Clinical trial NCT06505551: Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
PHASE2
Conditions: HPV-Related Squamous Cell Carcinoma
HPV-Related Cervical Squamous Cell Carcinoma
HPV-Related Vulvar Squamous Cell Carcinoma
HPV-Related Penile Squamous Cell Carcinoma
HPV-Related Vaginal Squamous Cell Carcinoma
HPV-Related Anal Squamous Cell Carcinoma
HPV-Related Head and Neck Cancer
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
Lead sponsor: SCG Cell Therapy Pte. Ltd.
Sponsor class: INDUSTRY
First posted: 2024-07-17
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events (Phase 1)
timeFrame: 2 years
measure: Objective response rate (ORR) (Phase 2)
timeFrame: 2 years
Secondary outcomes:
measure: Objective response rate (ORR) (Phase 1)
timeFrame: 2 year
measure: Duration of objective response (DOR) (Phase 1&2)
timeFrame: 2 year
measure: Disease control rate (DCR) (Phase 1&2)
timeFrame: 2 year
measure: Progression-free survival (PFS) (Phase 1&2)
timeFrame: 2 year
measure: Overall survival (OS) (Phase 1&2)
timeFrame: 2 year
measure: Incidence of Treatment-Emergent Adverse Events (Phase 2)
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: SCG Cell Therapy Pte. Ltd.
name: SCG Cell Therapy
role: STUDY_DIRECTOR
References: