NCT05122221

CRTE7A2-01 TCR-T Cell for HPV-16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of CRTE7A2-01 TCR-T Cell for HPV16 Positive Advanced Cervical, Anal, or Head and Neck Cancers

• Status: Unknown
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 12 (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 phase I study to evaluate the safety, tolerability, and efficacy of CRTE7A2-01 TCR-T cell for HPV16 positive advanced cervical, anal, or head and neck cancers. The study will determine MTD of CRTE7A2-01 TCR-T cell injection, as well as investigate RP2D.

Conditions

• Cervical Cancer
• Anal Cancer
• Head and Neck Cancers

Interventions

Type	Name	Description
DRUG	Fludarabine + Cyclophosphamide	Fludarabine: 25mg/m²/day×3days Cyclophosphamide: 500mg/m²/day×3 days
DRUG	Interleukin-2	Interleukin-2 20,000,000 IU/time infused within 15 minutes approximately every 8 hours (according to the subject's tolerance, the interval between medications can be extended to 24 hours) for a maximum usage time up to 14 days.
BIOLOGICAL	CRTE7A2-01 TCR-T Cell	On day 0, the TCR-T cells will be administered one time, each bag of cell intravenously within 20 minutes.

Timeline

• Start date: 2022-07-17
• Primary completion: 2023-03-01
• Completion: 2024-12-01
• First posted: 2021-11-16
• Last updated: 2022-06-28

Locations

1 site across 1 country: China