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OncoMatch/Clinical Trials/NCT06653023

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

Is NCT06653023 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies multiple treatments including Universal CAR-T cells and MMF Immunosuppression for hcc - hepatocellular carcinoma.

Early Phase 1RecruitingWondercel Biotech (ShenZhen)NCT06653023Data as of May 2026

Treatment: Universal CAR-T cells · MMF ImmunosuppressionThis 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.

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Extracted eligibility criteria

Cancer type

Hepatocellular Carcinoma

Non-Small Cell Lung Carcinoma

Biomarker criteria

Required: GPC3 overexpression (IHC ≥1+ in ≥50% of tumor lesion area)

Immunohistochemistry (IHC) evaluation showing GPC3 expression ≥1+ in ≥50% of the tumor lesion area

Disease stage

Required: Stage III, IV, BCLC STAGE B, BCLC STAGE C, CNLC STAGE IIB, CNLC STAGE III (BCLC, CNLC)

(1) Barcelona Clinic Liver Cancer (BCLC) stage B (not amenable to hepatic surgery and/or other local therapies, or disease progression after local therapy) or stage C; (2) Or China Liver Cancer (CNLC) stage IIb or III (not amenable to hepatic surgery and/or other local therapies, or disease progression after local therapy)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: standard therapy

who have failed standard therapy, or for whom no standard therapy is available, or who are unsuitable for standard therapy at this stage

Cannot have received: chemotherapy

Exception: within 14 days prior to cell collection

Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection

Cannot have received: targeted therapy

Exception: within 14 days prior to cell collection

Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection

Cannot have received: monoclonal antibody

Exception: within 14 days prior to cell collection

Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection

Cannot have received: investigational drug

Exception: within 14 days prior to cell collection

Received chemotherapy, targeted therapy, other investigational drugs, or monoclonal antibody therapy within 14 days prior to cell collection

Cannot have received: investigational drug

Exception: participated in another drug clinical trial within 4 weeks prior to study initiation

Participated in another drug clinical trial within 4 weeks prior to study initiation

Lab requirements

Blood counts

Absolute neutrophil count ≥1.5 × 10⁹/L; platelets ≥80 × 10⁹/L; hemoglobin ≥9.0 g/dL

Kidney function

Serum creatinine ≤5 × ULN or eGFR ≥50 mL/min/1.73 m²

Liver function

Total bilirubin ≤5 × ULN; AST and ALT ≤5 × ULN

Cardiac function

LVEF >50%

Adequate major organ function, meeting the following criteria: Hematology: Absolute neutrophil count ≥1.5 × 10⁹/L; platelets ≥80 × 10⁹/L; hemoglobin ≥9.0 g/dL; Liver function: Total bilirubin ≤5 × ULN; AST and ALT ≤5 × ULN; Renal function: Serum creatinine ≤5 × ULN or eGFR ≥50 mL/min/1.73 m²; Coagulation: PT prolongation ≤4 seconds; Cardiac function: LVEF >50%

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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