Actively Recruiting
HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
Led by Shanghai Ruiliyuan Biotechnology Co., Ltd. · Updated on 2025-12-02
12
Participants Needed
1
Research Sites
146 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
HRYZ-T102 TCR-T Cell for AFP Positive Advanced HCC and Other Solid Tumors
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willingness to sign informed consent
- Age 18 to 75 years
- Positive for HLA-A 02:03 allele
- Histologically confirmed AFP positive hepatocellular carcinoma or other solid tumor
- No expected benefit from surgery or local therapies
- At least one prior line of systemic treatment
- AFP positive confirmed by immunohistochemistry or serum AFP ≥ 400 ng/ml
- Barcelona Clinic Liver Cancer (BCLC) stage B or C and Child-Pugh score ≤ 7
- ECOG performance status ≤ 1
- Estimated life expectancy of at least 4 months
- At least one measurable lesion per RECIST 1.1
- Adequate organ function including leukocytes ≥ 3.0 x 10^9/L, platelets ≥ 75 x 10^9/L, hemoglobin ≥ 85 g/L, absolute lymphocyte count ≥ 0.8 x 10^9/L, serum albumin ≥ 30 g/L, total bilirubin ≤ 3×ULN, ALT/AST ≤ 3×ULN, creatinine clearance ≥ 50 mL/min, serum creatinine ≤ 1.5×ULN, INR ≤ 1.5×ULN, APTT ≤ 1.5×ULN, LVEF ≥ 50%, SpO2 ≥ 92%
- Agreement to use effective contraception during the trial and for 1 year after treatment
- Negative HCG test for females with potential fertility within 7 days before apheresis
You will not qualify if you...
- Unresolved toxicity from prior treatment greater than Grade 1
- Another primary cancer within 5 years except certain resected early-stage tumors
- Severe cardiovascular disease or clinically relevant CNS disorders within 6 months
- Systemic autoimmune disorders requiring long-term immunosuppression
- History of hypersensitivity to cyclophosphamide or fludarabine or related ingredients
- Current or prior hepatic encephalopathy
- Organ or allogeneic cell transplant recipients
- History or recent risk of gastrointestinal bleeding within 3 months
- Hereditary or acquired bleeding disorders or clotting tendencies
- Active infection or unexplained fever at screening
- CNS metastasis with symptoms
- Known HIV, syphilis, or active hepatitis C infection
- HBV infection with HBV-DNA ≥ 2000 IU/ml
- Pregnant or breastfeeding women or positive HCG test before enrollment
- Uncontrolled diabetes, pulmonary fibrosis, interstitial lung disease, acute lung disease, or liver failure
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Zhongshan Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, China
Actively Recruiting
Research Team
W
Wenjin Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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