Pan-T Booster Co-expressing MSLN CAR T Cell Therapy in Advanced/Metastatic Solid Tumors
In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive a
| Condition(s) | Advanced or Metastatic Solid Tumors |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | In preclinical study, investigators have demonstrated that the newly developed pan-T booster (harbouring CD40 agonist and one T cell costimulator agonist) co-expressing MSLN CAR T cell possess more powerful antitumor activity than previously reported MSLN-CAR T cells. In this clinical trial, enrolled patients receive an initial dose of pan-T booster co-expressing MSLN CAR T cells at 1×10\^6 cells/kg based on the basic principle of dose escalation design, in order to evaluate the safety, feasibility, pharmacokinetics/pharmacodynamics, and efficacy of pan-T booster co-expressing MSLN CAR T cell in vivo. |
| Who can participate | Inclusion Criteria: * 1\. Age from 18 to 75 years with estimated life expectancy \>3 months. * 2\. Histopathological confirmed advanced or metastatic solid tumors failed to at least first-line treatment or initially diagnosed advanced/metastatic solid tumors that have no NCCN guideline recommended standard first-line therapy. Mesothelin antigen expression percentage \>＝10%. * 3\. Have at least one measurable target lesion. * 4\. Fresh solid tumor samples or formalin-fixed paraffin embedded tumor archival samples within 6 months are necessary; Fresh tumor samples are preferred. Subjects are willing to accept tumor rebiopsy in the process of this study. * 5\. Previous treatment must be completed for more than 4 weeks prior to the enrollment of this study, and subjects have recovered to \<= g |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Lead sponsor | Chinese PLA General Hospital |
| Locations | Beijing, Beijing Municipality, China |
| Start date | 2023-01-20 |
| NCT ID | NCT05693844 |
| Official listing | https://clinicaltrials.gov/study/NCT05693844 |