RecruitingPhase 1NCT06515314

HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors

A Phase 1, Single-arm, Open-label, Dose-escalation Study of AFP Specific T Cell Receptor Transduced T Cells Injection(HRYZ-T102)in Patients With AFP Positive Advanced Hepatocellular Carcinoma and Other Solid Tumors


Sponsor

Shanghai Ruiliyuan Biotechnology Co., Ltd.

Enrollment

12 participants

Start Date

Oct 17, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of HRYZ-T102 TCR-T Cell in patients with AFP positive advanced hepatocellular carcinoma and other solid tumors refractory to prior systematic treatments.


Eligibility

Min Age: 18 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing HRYZ-T102, a type of immune cell therapy (TCR-T cell therapy) engineered to recognize and attack cancer cells that produce a protein called AFP, in people with advanced liver cancer (hepatocellular carcinoma) or other solid tumors that test positive for AFP. **You may be eligible if...** - You are between 18 and 75 years old - You have a specific genetic marker called HLA-A 02:03 (detectable by blood test) - Your liver cancer or solid tumor has been confirmed AFP-positive by biopsy or blood test (AFP level at or above 400 ng/mL) - Your cancer is advanced stage (BCLC stage B or C for liver cancer) and not suitable for surgery - You have had at least one prior line of systemic treatment - Your physical performance is good (ECOG 0-1) and your liver function is adequate (Child-Pugh score 7 or below) **You may NOT be eligible if...** - You do not have the HLA-A 02:03 genetic marker - You have active autoimmune disease - You have had a prior organ transplant - You are pregnant or breastfeeding - Your organ function does not meet required levels 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

BIOLOGICALAFP Specific T Cell Receptor T Cells

AFP Specific T Cell Receptor T Cells On day 1, the TCR-T cells will be administered intravenously. Drug: Fludarabine + Cyclophosphamide Fludarabine: 25mg/m²/day×3days; Cyclophosphamide: 250mg/m²/day×3 days


Locations(1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

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NCT06515314


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