Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma (NCT06505551) | Clinical Trial Compass
Not Yet RecruitingPhase 1/2
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
66 participantsStarted 2024-10
Plain-language summary
This is a phase 1/2, open-label, single arm, multicenter study in patients with advanced or metastatic HPV16- or HPV52-positive carcinomas who have progressed after at least one line of systemic therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
✓. Tumor tissue positive for HPV16 or HPV52.
✓. Advanced or metastatic carcinoma with progression after at least 1 line of standard of care systemic therapies, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy.
✓. Human leukocyte antigen (HLA)-A\*02:01 genotype.
✓. Measurable disease as defined by RECIST v1.1.
✓. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
✓. Anticipated life expectancy ≥3 months.
✓. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.
Exclusion criteria
✕. Presence of clinically relevant or active seizure disorder, stroke, cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or any autoimmune disease with central nervous system (CNS) involvement.
✕. Active brain metastasis or leptomeningeal metastases.
✕. History of other malignancy within 2 years prior to Screening.
✕. History of organ transplant.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (Phase 1)