SCG142 TCR-T Cells for Human Papillomavirus-Associated Carcinomas

NCT06544720 — Phase 1, Recruiting, 18 participants, The Affiliated Hospital of Qingdao University

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

Registry	NCT06544720
Status	Recruiting
Phase	Phase 1
Study type	Interventional; na, single group, masking: none, treatment
Enrollment	18 (Estimated)
Sponsor	The Affiliated Hospital of Qingdao University (Other)
Conditions	Human Papillomavirus Associated Carcinomas, Cervical Cancer, Head and Neck Cancers, Anal Cancer, Vulva Cancer, Vaginal Cancer, Penile Cancer, HPV-Related Malignancy
Interventions	SCG142 TCR-T cells (Biological)
Dates	start 2023-08-02, primary completion 2025-12-31 (estimated), completion 2026-12-31 (estimated), first posted 2024-08-09, last updated 2024-08-09
Locations	1 site in China

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
SCG142 TCR-T cells	Experimental	Biological: SCG142 TCR-T cells	Monotherapy of SCG142

SCG142 TCR-T cells (Biological): Monotherapy of SCG142

+Outcome measures

Primary outcomes

DLT [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]: Assessed by RECIST 1.1 and iRECIST

+Eligibility

Sex: All, ages: 18 Years to any

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\&#39;s participation in this trial.

+Locations (1)

Facility	City	Country	Status
The affiliated hosptial of qingdao university	Qingdao, Shandong	China	Recruiting