SuspendedEarly Phase 1

Universal CAR-T Cells (REVO-UWD-03) for Advanced Hepatocellular Carcinoma and Lung Cancer

Stopped: Because the implementation of the new regulation policy by the Chinese authority

China60 participantsStarted 2024-10-23

Plain-language 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.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. Age: ≥18 years and ≤75 years;
✓. Patients with histologically or cytologically confirmed, unresectable locally advanced or metastatic epithelial-origin hepatocellular carcinoma (HCC) who have failed standard therapy, or for whom no standard therapy is available, or who are unsuitable for standard therapy at this stage;
✓. Hematology: Absolute neutrophil count ≥1.5 × 10⁹/L; platelets ≥80 × 10⁹/L; hemoglobin ≥9.0 g/dL;
✓. Liver function: Total bilirubin ≤5 × upper limit of normal (ULN); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤5 × ULN;
✓. Renal function: Serum creatinine ≤5 × ULN or estimated glomerular filtration rate (eGFR) ≥50 mL/min/1.73 m²;
✓. Coagulation: Prothrombin time (PT) prolongation ≤4 seconds;
✓. Cardiac function: Left ventricular ejection fraction (LVEF) \>50%; 8. No hemorrhagic disorders or coagulopathy; 9. Women of childbearing potential must have a negative pregnancy test (serum or urine) within 7 days prior to enrollment, and agree to use appropriate contraception from enrollment through 8 weeks after the last CAR-T administration (women who have undergone sterilization or been postmenopausal for at least 2 years are considered not of childbearing potential); 10. Voluntary participation in the study, signed informed consent, good compliance, and willingness to complete follow-up.

Exclusion criteria

✕. Pregnant or breastfeeding women;
✕. Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection;

What they're measuring

Maximum Tolerated Dose (MTD)

Timeframe: Within the first month post-infusion

Dose-Limiting Toxicities (DLT)

Timeframe: Within the first month post-infusion.

Treatment-Emergent Adverse Events (TEAE)

Timeframe: From the administration of UWD-03 CAR-T cells through six months post-infusion

Trial details

NCT IDNCT06653023

SponsorWondercel Biotech (ShenZhen)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-10-20

View on ClinicalTrials.gov More HCC - Hepatocellular Carcinoma trials