A Clinical Study to Explore the Safety and Efficacy of CT1390B in Relapsed/ Refractory Acute Myeloid Leukemia

Official title

A Clinical Study to Investigate the Safety and Efficacy of CT1390B in Patients With Relapsed/Refractory Acute Myeloid Leukemia

Overview

A Clinical Study to Investigate the Safety and Efficacy of CT1390B in Patients with Relapsed/Refractory Acute Myeloid Leukemia

Detailed description

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

Interventions

• Drug CAR-T cells chimeric antigen receptor T cells
  CT1390B cells infusion

Primary outcome measures

• Adverse Events (AE) after CT1390B infusion [Time frame: 12 months after CT1390B infusion]
• Dose-limiting toxicity （DLT） [Time frame: Up to 28 days after CAR-T cells infusion]
• MTD and/or dose range [Time frame: Up to 28 days after CAR-T cells infusion]

Secondary outcome measures (11)

• Complete response (CR), complete response with partial hematologic recovery (CRh)，and complete response with incomplete hematologic recovery (CRi) [Time frame: 12 months after CT1390B infusion]
• Morphologic leukemia-free status (MLFS) and partial response (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) [Time frame: 12 months after CT1390B infusion]
• Event-free survival (EFS) [Time frame: 12 months after CT1390B infusion]
• Overall survival (OS) [Time frame: 12 months after CT1390B infusion]
• Minimal Residual Disease (MRD) Negative Rate [Time frame: 12 months after CT1390B infusion]
• Cmax [Time frame: 28 days after CT1390B infusion]
• Tmax [Time frame: 28 days after CT1390B infusion]
• AUC [Time frame: 28 days after CT1390B infusion]
• Tlast [Time frame: 28 days after CT1390B infusion]

Eligibility criteria

Inclusion criteria

• Age 18-70 years (inclusive), male or female
• Relapsed or refractory acute myeloid leukemia definitively diagnosed as CLL-1 positive according to the WHO 2022 classification
• Bone marrow blast percentage ≥5% by morphology
• Estimated survival > 12 weeks
• ECOG score 0-2
• Participants should meet the following test results (no ongoing supportive care)

• Left ventricular ejection fraction (LVEF) > 50%
• ALT≤ 2.5 × ULN, AST ≤ 2.5 × ULN, total bilirubin ≤ 2 × ULN; ALT≤ 5 × ULN, AST ≤ 5 × ULN, total bilirubin ≤ 3 × ULN, if the liver is involved
• Endogenous creatinine clearance ≥ 30 mL/min (creatinine clearance calculated using the Cockcroft-Gault formula)
• Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN

Exclusion criteria

• Participants were diagnosed with acute promyelocytic leukemia (APL) BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), active central nervous system leukemia
• Participants with a history of epilepsy or other central nervous system disease
• Participants who have previously received autologous or allogeneic CAR-T therapy
• Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
• Participants who have received prior immunotherapy targeting CLL-1
• Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD
• Participant has any of the following at screening:

1)Active, uncontrolled systemic infection or requiring intravenous anti-infective agents 2)Any of the following cardiac conditions, including:

• New York Heart Association Class III-IV heart failure;
• History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Lymphodepleting Chemotherapy;
• History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
• History of severe non-ischemic cardiomyopathy;
• Other cardiac disease that the investigator believe could jeopardize the participant 's well-being or compromise participation in this clinical trial; 3) Active bleeding of clinical significance as judged by the investigator 4)Requiring supplemental oxygen to maintain oxygen saturation> 92% 5)Patients with severe chronic obstructive pulmonary disease (COPD) or other lung diseases that cannot tolerate CAR-T treatment as judged by the investigator 8. Has HIV, syphilis infection, active hepatitis B virus infection (HBsAg positive and HBV-DNA above the detection limit), or active hepatitis C virus infection (HCV antibody and HCV-DNA positive)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• Institute of Hematology & Blood Diseases Hospital, China — Tianjin

Identifiers

NCT: NCT07441980 · IIT2025144

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗