A Clinical Study on the Safety and Efficacy of Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma &Amp; Lung Cancer

Status: Recruiting
Location: See location...
Intervention Type: Biological
Study Type: Interventional
Study Phase: Early Phase 1
SUMMARY

This is an investigator initiated trial to assess the efficacy and safety of a GPC3-targeting CAR-T therapy (REVO-UWD-03) in the HCC and Lung Cancer. It also aims to explore the feasibility of using a novel universal CAR-T cell platform.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• Age: 18-80 years; Patients with histologically or cytologically confirmed, unresectable locally advanced or metastatic epithelial-derived malignant tumors who have failed standard treatments, have no available standard treatment options, or are unsuitable for standard treatments at the current stage, including but not limited to the following tumor types: non-small cell lung cancer or liver cancer; Immunohistochemistry (IHC) assessment shows GPC3 expression in ≥50% of the tumor lesion area with ≥1+ staining (assessment should be conducted on at least five randomly selected tumor regions, and at least five blank slides should be provided for evaluation); At least one measurable lesion; Estimated survival time of ≥90 days;

⁃ Normal major organ functions, meeting the following criteria: a. Absolute neutrophil count ≥1.5 x 10\^9/L; b. Platelet count ≥80 x 10\^9/L; c. Hemoglobin ≥9 g/dL; d. Liver function:

⁃ Total bilirubin ≤1.5 times the upper limit of normal (ULN), for Gilbert's syndrome patients, bilirubin ≤2.0 times ULN; Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 times ULN; e. International Normalized Ratio (INR) \<1.3 (for patients on anticoagulant therapy, INR \<3 is acceptable); f. Serum creatinine ≤1.5 mg/dL (132.6 μmol/L) or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m²; g. Left ventricular ejection fraction \>50%; No hemorrhagic disorders or coagulation dysfunctions; Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days before enrollment and be willing to use appropriate contraception during the study and for 8 weeks after the last CAR-T administration (women who have undergone sterilization or are postmenopausal for at least 2 years are considered not to have childbearing potential); The subject voluntarily agrees to participate in the study, signs the informed consent form, and demonstrates good compliance for follow-up.

Locations
Other Locations
China
First Affiliated Hospital of Xi'an Jiaotong University
RECRUITING
Xi'an
Contact Information
Primary
Clinical Deveopment Director
clinical@wondercel.com
+8618092039190
Time Frame
Start Date: 2024-10-23
Estimated Completion Date: 2027-12-30
Participants
Target number of participants: 60
Treatments
Experimental: Single dose injection of REVO-UWD-03
Dose escalation will be performed for the single dose injection of REVO-UWD-03 for treating HCC and NSCLC
Sponsors
Leads: Wondercel Biotech (ShenZhen)

This content was sourced from clinicaltrials.gov

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