Testing CT0991 CAR-T Cells for Relapsed or Refractory Acute Myeloid Leukemia
Tests CT0991 CAR-T cell infusion in adults with returned or non-responding acute myeloid leukemia.
Plain-language title generated from the registry record
Registry title: A Clinical Study to Explore the Safety and Efficacy of CT0991 in Relapsed/ Refractory Acute Myeloid Leukemia
Key facts
- Where
- Wuhan, ChinaSee the site
- Phase
- Phase 1
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 18-75 whose acute myeloid leukemia (AML) has come back or did not respond to treatment, and whose leukemia cells carry the CD38 marker.
- Age
- 18-75 years (inclusive)
- Sex
- Men and women
- Disease stage
- Relapsed or refractory acute myeloid leukemia (AML), as defined in the Chinese Guidelines (Version 2023). ECOG score 0-2. Estimated survival over 12 weeks.
- Earlier treatment
- Cannot join if they had CAR-T therapy, any treatment targeting CD38, or a stem cell transplant within 12 weeks.
- Biomarker or test result
- Leukemia cells must be positive for CD38, with an expression rate of ≥80% (flow cytometry or immunohistochemistry).
Main reasons for not taking part
- Acute promyelocytic leukemia (APL), BCR-ABL positive leukemia, secondary AML (other than MDS), or central nervous system leukemia
- History of epilepsy or other central nervous system disease
- Active, serious GVHD or systemic corticosteroids for GVHD
- Active uncontrolled infection, or serious heart disease such as NYHA class III-IV heart failure
- Severe lung disease, or needing extra oxygen to keep saturation above 92%
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07233018, who can take part
Where in China
- Union Hospital, Tongji Medical College, Huazhong University of Science and TechnologyWuhan, ChinaContact: HENG MEI MD，Ph.D.No longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- MEI HENG
- Trial code
- NCT07233018
- Record updated
- 18 November 2025
- Original description
A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients with Relapsed/Refractory Acute Myeloid Leukemia.Read full original descriptionShow less
A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients With Relapsed/Refractory Acute Myeloid Leukemia.
A Clinical Study to Investigate the Safety and Efficacy of CT0991 in Patients with Relapsed/Refractory Acute Myeloid Leukemia.
Inclusion: Volunteer to participate in the clinical trial; Fully understand and are informed of this study and sign the informed consent form; Willing to follow and able to complete all trial procedures; Age 18-75 years (inclusive), male or female; Estimated survival > 12 weeks; Patients with relapsed or refractory AML as defined in the Chinese Guidelines for the Diagnosis and Treatment of Relapsed and Refractory Acute Myeloid Leukemia (Version 2023); Flow cytometry or immunohistochemical examination of bone marrow or peripheral blood samples showed positive expression of CD38 in tumor cells and the expression rate was ≥80%; 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; 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: 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 CD38; Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD; History of myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin; Participants with a history of epilepsy or other central nervous system disease; 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 uncontrolled arrhythmia of significant clinical significance (as judged by the investigator), such as ventricular arrhythmia; History of severe nonischemic ardiomyopathy; 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; The participant has any serious illness, laboratory abnormality, or psychiatric disorder that may impair the ability to receive or tolerate planned trial treatment; or the investigator judges that the participant's participation in the clinical trial is not in his/her best interest (e.g.,compromised health), or may hinder, limit, or confound protocol-specific Assessments; Participants were diagnosed with acute promyelocytic leukemia (APL),BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase),secondary AML (other than MDS), central nervous system leukemia.