HRYZ-T101 Injection for HPV18 Positive Solid Tumor
NCT05952947 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 32
Last updated 2024-02-02
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
- 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
Sponsors & Collaborators
-
HRYZ Biotech Co.
lead INDUSTRY
Principal Investigators
-
Xiaohua Wu, Doctor · Fudan University
-
Jian Zhang, Doctor · Fudan University
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-01
- Primary Completion
- 2027-12-31
- Completion
- 2028-02-29
Countries
- China
Study Locations
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