SuspendedEarly Phase 1

Autologous CAR-T Cells (WD-01) for Metastatic Colorectal Cancer

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

China30 participantsStarted 2025-05-18

Plain-language summary

This is an investigator initiated trial to assess the efficacy and safety of a GCC-targeting CAR-T therapy (WD-01) in the metastatic colorectal cancer.

Who can participate

Age range18 Years – 75 Years

SexALL

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Inclusion criteria

✓. ECOG performance status of 0-1 or KPS score \>70.
✓. Hematology parameters meeting: Hemoglobin (HB) ≥80 g/L, Absolute Neutrophil Count (ANC) ≥1.5 × 10\^9/L, Platelets (PLT) ≥80 × 10\^9/L, Lymphocytes (LY) ≥0.5 × 10\^9/L.
✓. Biochemistry parameters meeting: Total Bilirubin (TBIL) ≤2.0 × ULN (upper limit of normal); ALT and AST ≤2.5 × ULN; Serum Creatinine (Cr) ≤1 × ULN, Creatinine Clearance Rate \>40 mL/min (by Cockcroft-Gault formula).
✓. Left ventricular ejection fraction \>55%. 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 during the study and for 8 weeks after the last CAR-T administration (women who have undergone sterilization or have been postmenopausal for at least 2 years are considered not of childbearing potential).

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 WD-01 CAR-T cells through six months post-infusion

Trial details

NCT IDNCT06675513

SponsorWondercel Biotech (ShenZhen)

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-12-30

View on ClinicalTrials.gov More CRC (Colorectal Cancer) trials