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Clinical Trials/NCT06544720
NCT06544720
Recruiting
Phase 1

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

The Affiliated Hospital of Qingdao University1 site in 1 country18 target enrollmentAugust 2, 2023
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ConditionsHuman Papillomavirus Associated CarcinomasCervical CancerHead and Neck CancersAnal CancerVulva CancerVaginal CancerPenile CancerHPV-Related Malignancy

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Human Papillomavirus Associated Carcinomas
Sponsor
The Affiliated Hospital of Qingdao University
Enrollment
18
Locations
1
Primary Endpoint
DLT
Status
Recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar TrialsRelated News

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2, 2023
End Date
December 31, 2026
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

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.

Outcomes

Primary Outcomes

DLT

Time Frame: 28 days

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

Secondary Outcomes

  • Efficacy: antitumor activity of SCG142(2 years)

Study Sites (1)

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Related News

SCG142 Demonstrates 100% Disease Control Rate in First-in-Human Trial for HPV-Associated Cancers- SCG Cell Therapy reported that all seven patients treated with SCG142, an HPV E7-specific TCR T cell therapy, experienced tumor shrinkage in a Phase I trial for recurrent or metastatic HPV-associated carcinomas. - Four patients (57%) achieved greater than 30% tumor reduction, including two confirmed partial responses and two unconfirmed partial responses, with no dose-limiting toxicities reported. - The therapy targets HLA-A*02:01-positive patients with advanced HPV16- or HPV52-positive carcinomas who have progressed on prior systemic therapy. - Results were presented at the European Society for Medical Oncology Congress 2025, supporting continued clinical development of this novel TCR T cell therapy platform.