Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Digestive System Diseases

Rare Diseases

Uterine Cervical Neoplasms

Carcinoma

Carcinoma, Squamous Cell

Vaginal Neoplasms

Vulvar Neoplasms

Anus Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Genital Neoplasms, Female

Urogenital Neoplasms

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Head and Neck Neoplasms

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Anus Diseases

Rectal Diseases

Vulvar Diseases

Vaginal Diseases

Vaginal Cancer

Penile Cancer

Anal Cancer

Vulvar Cancer

Antineoplastic Agents

Antirheumatic Agents

All Drugs and Chemicals

Cyclophosphamide

Fludarabine

Fludarabine phosphate

Immunosuppressive Agents

Immunologic Factors

Antineoplastic Agents, Alkylating

Alkylating Agents

Patients will undergo lymphocytapheresis, then treatment with HRYZ-T101 TCR-T cells.

On day 1, the TCR-T cells will be administered intravenously.

HRYZ-T101 Injection

Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days

Fludarabine + Cyclophosphamide

Xuemin Rao

Jian Zhang, Doctor

Xiaohua Wu, Doctor

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.

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

Serum samples will be collected to analyze for the presence of ADAs using validated immunoassays.

RCL exposure will be assessed by polymerase chain reaction (PCR) based assay.

Collect blood samples and analyze for T cell subgroup by flow cytometry at specified intervals before and after treatment with HRYZ-T101.

Incidence of adverse events and serious adverse events

The percentage of subjects with PR or CR assessed by RECIST 1.1.

The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.

Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.

Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.

The length of time from enrollment until the time of progression of disease.

The interval of time between the date of T-cell infusion and the date of death.

Blood samples were collected to measure persistence of infused HRYZ-T101.

Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T101.

HRYZ Biotech Co.

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Oropharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Patients will undergo lymphocytapheresis, then treatment with TCR-T cell.

On day 1, the TCR-T cells will be administered one time.

HRYZ-T101 TCR-T Cell

Shuang Hao

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.

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

The length of time from the first appearance of a treatment response to the first occurrence of progressive disease or recurrence.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
HRYZ-T101 Injection for HPV18 Positive Solid Tumor	NCT05952947	Cervical Cancer Head and Neck S... Carcinoma of Va... Carcinoma of Pe... Anal Cancer Carcinoma of Vu...	HRYZ-T101 Injec... Fludarabine + C...	18 Years - 75 Years	HRYZ Biotech Co.
HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor	NCT05787535	Cervical Cancer Head and Neck S... Oropharyngeal C... Vagina Tumor Carcinoma of Pe... Anal Carcinoma Carcinoma of Vu...	Fludarabine + C... HRYZ-T101 TCR-T...	18 Years - 70 Years	HRYZ Biotech Co.

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