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Clinical Trials in China / NCT06515314
Recruiting Phase 1

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

NCT06515314 · tracked via the Priya Life Science China tracker
Sponsor
Shanghai Ruiliyuan Biotechnology Co., Ltd.
Phase
Phase 1
Started
2024-10-17
Last updated
2025-12-02

Condition(s) studied

Hepatic Cell Carcinoma

Investigational drug(s) / intervention(s)

AFP Specific T Cell Receptor T Cells

AFP 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

Study 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

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria: 1. The patient must be willing to sign the informed consent form. 2. Age ≥18 years and ≤75 years. 3. HLA-A 02:03 allele positive 4. Histologically-confirmed AFP positive hepatocellular carcinoma (HCC) or other solid tumor, No benefits from curative surgery or other local therapies are expected ,at least one prior line of systematic treatment at screening, judged by investigators. 5. Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml. 6. Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7 7. ECOG performance status ≤1. 8. Estimated life expectancy ≥4 months. 9. Patients must have at least one measurable lesion defined by RECIST 1.1. 10. 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≤3×ULN; ALT/AST≤3×ULN ; Creatinine clearance ≥50mL/min; or serum creatinine ≤1.5×ULN; INR≤1.5×ULN; APTT≤1.5×ULN; LVEF≥50%; SpO2≥92%. 11. Subjects with potential fertility must agree to use effective contraceptive methods during the whole trials period and at least 1 year after receiving HRYZ-T102 cell transfusion treatment. HCG test for female with potential fertility must be negative within 7 days before apheresis. Exclusion Criteria: 1. Toxicity of previous treatment has not been mitigated or ≤ Grade 1 at screening. 2. Another primary malignancy within 5 years (with some exceptions for completely-resected early-stage tumors) 3. With severe cardiovascular disease or presence of clinically-relevant central nervous system (CNS) disorders in six months before screening. 4. Systematic autoimmune disorders requiring long-term systematic immunosuppression 5. 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. 6. Current presence of or previously with hepatic encephalopathy 7. Organ transplanters and allogeneic cell transplanters. 8. Have a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 3 months before screening 9. Hereditary or acquired bleeding (e.g. coagulation dysfunction) or a tendency to clot 10. Subject has active infection or unexplained fever during screening and prior to cell transfusion 11. Have central nervous system metastasis with symptoms 12. Known HIV or syphilis infection, and/or active hepatitis C virus infection. 13. HBV infect subjects with HBV-DNA≥2000IU/ml 14. Pregnant or lactating female, or those whose HCG test is positive before enrollment. 15. Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Zhongshan Hospital Affiliated to Fudan University Shanghai Shanghai Municipality Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06515314 on ClinicalTrials.gov ↗ ← All trials in China