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

NCT07441980 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2025144
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Relapsed/Refractory Acute Myeloid Leukemia(AML)

Keywords

CT1390B

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (11)

• Complete response (CR), complete response with partial hematologic recovery (CRh)，and complete response with incomplete hematologic recovery (CRi)

  12 months after CT1390B infusion

• Morphologic leukemia-free status (MLFS) and partial response (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)

  12 months after CT1390B infusion

• Event-free survival (EFS)

  12 months after CT1390B infusion

Study Arms (1)

CT1390B CAR-T cells Injection

EXPERIMENTAL

CAR-T cells#chimeric antigen receptor T cells#CT1390B cells infusion

Drug: CAR-T cells chimeric antigen receptor T cells

Interventions

CAR-T cells chimeric antigen receptor T cells DRUG

CT1390B cells infusion

CT1390B CAR-T cells Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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:
• )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)

Sponsors & Collaborators

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

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, China

Location

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Central Study Contacts

Ying Wang, Dr

CONTACT

+86-22-23909278; wangying1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2026
• First Posted: March 2, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): June 30, 2028
• Last Updated: March 2, 2026

Record last verified: 2026-02

Locations

CN (1)