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

NCT06515314 | Recruiting Phase 1

• 1 other identifier: H-T02-C1001
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatic Cell Carcinoma

Outcome Measures

Primary Outcomes (2)

• Adverse events and serious adverse events

  Incidence of adverse events and serious adverse events

  2 years

• DLT

  Dose-limiting toxicity

  2 years

Secondary Outcomes (8)

• Objective Response Rate（ORR）

  2 years

• Disease Control Rate (DCR)

  2 years

• Duration of response (DoR)

  2 years

• Time to response (TTR)

  2 years

• Progression-Free Survival（PFS）

  2 years

Other Outcomes (3)

• Number of Subjects with positive anti-drug antibodies (ADA)

  2 years

• Number of subjects with replication competent lentivirus (RCL)

  2 years

• T cell subgroup in peripheral blood

  2 years

Study Arms (1)

HRYZ-T102 Injection

EXPERIMENTAL

Patients will undergo lymphocytapheresis, then treatment with HRYZ-T102 TCR-T cells.

Biological: AFP Specific T Cell Receptor T Cells

Interventions

AFP Specific T Cell Receptor T Cells BIOLOGICAL

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

HRYZ-T102 Injection

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• The patient must be willing to sign the informed consent form.
• Age ≥18 years and ≤75 years.
• HLA-A 02:03 allele positive
• 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.
• Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml.
• Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
• ECOG performance status ≤1.
• Estimated life expectancy ≥4 months.
• Patients must have at least one measurable lesion defined by RECIST 1.1.
• 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%.
• 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.

You may not qualify if:

• Toxicity of previous treatment has not been mitigated or ≤ Grade 1 at screening.
• Another primary malignancy within 5 years (with some exceptions for completely-resected early-stage tumors)
• With severe cardiovascular disease or presence of clinically-relevant central nervous system (CNS) disorders in six months before screening.
• Systematic autoimmune disorders requiring long-term systematic immunosuppression
• 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.
• Current presence of or previously with hepatic encephalopathy
• Organ transplanters and allogeneic cell transplanters.
• Have a history of gastrointestinal bleeding or a definite tendency to gastrointestinal bleeding within 3 months before screening
• Hereditary or acquired bleeding (e.g. coagulation dysfunction) or a tendency to clot
• Subject has active infection or unexplained fever during screening and prior to cell transfusion
• Have central nervous system metastasis with symptoms
• Known HIV or syphilis infection, and/or active hepatitis C virus infection.
• HBV infect subjects with HBV-DNA≥2000IU/ml
• Pregnant or lactating female, or those whose HCG test is positive before enrollment.
• Known uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease or liver failure

Sponsors & Collaborators

• Shanghai Ruiliyuan Biotechnology Co., Ltd.: lead

Study Sites (1)

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

RECRUITING

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Xiaowu Huang, Doctor

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wenjin Huang

CONTACT

021-61049928; huangwenjin@shhryz.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 17, 2024
• First Posted: July 23, 2024
• Study Start: October 17, 2024
• Primary Completion (Estimated): August 10, 2026
• Study Completion (Estimated): August 10, 2027
• Last Updated: December 2, 2025

Record last verified: 2025-11

Locations

CN (1)