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

HRYZ Biotech Co.1 site in 1 country32 target enrollmentNovember 1, 2023

ConditionsCervical Cancer Head and Neck Squamous Cell Carcinoma Carcinoma of Vagina Carcinoma of Penis Anal Cancer Carcinoma of Vulva

InterventionsFludarabine + Cyclophosphamide HRYZ-T101 Injection

DrugsFludarabine + Cyclophosphamide

Overview

Phase: Phase 1
Intervention: Fludarabine + Cyclophosphamide
Conditions: Cervical Cancer
Sponsor: HRYZ Biotech Co.
Enrollment: 32
Locations: 1
Primary Endpoint: DLT
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 1, 2023

End Date

February 2028

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

HRYZ Biotech Co.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•The patient must be willing to sign the informed consent form.
•Age ≥18 years and ≤75 years.
•Metastatic or recurrent solid tumors with confirmed HPV18 infection based on TNM \& FIGO staged histopathological investigation. .
•Subjects who have failed anti-tumor treatment in the past and lack effective treatment options.
•HPV18 positive and HLA-DRB1\*0901 allele.
•ECOG performance status ≤
•Estimated life expectancy ≥ 3 months.
•Patients must have at least one measurable lesion defined by RECIST 1.
•Patients with any organ dysfunction as defined below:
•Leukocytes≥3.0 x 10\^9/L;

Exclusion Criteria

•Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study will produce allergic reactions.
•Those who have undergone systemic anti-tumor treatment within 4 weeks before apheresis, including who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, immunotherapy or biological therapy, and other anti-tumor treatment. Have received small molecule targeted drugs and oral fluorouracils or Chinese herbal medicine within 2 weeks before apheresis.
•Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time.
•Have received any cell therapy products before.
•Those who have undergone major surgery within 4 weeks before apheresis, or minor surgery within 2 weeks before apheresis.
•Toxicity of previous treatment has not been mitigated or ≤ Grade 1 before apheresis.
•Have received live attenuated vaccine or adenovirus vector vaccine within 4 weeks before apheresis.
•Have central nervous system metastasis with symptoms.
•Subjects with clinical cardiac symptoms or diseases that cannot be well controlled.
•Subjects with serious or uncontrolled systemic disease or any unstable systemic disease.