OncoMatch/Clinical Trials/NCT06718738
Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer
Is NCT06718738 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies IM96 CAR-T Cells for colorectal cancer (crc).
Treatment: IM96 CAR-T Cells — This study, a single-center, open, single-dose clinical study, was designed to evaluate the safety and efficacy of IM96 CAR-T cells in treating patients with advanced colorectal cancer
Check if I qualifyExtracted eligibility criteria
Cancer type
Colorectal Cancer
Biomarker criteria
Required: GUCY2C positive expression (positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Must have received: standard systemic therapy — second-line and above
Patients with metastatic colorectal cancer who have failed or are intolerant to second-line and above standard therapy
Cannot have received: anti-GUCY2C therapy
Exception: unless GUCY2C target test remains positive
Prior treatment with anti-GUCY2C target (unless GUCY2C target test remains positive)
Cannot have received: cell therapy (TCR-T therapy, CAR-T therapy)
received other cell therapy or genetically modified cell therapy in the past, such as TCR-T therapy, CAR-T therapy, etc
Lab requirements
Blood counts
Hemoglobin ≥ 90 g/L; ANC ≥ 1.5 x 10^9/L; Platelets ≥ 75 x 10^9/L; Absolute lymphocyte value ≥ 0.6 x 10^9/L; Lymphocytes ≥10% of WBC
Kidney function
creatinine clearance ≥60 ml/min
Liver function
ALT and AST ≤ 2.5 x ULN (≤ 5x ULN if explained by hepatic aggression); total bilirubin ≤ 1.5 x ULN (≤ 3x ULN if explained by hepatic aggression); serum albumin ≥ 3.0 g/dL
Cardiac function
Left ventricular ejection fraction ≥ 50% with a normal ECG or an abnormal ECG that, in the judgment of the investigator, does not require treatment; Prolongation of prothrombinogen time ≤ 4s; Oxygen saturation >92% in non-oxygenated state
Laboratory tests ... Hemoglobin (Hb) ≥ 90 g/L; Neutrophil count (ANC) ≥ 1.5 x 10^9/L; Platelet count (PLT) ≥ 75 x 10^9/L; Absolute lymphocyte value ≥ 0.6 x 10^9/L; Lymphocytes make up ≥10% of white blood cells; Creatinine clearance ≥60 ml/min; ALT and AST ≤ 2.5 x ULN ...; serum albumin ≥ 3.0 g/dL; Prolongation of prothrombinogen time ≤ 4s; Left ventricular ejection fraction ≥ 50% ...; Oxygen saturation >92% in non-oxygenated state
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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