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 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07410494
Eligibility Criteria:
Inclusion Criteria:
* Age 18-75 years.
* Histologically or cytologically confirmed advanced/unresectable or metastatic solid tumor that is relapsed/refractory after standard therapy, or no standard therapy available.
* Targetable antigen positivity from the protocol target menu based on:
tissue biopsy and/or liquid biopsy platform (as defined in the lab manual).
* Arm assignment rules :
* Arm A: ≥1 antigen meets "positive" threshold
* Arm B: ≥2 antigens meet "positive" threshold
* ECOG performance status 0-1 (or 0-2 ).
* At least one measurable lesion by RECIST 1.1.
* Adequate organ function (hematologic, renal, hepatic, cardiac) within protocol-defined limits.
* Willingness to undergo blood draws and required biopsies (when medically feasible).
* Negative pregnancy test for participants of childbearing potential; agreement to effective contraception during and after study treatment.
Exclusion Criteria:
* Prior treatment with gene-modified cellular therapy (e.g., CAR-T, CAR-NK) within a defined washout period .
* Active, uncontrolled infection requiring IV antibiotics; known uncontrolled HIV; active HBV/HCV with detectable viral load (per local policy).
* Active CNS metastases requiring escalating steroids or urgent intervention (stable treated CNS disease may be allowed ).
* Active autoimmune disease requiring systemic immunosuppression, or chronic systemic steroids above protocol threshold.
* Clinically significant cardiovascular disease (e.g., recent MI, unstable arrhythmia), uncontrolled pulmonary disease, or other serious comorbidity that increases risk.
* Major surgery or anticancer therapy too close to lymphodepletion (protocol-defined washout).
* Pregnant or breastfeeding.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
8 Years
Maximum Age:
85 Years
Study:
NCT07410494
Study Brief:
Protocol Section:
NCT07410494