GPC3-directed CAR-T therapy for advanced liver cancer
JWATM214，an Armored GPC3-directed CAR-T ，in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma ：a Single-arm, Open-label，Dose-escalation Study
This study is testing a new CAR-T therapy for advanced liver cancer to see if it can help patients who haven't responded to other treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 12 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | RenJi Hospital Academic / other |
| Drugs / interventions | CAR-T |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT05926726 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the safety and efficacy of autologous armored GPC3-directed CAR-T cells in patients with advanced hepatocellular carcinoma who have not responded to previous treatments. It is a single-arm, open-label, dose escalation study, meaning all participants will receive the treatment without a control group. The study aims to determine how well this innovative therapy can target and attack cancer cells in patients with specific characteristics of liver cancer. Participants will be closely monitored for their response to the treatment and any potential side effects.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-75 with advanced hepatocellular carcinoma that has progressed after prior treatments.
Not a fit: Patients with active HBV infections or those who are not expected to benefit from further treatment options may not receive benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with advanced liver cancer who have limited alternatives.
How similar studies have performed: While CAR-T therapies have shown promise in other cancers, this specific approach targeting GPC3 in hepatocellular carcinoma is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 18-75 years-old, male or female 2. Voluntarily willing to participate in the study and sign the written informed consent form 3. Life expectation ≥12 weeks 4. Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1 5. Histologically-confirmed hepatocellular carcinoma (HCC) 6. No benefits from curative surgery or other local therapies are expected at screening, judged by investigators 7. Radiologically-confirmed progression disease after at least one prior line of systematic treatment and limited benefits from current guideline or consensus for hepatocellular carcinoma are expected at screening, judged by investigators 8. Fresh samples or FFPE, immunohistochemistry (IHC)-stained GPC-3 positive with intensity ++ or +++ 9. Per RECIST v1.1, at least one measurable lesion 10. Manageable lung metastasis 11. Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7 12. No active HBV infections 13. Adequate organ functions 14. Adequate venous access for APH 15. Non-hematological AEs induced by previous treatment must have recovered to CTCAE ≤1, except for alopecia and peripheral neuropathy 16. Women of childbearing potential must agree to use an effective and reliable contraceptive method during 28 days prior to lymphodepletion to 1 year post infusion; Male patients who have not undergone vasectomy and have sexual activity with women of childbearing potential must agree to the use of a barrier contraceptive method since lymphodepletion to 1year post infusion, and sperm donation is prohibited during the study 17. Women of childbearing potential must have negative serum β-hCG test result at screening and 48 hours prior to lymphodepletion Exclusion Criteria: 1. Cholangiocarcinoma or histological-mixed hepatocellular cholangiocarcinoma 2. Active brain metastasis 3. Primary lesion or infused lesions with the longest diameter ≥15cm, or other potential risk which might not be appropriate for further study treatment judged by the investigator 4. Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors) 5. Systematic autoimmune disorders requiring long-term systematic immunosuppression 6. Previously treated with any genetically engineered modified T cell therapy (TCR-T/CAR-T) or other CGT 7. Active HCV, HIV, or syphilis 8. History of organ transplant 9. Uncontrolled or active infection at screening, prior to APH, 72 hours prior to lymphodepletion or 5 days prior to JWATM214 infusion 10. With severe cardiovascular disease 11. History or presence of clinically-relevant CNS disorders 12. Current presence of hepatic encephalopathy 13. ≥G2 hemorrhage within 30 days prior to screening, or in need of long-term anticoagulants 14. Active digestive ulcer or gastrointestinal bleeding within 3 months prior to screening 15. Pregnant or lactating women 16. Not satisfying wash-out period for APH 17. Unable or unwilling to comply with the study protocol, judged by the investigator 18. Other situations implying that the subject might not be appropriate to participate in the study 19. Previously allergic or intolerable to JWATM214 or its components
Where this trial is running
Shanghai
- Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Hao Feng, MD.,Ph.D. — Dept. Liver Surgery, Renji Hospital, School of Medicine, SJTU
- Study coordinator: Hao Feng, MD.,Ph.D
- Email: surgeonfeng@live.com
- Phone: 008615000901110
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.