SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

NCT06544720 | Recruiting Phase 1

• 1 other identifier: SCG142-CI-101
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• DLT

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

  28 days

Secondary Outcomes (1)

• Efficacy: antitumor activity of SCG142

  2 years

Study Arms (1)

SCG142 TCR-T cells

EXPERIMENTAL

Monotherapy of SCG142

Biological: SCG142 TCR-T cells

Interventions

SCG142 TCR-T cells BIOLOGICAL

Monotherapy of SCG142

SCG142 TCR-T cells

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• The Affiliated Hospital of Qingdao University: lead

Study Sites (1)

The affiliated hosptial of qingdao university

Qingdao, Shandong, 266071, China

RECRUITING

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Head and Neck Neoplasms; Anus Neoplasms; Vulvar Neoplasms; Vaginal Neoplasms; Penile Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Rectal Neoplasms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Intestinal Diseases; Anus Diseases; Rectal Diseases; Vulvar Diseases; Vaginal Diseases; Genital Neoplasms, Male; Genital Diseases, Male; Penile Diseases; Male Urogenital Diseases

Central Study Contacts

Hongying Lv

CONTACT

+86 18661805217; qdlhytiger@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 6, 2024
• First Posted: August 9, 2024
• Study Start: August 2, 2023
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 9, 2024

Record last verified: 2024-08

Locations

CN (1)