SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

Qingdao University

Status and phase: Enrolling; Phase 1

Conditions: Anal Cancer; Penile Cancer; Human Papillomavirus Associated Carcinomas; Vaginal Cancer; Head and Neck Cancers; HPV-Related Malignancy; Vulva Cancer; Cervical Cancer

Treatments: Biological: SCG142 TCR-T cells

Study type: Interventional

Funder types: Other

Identifiers

NCT06544720

SCG142-CI-101

Details and patient eligibility

About

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.

Enrollment: 18 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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18 participants in 1 patient group

SCG142 TCR-T cells

Experimental group

Description:

Monotherapy of SCG142

Treatment:

Biological: SCG142 TCR-T cells