SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

Phase 1RecruitingNCT06544720

The Affiliated Hospital of Qingdao University18 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Human Papillomavirus Associated Carcinomas Cervical Cancer Head and Neck Cancers Anal Cancer Vulva Cancer Vaginal Cancer

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Key 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.

Outcomes

Primary Outcomes

DLT

Number of subjects with adverse events (AEs) and laboratory abnormalities defined as dose limiting toxicities (DLT)

Time frame: 28 days

Secondary Outcomes

Efficacy: antitumor activity of SCG142

Assessed by RECIST 1.1 and iRECIST

Time frame: 2 years