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 range
18 Years
Sex
ALL
See this in plain English?
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Treatment-Emergent Adverse Events (Phase 1)