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New treatment option for Cervical Cancer
Official title HRYZ-T101 Injection for HPV18 Positive Solid Tumor
ClinicalTrials.gov ID: NCT05952947
What this study is testing
What is HRYZ-T101 Injection?
HRYZ-T101 Injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for cervical cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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\. people who have failed anti-tumor treatment in the past and lack effective treatment options.
- 5\. HPV18 positive and HLA-DRB1\ 0901 allele.
You likely can't join if
- 1\. Have a history of hypersensitivity to cyclophosphamide or fludarabine, and it is known that any ingredient used in the treatment of this study...
- 2\. Those who have undergone systemic anti-tumor treatment within 4 weeks before apheresis, including who have received conventional chemotherapy...
- 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.
See the full eligibility 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\. people 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:
- Leukocytes≥3.0 x 10\^9/L;
- blood platelets ≥75 x 10\^9/L;
- hemoglobin≥85g/L;
- Absolute lymphocyte count≥0.8 x 10\^9/L
- Serum albumin ≥ 30g/L;
- total bilirubin≤1.5×ULN; ALT/AST≤3×ULN or ≤5×ULN for liver metastases;
- Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN;
- INR≤1.5×ULN; APTT≤1.5×ULN;
- LVEF≥50%;
- SpO2≥92%.
- 10\. people 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...
- 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...
- 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\. people with clinical cardiac symptoms or diseases that cannot be well controlled.
- 10\. people with serious or uncontrolled systemic disease or any unstable systemic disease.
- 11\. people with active infection requiring systemic treatment with anti-infective drugs within 2 weeks before apheresis.
- 12\. people 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\. people 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...
- 15\. people 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\. people 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.