Using SCG142 TCR-T cells to treat HPV-related cancers

A Phase 1 Clinical Study of Autologous TCR-T Cells (SCG142) Therapy for Advanced HPV Associated Carcinomas

This study is testing a new type of immune cell treatment called SCG142 TCR-T cells to see if it can help people with advanced cancers related to HPV.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 18 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: The Affiliated Hospital of Qingdao University (other)
• Locations: 1 site (Qingdao, Shandong)
• Trial ID: NCT06544720 on ClinicalTrials.gov

What this trial studies

This phase 1 clinical trial evaluates the safety, tolerability, and efficacy of SCG142 TCR-T cells in patients with advanced carcinomas associated with human papillomavirus (HPV). It is a multicenter, open-label study that involves a dose escalation and expansion approach to determine the optimal dosage and assess the treatment's effects on measurable lesions. The trial aims to provide insights into the potential of T cell receptor therapy for treating various HPV-related cancers, including cervical, head and neck, anal, and vulvar cancers.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with measurable lesions from HPV-associated carcinomas.

Not a fit: Patients with active autoimmune diseases or severe medical conditions that could limit participation may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could offer a novel therapeutic option for patients with advanced HPV-associated carcinomas.

How similar studies have performed: While this approach is innovative, similar studies using T cell receptor therapies have shown promise in treating other cancers, suggesting potential for success.

Eligibility 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.

Where this trial is running

Qingdao, Shandong

• The affiliated hosptial of qingdao university — Qingdao, Shandong, China (RECRUITING)

Study contacts

• Study coordinator: Hongying Lv

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