NCT07617285 Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML
| NCT ID | NCT07617285 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Peking University People's Hospital |
| Condition | AML |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2026-05-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2026-05-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.
Eligibility Criteria
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;
Contact & Investigator
XiangYu Zhao, M.D, Ph.D
PRINCIPAL INVESTIGATOR
Peking University People's Hospital
Frequently Asked Questions
Who can join the NCT07617285 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying AML. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07617285 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07617285 currently recruiting?
Yes, NCT07617285 is actively recruiting participants. Contact the research team at Zhao_xy@bjmu.edu.cn for enrollment information.
Where is the NCT07617285 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07617285 clinical trial?
NCT07617285 is sponsored by Peking University People's Hospital. The principal investigator is XiangYu Zhao, M.D, Ph.D at Peking University People's Hospital. The trial plans to enroll 27 participants.