SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

Phase 1

Recruiting

• Conditions: Anal Cancer; HPV-Related Malignancy; Cervical Cancer; Vulva Cancer; Penile Cancer; Human Papillomavirus Associated Carcinomas; Head and Neck Cancers; Vaginal Cancer
• Interventions: Biological: SCG142 TCR-T cells

• Registration Number: NCT06544720
• Lead Sponsor: The Affiliated Hospital of Qingdao University

Brief Summary

A multicenter, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of SCG142 TCR-T cells in Subjects with advanced HPV associated carcinomas.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-08-02
• Status Verified: 2024-08
• Study First Submitted: 2024-08-06
• Study First Submitted QC: 2024-08-06
• Last Update Submitted: 2024-08-06
• Study First Posted: 2024-08-09
• Last Update Posted: 2024-08-09
• Primary Completion: 2025-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

1. Greater than or equal to 18 years of age
2. HPV associated carcinomas
3. Patients must have at least one measurable lesion defined by RECIST 1.1
4. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

Key

Exclusion Criteria

1. Active or uncontrollable infections or other active major medical illnesses of the cardiovascular, respiratory.
2. Patients with active autoimmune diseases.
3. Patient has a known active Hepatitis B or Hepatitis C.
4. Other severe medical conditions that may limit subject's participation in this trial.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SCG142 TCR-T cells	SCG142 TCR-T cells	Monotherapy of SCG142

Primary Outcome Measures

Name	Time	Method
DLT	28 days	Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)

Secondary Outcome Measures

Name	Time	Method
Efficacy: antitumor activity of SCG142	2 years	Assessed by RECIST 1.1 and iRECIST

Trial Locations

Locations (1)

The affiliated hosptial of qingdao university; 🇨🇳 Qingdao, Shandong, China