NCT06505551

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

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

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: SCG Cell Therapy Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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

Type	Name	Description
BIOLOGICAL	SCG142	Autologous SCG142 cells infused on Day 0 after completion of lymphedepletion chemotherapy
DRUG	Cyclophosphamide	for 3 consecutive days
DRUG	Fludarabine	for 3 consecutive days

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-12-01
• Completion: 2028-12-01
• First posted: 2024-07-17
• Last updated: 2024-07-17

Regulatory

• FDA-regulated drug study