Trials / Recruiting
RecruitingNCT05952947
HRYZ-T101 Injection for HPV18 Positive Solid Tumor
A Multicenter, Single Arm, Open Label, Phase I Clinical Study to Evaluate the Safety, Tolerability and Efficacy of HRYZ-T101 Injection for HPV18 Positive Solid Tumor
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 32 (estimated)
- Sponsor
- HRYZ Biotech Co. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, open label, single arm dose escalation phase I study to evaluate the safety, tolerability, and efficacy of HRYZ-T101 injection for HPV18 positive solid tumor. The study will investigate RP2D of HRYZ-T101 TCR-T cell injection.
Conditions
- Cervical Cancer
- Head and Neck Squamous Cell Carcinoma
- Carcinoma of Vagina
- Carcinoma of Penis
- Anal Cancer
- Carcinoma of Vulva
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HRYZ-T101 Injection | On day 1, the TCR-T cells will be administered intravenously. |
| DRUG | Fludarabine + Cyclophosphamide | Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days |
Timeline
- Start date
- 2023-11-01
- Primary completion
- 2027-12-01
- Completion
- 2028-02-01
- First posted
- 2023-07-19
- Last updated
- 2024-02-02
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05952947. Inclusion in this directory is not an endorsement.