Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn about the safety and tolerability of 3 different doses of CD33-CAR-T cells (referred to throughout the consent as "T-cells") in patients who have CD33-positive acute myeloid leukemia (AML) that is relapsed (has come back) or refractory (has not responded to treatment). CD33-CAR-T is made by genetically modifying (changing) your T-cells (a type of white blood cell). T-cells are genetically changed to help target leukemia cells. This is an investigational study. CD33-CAR-T is not FDA approved or commercially available. It is currently being used for research purposes only. The study doctor can explain how the study drug is designed to work. Up to 39 participants will be enrolled in this study. All will take part at MD Anderson.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
11
After enrollment, steady state leukapheresis performed to collect apheresis material. The goal is to achieve a target total nucleated cell (TNC) yield of at least 5 x 10\^9 (expected range 5 x 10\^8 - 5 x 10\^10), for up to two days.
25 mg/m2 administered by vein on Days -5 to -3.
900 mg/m2 administered by vein on Day -3.
CD33-CAR-T cell infusion administered by vein on Day 0. First group of participants receive the lowest dose level. Each new group will receive a higher dose than the one before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of T-cells is found. Starting dose level is \> 1.5 x 105/kg but ≤ 4.5 x 105/kg.
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Recommended Phase II Dose (RP2D) of CD33-CAR-T Cells
RP2D defined as the highest dose level in which 6 patients have been treated with at most 1 instance of dose limiting toxicity (DLT). DLT is defined as a clinically significant adverse event or abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, or concomitant medications and occurring during the first course on study that meets any of the following criteria: * CTCAE grades non-reversible grade 3, or any grade 4-5 allergic reactions related to the study cell infusion. * CTCAE grades non-reversible grade 3, or any grade 4-5 autoimmune reactions related to the study cell infusion. * CTCAE grades non-reversible grade 3, or any grade 4-5 organ toxicity (cardiac, dermatologic, gastrointestinal, hepatic, pulmonary, renal/genitourinary, or neurologic) not pre-existing or due to the underlying malignancy and occurring within 28 days of study product infusion related to study cell infusion.
Time frame: 28 days after completion of the CD33-CAR-T infusion
Disease Response to CD33-CAR-T Cells
Response to treatment evaluated according to the World Health Organization (WHO) standardized response criteria for myelodysplastic syndromes. Disease response to CD33-CAR-T cells defined as Complete Remission (CR), Complete Remission without Platelet Recovery (CRp), Complete Remission without Neutrophil Recovery (CRn), Complete Remission with Incomplete Blood Count Recovery (CRi), Partial Remission (PR) or Non-responder (NR).
Time frame: On Day 7, at Weeks 2, 4, and 8, and at Months 3, 6, and 12 after CD33-CAR-T Cell infusion
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.