Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
Launched by SCG CELL THERAPY PTE. LTD. · Jul 10, 2024
Trial Information
Current as of July 09, 2025
Not yet recruiting
Keywords
ClinConnect Summary
This clinical trial is testing a new treatment called SCG142 TCR T cells for patients with certain types of advanced cancers related to human papillomavirus (HPV), specifically those that are positive for HPV16 or HPV52. These cancers can include cervical, head and neck, anal, penile, vulvar, and vaginal squamous cell carcinoma. The trial is designed for patients whose cancer has not responded to at least one previous standard treatment, which could include chemotherapy or a combination of chemotherapy and immunotherapy.
To participate in this trial, patients need to have a confirmed diagnosis of squamous cell carcinoma that is advanced or has spread, and their tumor must test positive for HPV16 or HPV52. Participants should also have a measurable disease and a good performance status, meaning they are generally healthy enough to participate. The trial will not be recruiting participants just yet, but it aims to offer a new treatment option for those who have limited choices left. Throughout the trial, participants will receive the SCG142 treatment and will be monitored for its effectiveness and any side effects.
Gender
ALL
Eligibility criteria
- Main Inclusion Criteria:
- • 1. Histologically confirmed squamous cell carcinoma (SCC); may include any of the following tumor types: cervical, head and neck, anal, penile, vulvar, or vaginal.
- • 2. Tumor tissue positive for HPV16 or HPV52.
- • 3. 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.
- • 4. Human leukocyte antigen (HLA)-A\*02:01 genotype.
- • 5. Measurable disease as defined by RECIST v1.1.
- • 6. Eastern Cooperative Group (ECOG) Performance Status of 0 or 1.
- • 7. Anticipated life expectancy ≥3 months.
- • 8. Adequate laboratory parameters including hematologic, renal, hepatic and coagulation function.
- Main Exclusion Criteria:
- • 1. 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.
- • 2. Active brain metastasis or leptomeningeal metastases.
- • 3. History of other malignancy within 2 years prior to Screening.
- • 4. History of organ transplant.
- • 5. Positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome (AIDS).
- • 6. History of active cardiac disease.
- • 7. History of active pulmonary disease.
- • 8. Active, known, or suspected autoimmune disease.
- • 9. Lack of peripheral venous or central venous access, or any condition that may prevent trial sample collection and administration of SCG142.
- • 10. 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.
- • 11. Allergy to LD chemotherapy (cyclophosphamide or fludarabine) and/or any component of SCG142.
- • 12. Any serious medical condition or abnormality in clinical laboratory tests.
About Scg Cell Therapy Pte. Ltd.
SCG Cell Therapy Pte. Ltd. is a pioneering clinical trial sponsor dedicated to advancing innovative cell-based therapies for the treatment of various diseases. With a strong focus on research and development, the company leverages cutting-edge technology and scientific expertise to design and conduct rigorous clinical trials that aim to evaluate the safety and efficacy of its therapeutic products. Committed to improving patient outcomes, SCG Cell Therapy collaborates with leading research institutions and healthcare professionals to drive the translation of groundbreaking research into effective treatment options, ultimately contributing to the next generation of regenerative medicine.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Trial Officials
SCG Cell Therapy
Study Director
SCG Cell Therapy Pte. Ltd.
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported