Phase 1/2 Study of Autologous SCG142 TCR T Cells in Patients With HPV16/52-positive Carcinoma

Phase 1

Not yet recruiting

• 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
• Interventions: Biological: SCG142; Drug: Cyclophosphamide; Drug: Fludarabine

• Registration Number: NCT06505551
• Lead Sponsor: SCG Cell Therapy Pte. Ltd.

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.

Study Timeline

• Status Verified: 2024-07
• Study First Submitted: 2024-07-01
• Study First Submitted QC: 2024-07-10
• Last Update Submitted: 2024-07-10
• Study First Posted: 2024-07-17
• Last Update Posted: 2024-07-17
• Study Start: 2024-10
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 66

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCG142 T cells	SCG142	This is a single arm study.
SCG142 T cells	Cyclophosphamide	This is a single arm study.
SCG142 T cells	Fludarabine	This is a single arm study.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Objective response rate (ORR) (Phase 1)	2 year	The proportion of patients with a complete response (CR) or partial response (PR)
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
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
Overall survival (OS) (Phase 1&2)	2 year	The time from date of the SCG142 administration to date of death of any cause
Incidence of Treatment-Emergent Adverse Events (Phase 2)	2 years	TEAEs