Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
- Conditions
- Graft vs Host Disease
- Registration Number
- NCT06568328
- Lead Sponsor
- Fujian Medical University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 17
Inclusion Criteria:<br><br> 1. Aged 1~70 years, male or female;<br><br> 2. Participants diagnosed with grade II~IV steroid-refractory/resistant or<br> steroid-dependent GVHD after allogeneic hematopoietic stem cell transplantation who<br> have failed treatment with ruxolitinib or at least one other second-line medication,<br> or who are intolerant to these medications.<br><br> 3. ECOG physical status score 0~3;<br><br> 4. Estimated life expectancy > 12 weeks;<br><br> 5. Female participants of childbearing age must undergo a serum or urine pregnancy test<br> before enrollment, and the results must be negative, and agree to take acceptable<br> measures to minimize the possibility of pregnancy during the trial; For female<br> participants of childbearing age or male participants whose sexual partners are<br> women of childbearing age, effective contraceptive measures should be taken during<br> the study and for at least 6 months following the last dose of the study cells<br> infusion.<br><br> 6. Participants voluntarily participate in clinical trial; Understand and know this<br> study, sign an informed consent form, and be willing to follow all experimental<br> procedures.<br><br>Exclusion Criteria:<br><br> 1. Suffering from malignant tumors or diagnosed within 5 years before enrollment,<br> excluding radical skin basal cell carcinoma, skin squamous cell carcinoma, thyroid<br> cancer, breast cancer (ductal carcinoma in situ) and / or radical resection of<br> carcinoma in situ.<br><br> 2. Participants with a history of organ transplantation;<br><br> 3. Participants who have previously undergone more than one allogeneic hematopoietic<br> stem cell transplantation.<br><br> 4. Uncontrolled hypertension as determined by principal investigator, a history of<br> hypertensive crisis or hypertensive encephalopathy; symptomatic congestive heart<br> failure (New York Heart Association classification III-IV); symptomatic or poorly<br> controlled arrhythmias; a history of congenital long QT syndrome or a corrected QT<br> interval (QTc) > 500 ms at screening (calculated using the Fridericia method)..<br><br> 5. Systemic diseases deemed unstable by principal investigator include, but are not<br> limited to, severe pulmonary, hepatic, renal, or metabolic disorders that require<br> pharmacological intervention (excluding complications related to allogeneic<br> hematopoietic stem cell transplantation).<br><br> 6. Active pulmonary tuberculosis (TB), who is receiving anti-tuberculosis treatment or<br> has received anti-tuberculosis treatment within 1 year before enrollment; human<br> immunodeficiency virus (HIV) infection, known syphilis infection.<br><br> 7. Severe infections that are active or poorly controlled clinically.<br><br> 8. Participants who have received treatment from other clinical trials within 12 weeks<br> prior to the initiation of the study.<br><br> 9. Participants who have previously used any gene therapy products prior to the<br> initiation of the study.<br><br> 10. Allergic to components of CNK-UT injection.<br><br> 11. Participants suffer from known mental or substance abuse disorders, which may<br> interfere with their ability to comply with research requirements.<br><br> 12. Women who are pregnant or breastfeeding, as well as male or female participants who<br> have planned for birth within 1 year after receiving medication.<br><br> 13. Uncontrolled/uncorrectable metabolic disorders or other non-malignant organ diseases<br> or systemic diseases or secondary reactions to cancer, which can lead to higher<br> medical risk and/or uncertainty in survival assessments.<br><br> 14. Other situations that the participant is identified by the investigator as<br> unsuitable to participate in the study.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of Treatment Related adverse events (AEs);Identification of Maximum Tolerated Dose (MTD) & incidence of Dose-limiting Toxicities (DLTs)
- Secondary Outcome Measures
Name Time Method Objective Response Rate (ORR);Best Overall Response (BOR);Duration of Response (DOR);Progression-free Survival (PFS);Overall survival (OS);Pharmacokinetics (PK) (Cmax);Pharmacokinetics (PK) (Tmax);Pharmacokinetics (PK);Levels of peripheral blood lymphocyte subsets