A Clinical Study to Investigate the Safety and Efficacy of CT0890B 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 CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12\~27 participants in this trial.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
27
Conditioning regimen: Days -9 to -3: Venetoclax administered with a target dose of 200 mg/day. Days -5 to -4: Cytarabine administered at 500 mg/m²/day. Days -5 to -3: Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day. Day 0: Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design: 1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells
Peking University People's Hospital
Beijing, China
RECRUITINGAdverse Events (AE) after CT0890B infusion
An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
Time frame: 12 months after CT890B infusion
Dose-limiting toxicity (DLT)
The DLT is evaluated as the proportion of patients who experienced adverse events related to CT0890B 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 CT0890B infusion
Time frame: Up to 28 days after CAR-T cells infusion
Composite response (CRc)
The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).
Time frame: 12 months after CT0890B infusion
Partial response (PR)
Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.
Time frame: 12 months after CT0890B infusion
Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy
This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 12 months after CT0890B infusion
Duration of response (DOR)
Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set. DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.
Time frame: 12 months after CT0890B infusion
Event-free survival (EFS)
EFS was defined as the time from the date of CAR-T infusion to the earliest occurrence of treatment failure, relapse, or death from any cause. Treatment failure was defined as failure to achieve CR, CRh, CRi, MLFS, or PR at both prespecified efficacy assessments. Relapse included hematologic or extramedullary relapse after achieving CR, CRh, CRi or MLFS. For patients with treatment failure (ineffective therapy), the primary EFS analysis assigned an event time of 1 day (i.e., the time from infusion to treatment receipt). Sensitivity analyses were performed using alternative definitions of event timing, including the actual date of treatment failure, the end of treatment, or the initiation of subsequent anti-leukemia therapy.
Time frame: 12 months after CT0890B infusion
Overall survival (OS)
OS is defined as the time from the date of receiving the infusion to the date of death from any cause.
Time frame: 12 months after CT0890B infusion
Minimal Residual Disease (MRD) Negativity Rate
MRD negativity rate was assessed in participants who achieved CR, CRh, CRi or MLFS. MRD negativity was defined as \<0.01% abnormal cells among CD45-positive cells as determined by multiparameter flow cytometry (MFC).
Time frame: 12 months after CT0890B infusion
Pharmacokinetic Endpoint - Peak expansion (Cmax)
The maximum concentration or peak value of CT0890B cells in plasma after infusion, measured by CAR copy number.
Time frame: 12 months after CT0890B infusion
Time to peak expansion (Tmax) of CT0890B
The time required to reach the peak expansion (maximum CAR copy number) in plasma following the infusion of CT0890B cells.
Time frame: 12 months after CT0890B infusion
Area under the curve (AUC) of CT0890B
The total cellular exposure in plasma after infusion, calculated based on the area under the CAR copy number-time curve.
Time frame: 12 months after CT0890B infusion
In vivo persistence of CT0890B
The duration for which CT0890B cells remain detectable in the plasma after infusion, monitored via CAR copy number.
Time frame: Up to 12 months after CT0890B infusion