Status:
NOT_YET_RECRUITING
Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
Lead Sponsor:
SCG Cell Therapy Pte. Ltd.
Conditions:
HPV-Related Squamous Cell Carcinoma
HPV-Related Cervical Squamous Cell Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 thera...
Detailed Description
This study will be conducted in 2 parts: The Phase 1 part of the trial consists of a dose-escalation portion designed to evaluate the safety and tolerability of SCG142, and to identify the RP2D. The...
Eligibility Criteria
Inclusion
- Main
- 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.
- Main
Exclusion
- 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.
- Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- History of active cardiac disease.
- History of active pulmonary disease.
- Active, known, or suspected autoimmune disease.
- Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
- Prior exposure to any cell therapy including, but not limited to natural killer (NK) cells, cytokine-induced killer (CIK) cells, dendritic cells (DCs), cytotoxic T lymphocytes (CTLs), stem cell therapy, and CAR/TCR-T cell therapy.
- Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
- Any serious medical condition or abnormality in clinical laboratory tests.
Key Trial Info
Start Date :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
66 Patients enrolled
Trial Details
Trial ID
NCT06505551
Start Date
October 1 2024
End Date
December 1 2028
Last Update
July 17 2024
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