NCT06358053

CRTE7A2-01 TCR-T Cells for HPV-16 Positive Advanced Cancers

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cells in HLA-A*02:01+ Subjects With HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers and Other Solid Tumors

• Status: Not Yet Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: Corregene Biotechnology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A single center, open, single arm dose escalation and dose expansion phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cells in HLA-A\*02:01+ Subjects HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine RP2D of CRTE7A2-01 TCR-T cell injection.

Conditions

• Cervical Cancer
• Anal Cancer
• Head and Neck Cancers
• Other Solid Tumors

Interventions

Type	Name	Description
DRUG	CRTE7A2-01 TCR-T cell therapy	Drug 1: Fludarabine + Cyclophosphamide Drug 2: Interleukin-2 Drug 3: CRTE7A2-01 TCR-T Cell

Timeline

• Start date: 2024-04-15
• Primary completion: 2027-12-31
• Completion: 2028-04-30
• First posted: 2024-04-10
• Last updated: 2024-04-10