Clinical trial · Interventional
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
NCT07441980CI-TRIAL-00104352not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
A Clinical Study to Investigate the Safety and Efficacy of CT1390B in Patients with Relapsed/Refractory Acute Myeloid Leukemia
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Relapsed/Refractory Acute Myeloid Leukemia(AML) | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| CAR-T cells chimeric antigen receptor T cells | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CT1390B CAR-T cells Injection
- description
- CAR-T cells#chimeric antigen receptor T cells#CT1390B cells infusion
- interventionNames
- Drug: CAR-T cells chimeric antigen receptor T cells
Primary outcomes (3)
- measure
- Adverse Events (AE) after CT1390B infusion
- timeFrame
- 12 months after CT1390B infusion
- description
- An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria
- measure
- Dose-limiting toxicity (DLT)
- timeFrame
- Up to 28 days after CAR-T cells infusion
- description
- 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
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.