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NCT Number: NCT06544720

SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

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.

Recruiting

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Key information

Conditions

Human Papillomavirus Associated Carcinomas Anal Cancer Anus Diseases Anus Neoplasms Cervical Cancer Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Diseases, Male Genital Neoplasms, Female Genital Neoplasms, Male HPV-Related Malignancy Head and Neck Cancers Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Male Urogenital Diseases Neoplasms Neoplasms by Site Penile Cancer Penile Diseases Penile Neoplasms Rectal Diseases Rectal Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms Vaginal Cancer Vaginal Diseases Vaginal Neoplasms Vulva Cancer Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

The affiliated hosptial of qingdao university

Qingdao, Shandong, 266071, China

Location status: Recruiting

Location contact

Hongying Lv

CONTACT

[email protected]

18661805217

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

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

Key Exclusion Criteria:

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

Treatment and study plan

SCG142 TCR-T cells

Biological

Monotherapy of SCG142

Primary outcomes

  1. DLT

    Time frame: 28 days

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

Secondary outcomes

  1. Efficacy: antitumor activity of SCG142

    Time frame: 2 years

    Assessed by RECIST 1.1 and iRECIST

Study contacts

Contact information is provided by the study sponsor or research team.

Hongying Lv

CONTACT

[email protected]

+86 18661805217

Sponsors and collaborators

Lead sponsor

The Affiliated Hospital of Qingdao University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2025
Study completion
2026
First posted
Aug 9, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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