Phase I Trial of CLEc12a (CD371) Targeted ArmoRed Immune Effector Cells in Patients With Relapsed/Refractory Acute Myeloid Leukemia (CLEAR-AML)
Memorial Sloan Kettering Cancer Center
Summary
The purpose of this study is to find out whether CD371-YSNVZ-IL18 CAR T cells are safe, and to look for the highest dose of CD371-YSNVZ-IL18 CAR T cells that cause few or mild side effects in participants.
Eligibility
- Age range
- 1+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: Subject Inclusion: Collection of T cells (Part A) * History of CD371+ AML * Any disease status is eligible for collection * Expression of CD371 at any level on AML blasts (any method of detection including IHC and/or flow cytometry) * Age/Weight * Pediatrics: ≥ 1 year and ≥ 10kg for collection * Adults: no limit on age/weight for collection * Patients with history of allo-HCT are eligible for collection if: * ≥ 100 days post-transplant * no evidence of active GVHD * off any immunosuppressive agents for 30 days prior to collection (physiologic dose of cort…
Interventions
- BiologicalCD371-specific/YSNVz/I-18 CAR T cells
Cohorts will be infused with escalating doses of CD371-specific/YSNVz/IL-18 CAR T cells with lymphodepleting chemotherapy (LDC) to establish the maximum tolerated dose (MTD). There is a third, lower dose level (step-down dose) available for dose de-escalation in the event of severe toxicity at the first planned dose level.
Locations (7)
- Memorial Sloan Kettering at Basking Ridge (Limited Protocol Activities)Basking Ridge, New Jersey
- Memorial Sloan Kettering Monmouth (Limited protocol activities)Middletown, New Jersey
- Memorial Sloan Kettering Bergen (Limited Protocol Activities)Montvale, New Jersey
- Memorial Sloan Kettering Cancer Center @ Suffolk-Commack (Limited protocol activities)Commack, New York
- Memorial Sloan Kettering Westchester (Limited Protocol Activities)Harrison, New York
- Memorial Sloan Kettering Cancer Center (All protocol activites)New York, New York