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

Shanghai Ruiliyuan Biotechnology Co., Ltd.1 site in 1 country12 target enrollmentOctober 17, 2024

ConditionsHepatic Cell Carcinoma

InterventionsAFP Specific T Cell Receptor T Cells

Overview

Phase: Phase 1
Intervention: AFP Specific T Cell Receptor T Cells
Conditions: Hepatic Cell Carcinoma
Sponsor: Shanghai Ruiliyuan Biotechnology Co., Ltd.
Enrollment: 12
Locations: 1
Primary Endpoint: Adverse events and serious adverse events
Status: Recruiting
Last Updated: 5 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 17, 2024

End Date

August 10, 2027

Last Updated

5 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Shanghai Ruiliyuan Biotechnology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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 ≤
•Estimated life expectancy ≥4 months.
•Patients must have at least one measurable lesion defined by RECIST 1.
•Patients with any organ dysfunction as defined below:

Exclusion Criteria

•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