RecruitingPhase 1NCT05952947

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


Sponsor

HRYZ Biotech Co.

Enrollment

32 participants

Start Date

Nov 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an immune cell therapy called HRYZ-T101 in people with HPV18-positive solid tumors (cancers infected with the human papillomavirus type 18) that have stopped responding to standard treatments. This therapy uses the patient's own immune cells that are trained to recognize and attack HPV18-infected cancer cells. **You may be eligible if...** - You are 18 to 75 years old with confirmed HPV18-positive solid cancer (such as cervical cancer) that is recurrent or metastatic - Your cancer has not responded to prior treatments and there are no other effective options - You carry a specific immune protein type called HLA-DRB1*0901 - Your overall health (ECOG ≤1) and organ function are adequate **You may NOT be eligible if...** - You have received prior cell therapy - You are HIV positive, have active hepatitis B or C, or syphilis - You have active autoimmune disease - You have had active tuberculosis in the past year - You have symptomatic brain metastases - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICALHRYZ-T101 Injection

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

DRUGFludarabine + Cyclophosphamide

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


Locations(1)

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

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NCT05952947


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