Engineered immune cells take on liver cancer in early trial
NCT ID NCT06515314
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This early-phase trial is testing a new treatment for advanced liver cancer that has not responded to standard therapies. The treatment uses a patient's own immune cells, which are genetically modified to recognize and attack cancer cells that produce a protein called AFP. Twelve participants will receive the modified cells along with chemotherapy to see if the approach is safe and to find the best dose.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- AFP-specific TCR-T cells (genetically modified immune cells) plus chemotherapy (fludarabine and cyclophosphamide)
- What this could lead to
- If it works, this could point toward a new treatment option for advanced liver cancer that has stopped responding to other therapies.
- What could go wrong
- This is a very early Phase 1 trial with only 12 participants, so it is primarily checking safety and dosing. The treatment may not shrink tumors, and there are risks from both the cell therapy and the chemotherapy.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Aug 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Zhongshan Hospital Affiliated to Fudan University
RECRUITINGShanghai, Shanghai Municipality, China
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