HPV-Related Anal Squamous Cell Carcinoma, HPV-Related Cervical Squamous Cell Carcinoma, HPV-Related Head and Neck Cancer, HPV-Related Penile Squamous Cell Carcinoma, HPV-Related Squamous Cell Carcinoma, HPV-Related Vaginal Squamous Cell Carcinoma, HPV-Related Vulvar Squamous Cell Carcinoma
Conditions
Keywords
Human Papilloma Virus, HPV, Cervical Cancer, Head and Neck Cancer, Oropharyngeal Cancer, Vulvar Cancer, Vaginal Cancer, Penile Cancer, Anal Cancer, Anogenital Cancer, TCR T Cell, Cell therapy, T cell receptor T cell
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 therapy, including but not limited to combination chemotherapy and/or combination chemo-immunotherapy
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 Phase 2 part of the trial is designed to evaluate the preliminary efficacy of SCG142 in the same patient populations.
Interventions
BIOLOGICALSCG142
Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
DRUGCyclophosphamide
for 3 consecutive days
DRUGFludarabine
for 3 consecutive days
Sponsors
SCG Cell Therapy Pte. Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Treatment-Emergent Adverse Events (Phase 1) | 2 years | Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events. |
| Objective response rate (ORR) (Phase 2) | 2 years | The proportion of patients with a complete response (CR) or partial response (PR) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Disease control rate (DCR) (Phase 1&2) | 2 year | The proportion of patients with a CR, PR or stable disease (SD) |
| Progression-free survival (PFS) (Phase 1&2) | 2 year | The time from the date of the SCG142 administration to the first occurrence of a progressive disease (PD) or death from any cause |
| Objective response rate (ORR) (Phase 1) | 2 year | The proportion of patients with a complete response (CR) or partial response (PR) |
| Incidence of Treatment-Emergent Adverse Events (Phase 2) | 2 years | TEAEs |
| Overall survival (OS) (Phase 1&2) | 2 year | The time from date of the SCG142 administration to date of death of any cause |
| Duration of objective response (DOR) (Phase 1&2) | 2 year | The time from the first occurrence of a confirmed response to disease progression or death from any cause |
Contacts
Primary ContactSCG Cell Therapy
Outcome results
None listed