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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Relapsed/Refractory Acute Myeloid Leukemia(AML)
• Intervention / Treatment: Drug: CAR-T cells chimeric antigen receptor T cells

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

• Study Type: Interventional
• Enrollment (Estimated): 18
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Ying Wang, Dr; Phone Number: +86-22-23909278; Email: wangying1@ihcams.ac.cn

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Age 18-70 years (inclusive), male or female
2. Relapsed or refractory acute myeloid leukemia definitively diagnosed as CLL-1 positive according to the WHO 2022 classification
3. Bone marrow blast percentage ≥5% by morphology
4. Estimated survival > 12 weeks
5. ECOG score 0-2

6. Participants should meet the following test results (no ongoing supportive care)

   1. Left ventricular ejection fraction (LVEF) > 50%
   2. 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
   3. Endogenous creatinine clearance ≥ 30 mL/min (creatinine clearance calculated using the Cockcroft-Gault formula)
   4. Activated partial thromboplastin time (APTT) ≤ 1.5 × ULN and prothrombin time (PT) ≤ 1.5 × ULN

Exclusion Criteria:

1. Participants were diagnosed with acute promyelocytic leukemia (APL) BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), active central nervous system leukemia
2. Participants with a history of epilepsy or other central nervous system disease
3. Participants who have previously received autologous or allogeneic CAR-T therapy
4. Participants who have received autologous stem cell transplantation or allogeneic stem cell transplantation within 12 weeks
5. Participants who have received prior immunotherapy targeting CLL-1
6. Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD
7. 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:

1. New York Heart Association Class III-IV heart failure;
2. History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Lymphodepleting Chemotherapy;
3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia;
4. History of severe non-ischemic cardiomyopathy;
5. 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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CT1390B CAR-T cells Injection; CAR-T cells#chimeric antigen receptor T cells#CT1390B cells infusion	Drug: CAR-T cells chimeric antigen receptor T cells; CT1390B cells infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (AE) after CT1390B infusion	An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria	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	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	Up to 28 days after CAR-T cells infusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	12 months after CT1390B infusion
Proportion of patients undergoing stem cell transplantation following CAR-T therapy.		12 months after CT1390B infusion
Duration of response (DOR)	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	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	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	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	12 months after CT1390B infusion
Cmax	the peak of CARgene copy number in peripheral blood	28 days after CT1390B infusion
Tmax	time to reach the peak of CARgene copy number in peripheral blood	28 days after CT1390B infusion
AUC	area under curve of CARgene copy number in peripheral blood	28 days after CT1390B infusion
Tlast	duration of existence of CARgene copy number in peripheral blood	28 days after CT1390B infusion

Collaborators and Investigators

• Sponsor: Institute of Hematology & Blood Diseases Hospital, China

Study record dates

Study Major Dates

• Study Start (Estimated): March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028

Study Registration Dates

• First Submitted: January 22, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 2, 2026

Study Record Updates

• Last Update Posted (Actual): March 2, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: CT1390B
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: IIT2025144

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No