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:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-24 @ 11:38 PM
NCT ID:
NCT05001451
Eligibility Criteria:
Inclusion Criteria:
* ≥ 18 years old
* Weight ≥ 40 kg
* Anticipated life expectancy \> 3 months prior to lymphodepletion
* Karnofsky Performance Score ≥ 70%
* Histologically confirmed diagnosis of AML
* In complete response (CR) (including CRi/CRp); patients in first, second or subsequent CR (including CRi/CRp) are permitted
* MRD detected in bone marrow by MFC
* Negative pregnancy test (females of childbearing potential only)
* Agree to use effective birth control
* Left ventricular ejection fraction (LVEF) ≥ 50%
* Platelet Count ≥ 20 x 109/L
* Prothrombin Time or INR ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
* Partial Thromboplastin Time ≤ 1.5 x ULN (unless receiving therapeutic anticoagulation)
* Hemoglobin ≥ 8.0 g/dL
* Creatinine Clearance ≥ 40mL/min
* Serum Total Bilirubin ≤ 1.5 x ULN (unless documented Gilbert's Syndrome with Direct Bilirubin \< 35% of Total Bilirubin)
* ALT ≤ 2.5 x ULN
Exclusion Criteria:
* Cytotoxic chemotherapy within 3 weeks
* Immune therapy within 4 weeks
* Immunosuppressive therapy within 2 weeks (with exceptions)
* Investigational treatment or interventional clinical trial within 4 weeks or 5 half-lives (if known), whichever is longer
* Major surgery within 4 weeks and/or not fully recovered from surgery-related toxicities
* Known hypersensitivity to chemotherapy, other agents, or excipients used in this study
* Female patient that is pregnant or lactating/breastfeeding
* Ongoing toxicity from prior anti-cancer therapy that have not recovered to ≤ Grade 1 (with exceptions)
* History of chronic or recurrent autoimmune or immune-mediated disease requiring steroids or other immunosuppressive treatments (including anti-tumor necrosis factor agents)
* Active CNS involvement (i.e. leukemic infiltration)
* Any other malignancy that requires active therapy
* Uncontrolled intercurrent illness (i.e. acute coronary syndrome in the last 6 months)
* Active infection with HIV, Hepatitis B or Hepatitis C
NOTE: other protocol defined inclusion/exclusion criteria may apply.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05001451
Study Brief:
Protocol Section:
NCT05001451