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New treatment option for Hepatic Cell Carcinoma
Official title HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
ClinicalTrials.gov ID: NCT06515314
What this study is testing
What is AFP Specific T Cell Receptor T Cells?
AFP Specific T Cell Receptor T Cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for hepatic cell carcinoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- 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...
- Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained AFP positive or serum AFP ≥400ng/ml.
You likely can't join if
- 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...
- Current presence of or previously with hepatic encephalopathy
See the full eligibility 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...
- 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 ≤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...
- people 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...
- 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
- Have central nervous system metastasis with symptoms
- Known HIV or syphilis infection, and/or active hepatitis C virus infection.
- HBV infect people 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
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.