Status:
UNKNOWN
A Phase 1, Single-arm, Open-label, Dose-escalation Study of JWATM204 as T Cell-targeted Immunotherapy in the Treatment Amongst Subjects With Advanced Hepatocellular Carcinoma
Lead Sponsor:
Shanghai Ming Ju Biotechnology Co., Ltd.
Conditions:
Liver Carcinoma
Hepatic Cell Carcinoma
Eligibility:
All Genders
18-75 years
Phase:
PHASE1
Brief Summary
This is a single arm, open-label, dose escalation clinical study to evaluate the safety and efficacy of infused autologous GPC3-directed CAR-T in patients with advanced hepatocellular carcinoma refrac...
Eligibility Criteria
Inclusion
- 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 available options for hepatocellular carcinoma are expected at screening, judged by investigators
- Fresh samples or formalin-fixed paraffin-embedded (FFPE) samples, immunohistochemistry (IHC)-stained GPC-3 positive
- Per RECIST v1.1, at least one measurable lesion
- Barcelona Clinic Liver Cancer (BCLC) stage C or B and Child-Pugh ≤7
- No active infections of hepatitis B virus
- Adequate organ functions
- Adequate venous access for apheresis
- 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-human chorionic gonadotropin (β-hCG) test result at screening and 48 hours prior to lymphodepletion
Exclusion
- Active brain metastasis
- Primary lesion or infused lesions with the longest diameter ≥15 cm, 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 nor other cell-gene therapy
- Active infections of hepatitis C virus (HCV), human immunodeficiency virus (HIV), or syphilis
- Uncontrolled or active infection at screening, prior to apheresis, 72 hours prior to lymphodepletion or 5 days prior to JWATM204 infusion
- With severe cardiovascular disease History or presence of clinically-relevant central nervous system (CNS) disorders
- With clinically-significant CNS disorders
- Current presence of or previously with hepatic encephalopathy
- ≥G2 hemorrhage within 30 days prior to screening, or in need of long-term anticoagulants
- Pregnant or lactating women
- Not satisfying pre-defined wash-out period for apheresis
- Received plasma exchange within 14 days prior to apheresis
- Unable or unwilling to comply with the study protocol, judged by the investigator, or other situations implying that the subject might not be appropriate to participate in the study
- Vaccinated with live vaccinations against infectious diseases within 8 weeks prior to JWATM204 infusion
- Previously allergic or intolerable to JWATM204 or its components
Key Trial Info
Start Date :
March 24 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06144385
Start Date
March 24 2022
End Date
December 1 2024
Last Update
January 2 2024
Active Locations (1)
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1
Tao Zhang
Wuhan, Hubei, China, 430022