Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
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 o
| Condition(s) | Graft vs Host Disease |
|---|---|
| Status | Recruiting |
| Phase | Phase 1 |
| Study type | Interventional |
| Summary | 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 GVHD. |
| Who can participate | Inclusion Criteria: 1. Aged 1\~70 years, male or female; 2. Participants diagnosed with grade II\~IV steroid-refractory/resistant or steroid-dependent GVHD after allogeneic hematopoietic stem cell transplantation who have failed treatment with ruxolitinib or at least one other second-line medication, or who are intolerant to these medications. 3. ECOG physical status score 0\~3; 4. Estimated life expectancy \> 12 weeks; 5. 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 during the trial; For female participants of childbearing age or male participants whose sexual partners are women of childbearing age, effective contracept |
| Ages | 1 Year to 70 Years |
| Sex | All |
| Lead sponsor | Fujian Medical University |
| Locations | Fuzhou, Fujian, China |
| Start date | 2024-09-01 |
| NCT ID | NCT06568328 |
| Official listing | https://clinicaltrials.gov/study/NCT06568328 |