GPC3-directed CAR-T in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma

Recruiting now · Not applicable

Conditions studied: Hepatocellular Carcinoma

In brief

This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous armored GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refractory to prior systematic treatments.

Key facts

Study ID: NCT05926726
Run by: RenJi Hospital
People needed: 12
Starts: 2023-01-01
Expected to finish: 2026-12-31
Last updated by the study team: 2023-07-03

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

18-75 years-old, male or female
Voluntarily willing to participate in the study and sign the written informed consent form
Life expectation ≥12 weeks
Eastern Cooperative Oncology Group (ECOG) performance status scale ≤1
Histologically-confirmed hepatocellular carcinoma (HCC)
No benefits from curative surgery or other local therapies are expected at screening, judged by investigators
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
Fresh samples or FFPE, immunohistochemistry (IHC)-stained GPC-3 positive with intensity ++ or +++
Per RECIST v1.1, at least one measurable lesion
Manageable lung metastasis
Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
No active HBV infections
Adequate organ functions
Adequate venous access for APH
Non-hematological AEs induced by previous treatment must have recovered to CTCAE ≤1, except for alopecia and peripheral neuropathy
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
Women of childbearing potential must have negative serum β-hCG test result at screening and 48 hours prior to lymphodepletion

You may not qualify if…

Cholangiocarcinoma or histological-mixed hepatocellular cholangiocarcinoma
Active brain metastasis
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
Another primary malignancy within 3 years (with some exceptions for completely-resected early-stage tumors)
Systematic autoimmune disorders requiring long-term systematic immunosuppression
Previously treated with any genetically engineered modified T cell therapy (TCR-T/CAR-T) or other CGT
Active HCV, HIV, or syphilis
History of organ transplant
Uncontrolled or active infection at screening, prior to APH, 72 hours prior to lymphodepletion or 5 days prior to JWATM214 infusion
With severe cardiovascular disease
History or presence of clinically-relevant CNS disorders
Current presence of hepatic encephalopathy
≥G2 hemorrhage within 30 days prior to screening, or in need of long-term anticoagulants
Active digestive ulcer or gastrointestinal bleeding within 3 months prior to screening
Pregnant or lactating women
Not satisfying wash-out period for APH
Unable or unwilling to comply with the study protocol, judged by the investigator
Other situations implying that the subject might not be appropriate to participate in the study
Previously allergic or intolerable to JWATM214 or its components

Where it is running

Ren Ji Hospital, School of Medicine, Shanghai Jiao Tong University — Shanghai, China (enrolling)

Full record on ClinicalTrials.gov

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