HRYZ-T101 Injection for HPV18 Positive Solid Tumor

Trial Title: HRYZ-T101 Injection for HPV18 Positive Solid Tumor

NCT ID: NCT05952947

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

Conditions: Official terms:
Carcinoma
Squamous Cell Carcinoma of Head and Neck
Anus Neoplasms
Vulvar Neoplasms
Vaginal 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: Biological
Intervention name: HRYZ-T101 Injection
Description: On day 1, the TCR-T cells will be administered intravenously.
Arm group label: HRYZ-T101 Injection

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

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.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1. The patient must be willing to sign the informed consent form. - 2. Age ≥18 years and ≤75 years. - 3. Metastatic or recurrent solid tumors with confirmed HPV18 infection based on TNM & FIGO staged histopathological investigation. . - 4. Subjects who have failed anti-tumor treatment in the past and lack effective treatment options. - 5. HPV18 positive and HLA-DRB1*0901 allele. - 6. ECOG performance status ≤1. - 7. Estimated life expectancy ≥ 3 months. - 8. Patients must have at least one measurable lesion defined by RECIST 1.1. - 9. Patients with any organ dysfunction as defined below: 1. Leukocytes≥3.0 x 10^9/L; 2. blood platelets ≥75 x 10^9/L; 3. hemoglobin≥85g/L; 4. Absolute lymphocyte count≥0.8 x 10^9/L 5. Serum albumin ≥ 30g/L; 6. total bilirubin≤1.5×ULN; ALT/AST≤3×ULN or ≤5×ULN for liver metastases; 7. Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN; 8. INR≤1.5×ULN; APTT≤1.5×ULN; 9. LVEF≥50%; 10. SpO2≥92%. - 10. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T101 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis. Exclusion Criteria: - 1. 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. - 2. 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. - 3. Have received any investigational drug within 4 weeks before apheresis, or have participated in another clinical study at the same time. - 4. Have received any cell therapy products before. - 5. Those who have undergone major surgery within 4 weeks before apheresis, or minor surgery within 2 weeks before apheresis. - 6. Toxicity of previous treatment has not been mitigated or ≤ Grade 1 before apheresis. - 7. Have received live attenuated vaccine or adenovirus vector vaccine within 4 weeks before apheresis. - 8. Have central nervous system metastasis with symptoms. - 9. Subjects with clinical cardiac symptoms or diseases that cannot be well controlled. - 10. Subjects with serious or uncontrolled systemic disease or any unstable systemic disease. - 11. Subjects with active infection requiring systemic treatment with anti-infective drugs within 2 weeks before apheresis. - 12. Subjects have any active autoimmune disease or history of autoimmune disease. - 13. Have received immunosuppressive agents, or systemic corticosteroids, immunomodulators within 2 weeks before apheresis. - 14. Subjects with other malignant tumors. Except for: (1) Carcinoma in situ with curative treatment and no evidence of recurrence for at least 2 years; (2) the primary malignant tumor has been completely resected and achieved CR for ≥ 2 years. - 15. Subjects with history of thromboembolism ≥ Grade 3 within 6 months before apheresis, or is receiving thrombolytic or anticoagulant for high-risk of thromboembolism. - 16. Known HIV or syphilis infection, and/or active hepatitis B virus or hepatitis C virus infection. - 17. Organ transplanters and allogeneic cell transplanters. - 18. Subjects with active pulmonary tuberculosis infection within 1 year or have not received treatment at least 1 year before apheresis. - 19. Pregnant or lactating female, or those whose HCG test is positive before enrollment. - 20. 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: 75 Years

Healthy volunteers: No

Locations:

Facility:
Name: Fudan University Shanghai Cancer Center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Xuemin Rao
Email: raoxuemin@shhryz.com

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

Investigator:
Last name: Xiaohua Wu, Doctor
Email: Principal Investigator

Start date: November 1, 2023

Completion date: February 2028

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/NCT05952947