Researchers plan to enroll a total of 100 patients with relapsed, refractory acute myeloid leukemia (AML) to receive a single dose of autologous CAR T cells.The safety of CAR T therapy was evaluated by observing adverse events after cell therapy;The efficacy of CAR-T therapy was evaluated against the outcome of patients' own past standard treatment regimens or historical data.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the pharmacokinetics (PK) of CAR T cells.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
In this study, patients with acute myeloid leukemia were treated with autologous anti-CLL1 CAR T cells by a single, intravenous infusion.Blood and bone marrow were collected before and 12 months after infusion to detect the number and activity of CAR T cells, and to evaluate the efficacy of CAR T cells.
No.212 Daguan Road, Xishan District
Kunming, Yunnan, China
RECRUITINGIncidence of AE after CAR-T infusion
Incidence of adverse events after CAR-T infusion Data. The records of adverse events (AE) should include: description of AE and all related symptoms, occurrence time, severity, duration, measures taken, final results and outcomes. According to NCI CTC AE 5.0 standard, AE was scored Grade. Safety evaluation indexes include but are not limited to the following contents 1. Any spontaneously reported and all directly observed adverse events; 2. Any abnormal changes in vital signs and physical examination; 3. The abnormal results of laboratory examination, physical examination and blood examination with clinical significance after treatment
Time frame: up to 12 months after CAR-T infusion
ORR rate
Overall response rate (ORR=CR+CRi) after CAR-T infusion
Time frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
PFS
Progression free survival (PFS) after CAR-T infusion
Time frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
OS
overall survival (OS) after CAR-T infusion
Time frame: 1month, 2 months, 3months, 6months ,12months after CAR-T infusion
Change of CAR Copies
CAR Copies measured by qPCR after CAR-T infusion
Time frame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
Change of CAR-T cell counts
CAR-T cell counts measured by Flow cytometry after CAR-T infusion
Time frame: Days 4, 7, 10, 14 and months 2, 3, 6, 9, 12 after Fast Dual CAR-T infusion
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