Phase I Clinical Study of YK1101 Injection for the Treatment of Advanced Solid Tumors
ConditionAdvanced Solid Tumor Cancer
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-75
SponsorPeking University
About this trial
A single-arm, open-label, dose exploratory study to evaluate the safety, efficacy, and pharmacokinetics of autologous humanized anti-MAGE-A4 T cell receptor-engineered T cell (TCR-T) in advanced solid tumors.
Eligibility criteria
Qualifiers
Voluntarily willing to participate in the study and sign the written informed consent form
Age ≥18 years and ≤75 years,male or female .
Human leukocyte antigen (HLA)-A*11:01 matched
Fresh or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry(IHC)-stained MAGE-A4 positive（+2，≥30%）
Disqualifiers
Pregnant or lactating women.
HIV, treponema pallidum or HCV serology is positive.
Patients with any uncontrolled active infection, including, but not limited to, active tuberculosis or HBV infection (HBsAg positive or HBV DNA positive).
Patients with symptomatic central nervous metastases.
Trial design
Treatments tested in this trial
- YK1101 cells
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Peking University
Lead sponsor
Yingkai Saiwei（Beijing）Biotechnology Co., Ltd
Collaborator
Source ClinicalTrials.gov