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

NCT ID: NCT06515314

Last Updated: 2025-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-17
• Study Completion Date: 2027-08-10

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.

Detailed Description

This study plans to enroll 12-24 patients to assess the safety of HRYZ-T102. Subjects who meet the eligibility criteria will receive a single dose of HRYZ-T102 injection .The patient will be followed up 24 months.

Conditions

Hepatic Cell Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

HRYZ-T102 Injection

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

Group Type: EXPERIMENTAL

AFP Specific T Cell Receptor T Cells

Intervention Type: 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

Interventions

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

Intervention Type: BIOLOGICAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Ruiliyuan Biotechnology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xiaowu Huang, Doctor

Role: PRINCIPAL_INVESTIGATOR

Study Principal Investigator

Locations

Zhongshan Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Wenjin Huang

Role: CONTACT

huangwenjin@shhryz.com

021-61049928

Facility Contacts

Xiaowu Huang, Doctor

Role: primary

Other Identifiers

H-T02-C1001

Identifier Type: -

Identifier Source: org_study_id