About this trial
A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Greater than or equal to 18 years of age
HPV associated carcinomas
Patients must have at least one measurable lesion defined by RECIST 1.1
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
Disqualifiers
Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.
Patients with active autoimmune diseases.
Patient has a known active Hepatitis B or Hepatitis C.
Other severe medical conditions that may limit subject's participation in this trial.
Trial design
Single group
Treatments tested in this trial
SCG142 TCR-T cells
Biological/VaccineMonotherapy of SCG142
Treatment groups
Trial outcomes
Primary outcomes
DLT
Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)
Secondary outcomes
Efficacy: antitumor activity of SCG142
Assessed by RECIST 1.1 and iRECIST
Sponsors and contacts
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