A Phase 1/2 Open Label, Single Arm, Multicenter Study to Evaluate the Safety and Preliminary Eficacy of Autologous SCG142 T Cell Receptor (TCR) T Cells in Patients With Advanced or Metastatic HPV16- or HPV52-positive Carcinomas
Overview
- Phase
- Phase 1
- Intervention
- SCG142
- Conditions
- HPV-Related Squamous Cell Carcinoma
- Sponsor
- SCG Cell Therapy Pte. Ltd.
- Enrollment
- 66
- Primary Endpoint
- Incidence of Treatment-Emergent Adverse Events (Phase 1)
- Status
- Not yet recruiting
- Last Updated
- last year
Overview
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.
Investigators
Eligibility Criteria
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 HPV
- •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.
- •Eastern Cooperative Group (ECOG) Performance Status of 0 or
- •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.
- •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 SCG
- •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.
Arms & Interventions
SCG142 T cells
This is a single arm study.
Intervention: SCG142
SCG142 T cells
This is a single arm study.
Intervention: Cyclophosphamide
SCG142 T cells
This is a single arm study.
Intervention: Fludarabine
Outcomes
Primary Outcomes
Incidence of Treatment-Emergent Adverse Events (Phase 1)
Time Frame: 2 years
Incidence of dose-limiting toxicities (DLTs) and occurrence of study related adverse events.
Objective response rate (ORR) (Phase 2)
Time Frame: 2 years
The proportion of patients with a complete response (CR) or partial response (PR)
Secondary Outcomes
- Objective response rate (ORR) (Phase 1)(2 year)
- Duration of objective response (DOR) (Phase 1&2)(2 year)
- Disease control rate (DCR) (Phase 1&2)(2 year)
- Progression-free survival (PFS) (Phase 1&2)(2 year)
- Overall survival (OS) (Phase 1&2)(2 year)
- Incidence of Treatment-Emergent Adverse Events (Phase 2)(2 years)