Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-26 @ 3:15 PM
NCT ID:
NCT07462650
Eligibility Criteria:
Inclusion Criteria:
* Histologically confirmed colorectal adenocarcinoma that is unresectable or metastatic and has progressed after, is intolerant to, or is ineligible for standard therapies.
* Measurable disease per RECIST v1.1 (unless in minimal residual disease (MRD) or post-resection cohorts if a future amendment is planned).
* Tumor antigen co-expression meeting central lab thresholds for one of the following pairs: CEA+GUCY2C, CEA+HER2, or GUCY2C+HER2.
* ECOG performance status 0-1.
* Adequate organ function (hematologic, renal, hepatic, and cardiac) as defined in protocol.
* Recovered to Grade \<=1 from prior therapy-related toxicities (except stable Grade 2 neuropathy or alopecia).
* Life expectancy \>= 12 weeks.
* Willingness to use effective contraception during study and for a protocol-defined period after cell infusion.
Exclusion Criteria:
* Active, uncontrolled infection (including uncontrolled HBV/HCV) or known uncontrolled HIV infection.
* Active CNS metastases that are symptomatic or require escalating steroids. (Stable treated CNS disease may be allowed per protocol.)
* Prior gene-modified cellular therapy (CAR-T/CAR-NK/TCR-T) within 6 months, or any prior therapy that in the investigator's judgment increases risk of severe toxicity.
* Clinically significant autoimmune disease requiring systemic immunosuppression within the past 6 months.
* Concurrent anti-cancer therapy (other than protocol-permitted bridging) during the DLT window.
* Pregnant or breastfeeding.
* Significant cardiovascular disease (e.g., recent MI, uncontrolled arrhythmia), uncontrolled pulmonary disease, or other severe comorbidity that would increase risk.
* Known hypersensitivity to study chemotherapy components (fludarabine/cyclophosphamide) or required supportive medications.
* Any condition that, in the investigator's opinion, would interfere with study participation, safety monitoring, or interpretation of results.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT07462650
Study Brief:
Protocol Section:
NCT07462650