HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor

Trial Title: HRYZ-T101 TCR-T Cell for HPV-18 Positive Advanced Solid Tumor

NCT ID: NCT05787535

Condition: Cervical Cancer
Head and Neck Squamous Cell Carcinoma
Oropharyngeal Cancer
Vagina Tumor
Carcinoma of Penis
Anal Carcinoma
Carcinoma of Vulva

Conditions: Official terms:
Carcinoma
Squamous Cell Carcinoma of Head and Neck
Oropharyngeal Neoplasms
Anus Neoplasms
Vulvar Neoplasms
Cyclophosphamide
Fludarabine

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: Fludarabine + Cyclophosphamide
Description: Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days
Arm group label: HRYZ-T101 TCR-T cell therapy

Intervention type: Biological
Intervention name: HRYZ-T101 TCR-T Cell
Description: On day 1, the TCR-T cells will be administered one time.
Arm group label: HRYZ-T101 TCR-T cell therapy

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: 1. The patient must be willing to sign the informed consent form. 2. Age ≥18 years and ≤70 years. 3. Histologically-confirmed advanced metastatic or recurrent solid tumors with confirmed HPV18 infection and HLA-DRB1*09:01 allele. 4. Subjects who have failed at least first-line treatment in the past and lack effective treatment options. 5. ECOG performance status of 0-1. 6. Estimated life expectancy ≥ 3 months. 7. Patients must have at least one measurable lesion defined by RECIST 1.1. 8. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 6 months after receiving HRYZ-T101 cell transfusion treatment. 9. Patients with any organ dysfunction as defined below: 1) Leukocytes≥3.0 x 10^9/L; 2) absolute neutrophil count ≤1.5 x 10^9/L; 3) blood platelets ≥75 x 10^9/L; 4) hemoglobin≥90g/L; 5) Serum albumin ≥ 3.0g/dL; 6) total bilirubin≤1.5×ULN; ALT/AST≤2.5×ULN; 7) Creatinine clearance ≥50mL/min; 8) INR≤1.5×ULN; APTT≤1.5×ULN; 9) LVEF≥50%; 10) SpO2≥92%. Exclusion Criteria: 1. Organ transplanters and allogeneic cell transplanters. 2. 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. 3. Those who have undergone major surgery within 4 weeks before enrollment, and those who have received conventional chemotherapy, large-area radiotherapy, targeted therapy, endocrine therapy, immunotherapy or biological therapy, and Chinese herbal medicine and other anti-tumor treatment. 4. Have received live attenuated vaccine within 4 weeks before enrollment. 5. Subjects with clinical cardiac symptoms or diseases that cannot be well controlled. 6. The subject has active infection or fever more than 38.5 degrees of unknown cause during screening and before cell transfusion. 7. Subjects have any active autoimmune disease or history of autoimmune disease. 8. Subjects with other malignant tumors. 9. Patients with central nervous system metastasis. 10. Active, uncontrolled bacterial or fungal infection requiring systemic treatment. 11. Known HIV or syphilis infection, and/or active hepatitis B virus or hepatitis C virus infection. 12. It is planned to use immunosuppressive agents, or systemic corticosteroids, immunomodulators. 13. Have received any investigational drug within 4 weeks before enrollment, or have participated in another clinical study at the same time. 14. Pregnant or lactating subjects, or those who are unwilling to contraception during the test. 15. Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure. 16. Other serious organic diseases and mental disorders. 17. Have received any gene therapy products before. 18. According to the judgment of the researcher, those who are not suitable for the group, such as poor compliance.

Gender: All

Minimum age: 18 Years

Maximum age: 70 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Zip: 200120
Country: China

Status: Recruiting

Contact:
Last name: Shuang Hao
Email: haoshuang@shhryz.com

Investigator:
Last name: Jian Zhang, Doctor
Email: Principal Investigator

Start date: March 21, 2023

Completion date: September 2025

Lead sponsor:
Agency: HRYZ Biotech Co.
Agency class: Industry

Source: HRYZ Biotech Co.

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05787535