Engineered immune cells take on liver cancer in early trial

NCT ID NCT06515314

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 12 people

The number the study aims to enrol. It can still change while the study runs.

Started

Oct 2024

Expected to finish

Aug 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • Zhongshan Hospital Affiliated to Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, China

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