OncoMatch/Clinical Trials/NCT06718738
Clinical Study of IM96 CAR-T Cell Therapy in Patients With Advanced Colorectal Cancer
Is NCT06718738 recruiting? Yes, currently enrolling (Jun 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
Treatments studied
Other
Cancer type
Colorectal Cancer
Biomarker criteria
Required: GUCY2C positive expression (positive)
Disease stage
Metastatic disease required
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
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.
Frequently asked questions
Is NCT06718738 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior anti-GUCY2C therapy, cell therapy disqualifies patients from enrollment.
Does this trial require GUCY2C?
Yes, GUCY2C positive expression is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages