
See the full eligibility criteria
- 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;
- Female participants of childbearing age must undergo a serum or urine pregnancy test before enrollment, and the results must be negative, and agree to take acceptable measures to minimize the possibility of pregnancy...
- Participants voluntarily participate in clinical trial; Understand and know this study, sign an informed consent form, and be willing to follow all experimental procedures.
- 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...
- 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...
- Systemic diseases deemed unstable by principal investigator include, but are not limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require pharmacological intervention (excluding complications...
- Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or has received anti-tuberculosis treatment within 1 year before enrollment; human immunodeficiency virus (HIV) infection, known syphilis...
- Severe infections that are active or poorly controlled clinically.
- Participants who have received treatment from other clinical trials within 12 weeks prior to the initiation of the study.
- Participants who have previously used any gene therapy products prior to the initiation of the study.
- Allergic to components of CNK-UT injection.
- Participants suffer from known mental or substance abuse disorders, which may interfere with their ability to comply with research requirements.
- Women who are pregnant or breastfeeding, as well as male or female participants who have planned for birth within 1 year after receiving medication.
- Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases or systemic diseases or secondary reactions to cancer, which can lead to higher medical risk and/or uncertainty in survival...
- Other situations that the participant is identified by the investigator as unsuitable to participate in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Fuzhou, Fujian, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 14 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Fuzhou, Fujian, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.