Trials / Unknown
UnknownNCT05787535
HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor
A Phase I Study to Evaluate the Safety, Tolerance and Efficacy of HRYZ-T101 TCR-T Cell for HPV18 Positive Advanced Solid Tumor
- Status
- Unknown
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 17 (estimated)
- Sponsor
- HRYZ Biotech Co. · Industry
- Sex
- All
- Age
- 18 Years – 70 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 HRYZ-T101 TCR-T cell for HPV18 positive advanced solid tumor. The study will investigate DLT of HRYZ-T101 TCR-T cell injection.
Conditions
- Cervical Cancer
- Head and Neck Squamous Cell Carcinoma
- Oropharyngeal Cancer
- Vagina Tumor
- Carcinoma of Penis
- Anal Carcinoma
- Carcinoma of Vulva
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Fludarabine + Cyclophosphamide | Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days |
| BIOLOGICAL | HRYZ-T101 TCR-T Cell | On day 1, the TCR-T cells will be administered one time. |
Timeline
- Start date
- 2023-03-21
- Primary completion
- 2025-02-01
- Completion
- 2025-09-01
- First posted
- 2023-03-28
- Last updated
- 2024-02-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05787535. Inclusion in this directory is not an endorsement.