A Clinical Study to Investigate the Safety and Efficacy of CT1390B in Patients with Relapsed/Refractory Acute Myeloid Leukemia
This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT1390B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 9\~18 participants in this trial
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
CT1390B cells infusion
Institute of Hematology & Blood Diseases Hospital, China
Tianjin, China
Adverse Events (AE) after CT1390B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT1390B infusion
Dose-limiting toxicity (DLT)
The DLT is evaluated as the proportion of patients who experienced adverse events related to CT1390B that meet the criteria for DLT events after the first infusion
Time frame: Up to 28 days after CAR-T cells infusion
MTD and/or dose range
Evaluate Dose limited toxicity and recommended dosage range after CT1390B infusion
Time frame: Up to 28 days after CAR-T cells infusion
Complete response (CR), complete response with partial hematologic recovery (CRh),and complete response with incomplete hematologic recovery (CRi)
Performed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and ELN 2022 Criteria for AML defined as achieving CR,CRh and CRi
Time frame: 12 months after CT1390B infusion
Morphologic leukemia-free status (MLFS) and partial response (PR).
Performed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and ELN 2022 Criteria for AML defined of Achieve MLFS and PR
Time frame: 12 months after CT1390B infusion
Proportion of patients undergoing stem cell transplantation following CAR-T therapy.
Time frame: 12 months after CT1390B infusion
Duration of response (DOR)
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Participants achieving CR/CRi/CRh will be included in the analysis set for DOR. DOR is defined as the time from the date of confirmed response until the date of disease relapse or death from any cause, whichever occurs first
Time frame: 12 months after CT1390B infusion
Event-free survival (EFS)
Defined as the time from the date of receiving the infusion to the date of treatment failure (failure to achieve CR/CRh/CRi/MLFS/PR after both efficacy assessments), or relapse (hematologic relapse or extramedullary relapse after CR/CRh/CRi), or death from any cause, whichever occurs first. When an EFS event was "Ineffective Therapy", the primary analysis of EFS was performed on a 1-day basis (ie, time to treatment received as the event). For a more comprehensive assessment, sensitivity analyses could be performed using the actual date of treatment failure, end of treatment, or start of next-line anti-leukemia therapy as the end of EFS for treatment failure, respectively
Time frame: 12 months after CT1390B infusion
Overall survival (OS)
Defined as the time from the date of receiving the infusion to the date of death from any cause
Time frame: 12 months after CT1390B infusion
Minimal Residual Disease (MRD) Negative Rate
tested in all participants who achieved CR/CRh/CRi. MRD negativity was defined as abnormal cells detected by the MFC method accounting for \< 0.1% of CD45-positive cells
Time frame: 12 months after CT1390B infusion
Cmax
the peak of CARgene copy number in peripheral blood
Time frame: 28 days after CT1390B infusion
Tmax
time to reach the peak of CARgene copy number in peripheral blood
Time frame: 28 days after CT1390B infusion
AUC
area under curve of CARgene copy number in peripheral blood
Time frame: 28 days after CT1390B infusion
Tlast
duration of existence of CARgene copy number in peripheral blood
Time frame: 28 days after CT1390B infusion