Allogeneic CAR-T CT0890B for relapsed/refractory AML

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a phase 1, open-label, dose-escalation trial evaluating CT0890B, an allogeneic CAR-T product, in patients with relapsed or refractory AML. The study will assess safety, preliminary efficacy, and cellular pharmacokinetics, enrolling roughly 12 to 27 participants. Eligibility requires adults 18–70 with NKG2D ligand‑positive AML, adequate organ function, and a reasonable life expectancy. The trial is conducted at Peking University People’s Hospital with collaboration from CARsgen Therapeutics, and uses a single-arm design to explore dose tolerability and early signals of activity.

Why it matters

Who can join: the full rules

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;

Where it's running

• Peking University People's Hospital
  Beijing, China Recruiting

Study contacts

• Principal investigator: XiangYu Zhao, M.D, Ph.D — Peking University People's Hospital
• Study coordinator: Xiangyu Zhao, M.D,Ph.D
• Email: Zhao_xy@bjmu.edu.cn
• Phone: 010-88325531

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.