Clinical trial · Interventional
Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML
A Phase I Study to Evaluate the Safety and Efficacy of Allogeneic CAR-T Cells (CT0890B) in Patients With NKG2DL-Positive Relapsed/Refractory Acute Myeloid Leukemia
NCT07617285CI-TRIAL-00113044recruitingPhase 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 CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| AML | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Refractory/Relapse Acute Myeloid Leukemia | — | UNRESOLVED | — |
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
- CAR-T cells chimeric antigen receptor T cells
- description
- CT0890B cells infusion
- interventionNames
- Drug: CAR-T cells chimeric antigen receptor T cells
Primary outcomes (3)
- measure
- Adverse Events (AE) after CT0890B infusion
- timeFrame
- 12 months after CT890B 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 CT0890B 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 (R/R AML) diagnosed according to the 2022 World Health Organization classification or ELN criteria, with confirmed NKG2D ligand-positive disease. 3. Bone marrow blasts ≥5% by morphology. 4. Estimated life expectancy \>12 weeks. 5. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2. 6. Adequate organ function without ongoing supportive care, defined as: 1. Cardiac: left ventricular ejection fraction (LVEF) ≥50%; 2. Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN; 3. Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); 4. Coagulation: activated partial thromboplastin time (APTT) ≤1.5 × ULN and prothrombin time (PT) ≤1.5 × ULN. c) Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula); d) Coagulation: 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), 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 NKG2DL; 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 Qinglin; 3. History of uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia; 4. History of severe nonischemic ardiomyopathy; 5. Other cardiac disease that the investigatorbelieve 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;
References
Publications (0)
Data not yet available
No reference posted for this study.