Hepatic Cell CarcinomaPhase 1NCT06515314
HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
A Phase 1 study testing AFP Specific T Cell Receptor T Cells in people with Hepatic Cell Carcinoma, run by Shanghai Ruiliyuan Biotechnology Co., Ltd. at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hepatic Cell Carcinoma
- What is being tested?
- AFP Specific T Cell Receptor T Cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 17 Oct 2024to 10 Aug 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality
Xiaowu Huang, Doctor
About this study
Official title: 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
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.
Read the 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
- Being tested
- AFP Specific T Cell Receptor T Cells
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AFP Specific T Cell Receptor T CellsBiological
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 group | Role | What they receive |
|---|---|---|
| HRYZ-T102 Injection | Experimental | Patients will undergo lymphocytapheresis, then treatment with HRYZ-T102 TCR-T cells. Receives: Biological: AFP Specific T Cell Receptor T Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events and serious adverse events
Incidence of adverse events and serious adverse events
Measured: 2 years
DLT
Dose-limiting toxicity
Measured: 2 years
Secondary outcomes (8)
Objective Response Rate（ORR）
The percentage of subjects with PR or CR assessed by RECIST 1.1.
Measured: 2 years
Disease Control Rate (DCR)
The percentage of subjects with a confirmed CR, PR, or stable disease (SD) assessed by RECIST 1.1.
Measured: 2 years
Duration of response (DoR)
Subjects who show a confirmed CR or PR as assessed by RECIST 1.1.
Measured: 2 years
Time to response (TTR)
Time from date of T-cell administration to first documented evidence of confirmed (CR or PR) as assessed by RECIST 1.1.
Measured: 2 years
Progression-Free Survival（PFS）
The length of time from enrollment until the time of progression of disease
Measured: 2 years
Overall Survival (OS)
The interval of time between the date of T-cell infusion and the date of death.
Measured: 2 years
Duration of TCR T cells in-vivo persistence
Blood samples were collected to measure persistence of infused HRYZ-T102
Measured: 2 years
Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)
Collect blood samples and analyze for presence of cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ) at specified intervals before and after treatment with HRYZ-T102.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2024
- Study start17 Oct 2024
- Primary completion10 Aug 2026 (estimated)
- Study completion10 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatic Cell CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ruiliyuan Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xiaowu Huang, Doctor, Principal investigator, Study Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06515314
- Sponsor's protocol ID
- H-T02-C1001
- Status last verified
- Nov 2025
- First submitted
- 17 Jul 2024
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06515314
- Acronym / sponsor ID
- H-T02-C1001
- Conditions
- Hepatic Cell Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Shanghai Ruiliyuan Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Oct 2024 (actual)
- Primary completion
- 10 Aug 2026 (estimated)
- Study completion
- 10 Aug 2027 (estimated)
- First posted
- 23 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRYZ-T102 Injection | Experimental | Biological: AFP Specific T Cell Receptor T CellsPatients will undergo lymphocytapheresis, then treatment with HRYZ-T102 TCR-T cells. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AFP Specific T Cell Receptor T CellsAFP 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 | Biological | HRYZ-T102 Injection |
Primary outcome
Adverse events and serious adverse events
Time frame: 2 years
Incidence of adverse events and serious adverse events
DLT
Time frame: 2 years
Dose-limiting toxicity
8 secondary outcomes
Objective Response Rate（ORR）
Time frame: 2 years
Disease Control Rate (DCR)
Time frame: 2 years
Duration of response (DoR)
Time frame: 2 years
Time to response (TTR)
Time frame: 2 years
Progression-Free Survival（PFS）
Time frame: 2 years
Overall Survival (OS)
Time frame: 2 years
Duration of TCR T cells in-vivo persistence
Time frame: 2 years
Concentration of Cytokines (IL-2、IL-6、IL-10、TNFα、IFNγ)
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaowu Huang, Doctor principal investigator
Study Principal Investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing AFP Specific T Cell Receptor T Cells in people with Hepatic Cell Carcinoma, run by Shanghai Ruiliyuan Biotechnology Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjin Huang (021-61049928, huangwenjin@shhryz.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events and serious adverse events (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2025.