Allogeneic CAR-T(CT0890B) in NKG2DL+ R/R AML

NCT07617285 | Recruiting Phase 1 DMC

• 1 other identifier: CT0890B-CG8001
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 1

Brief Summary

A Clinical Study to Investigate the Safety and Efficacy of CT0890B in Patients with Relapsed/Refractory Acute Myeloid Leukemia.

Conditions

AML; Refractory/Relapse Acute Myeloid Leukemia

Keywords

CT0890B; Universal CAR-T; AML

Outcome Measures

Primary Outcomes (3)

• Adverse Events (AE) after CT0890B infusion

  An assessment of severity grade will be made according to the National Cancer Institute Common Terminology Criteria

  12 months after CT890B infusion

• Dose-limiting toxicity (DLT)

  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

  Up to 28 days after CAR-T cells infusion

• MTD and/or dose range

  Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion

  Up to 28 days after CAR-T cells infusion

Secondary Outcomes (11)

• Composite response (CRc)

  12 months after CT0890B infusion

• Partial response (PR)

  12 months after CT0890B infusion

• Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy

  12 months after CT0890B infusion

• Duration of response (DOR)

  12 months after CT0890B infusion

• Event-free survival (EFS)

  12 months after CT0890B infusion

Study Arms (1)

CAR-T cells chimeric antigen receptor T cells

EXPERIMENTAL

CT0890B cells infusion

Drug: CAR-T cells chimeric antigen receptor T cells

Interventions

CAR-T cells chimeric antigen receptor T cells DRUG

Conditioning regimen: Days -9 to -3: Venetoclax administered with a target dose of 200 mg/day. Days -5 to -4: Cytarabine administered at 500 mg/m²/day. Days -5 to -3: Cyclophosphamide at 300 mg/m²/day plus Fludarabine at 30 mg/m²/day. Day 0: Infusion of CT0890B CAR-T cells at one of four dose levels using an i3+3 Dose-Escalation Design: 1.5 × 10⁸ total cells, 3.0 × 10⁸ total cells, 4.5 × 10⁸ total cells, 6.0 × 10⁸ total cells

Also known as: Off-the-shelf allogeneic CAR-T cells

CAR-T cells chimeric antigen receptor T cells

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18-70 years (inclusive), male or female.
• 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.
• Bone marrow blasts ≥5% by morphology.
• Estimated life expectancy \>12 weeks.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
• Adequate organ function without ongoing supportive care, defined as:
• Cardiac: left ventricular ejection fraction (LVEF) ≥50%;
• Hepatic: ALT and AST ≤2.5 × upper limit of normal (ULN), and total bilirubin ≤2 × ULN;
• Renal: creatinine clearance ≥30 mL/min (calculated using the Cockcroft-Gault formula);
• 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.

You may not qualify if:

• Participants were diagnosed with acute promyelocytic leukemia (APL), BCR-ABL positive leukemia (chronic myeloid leukemia in acute phase), central nervous system leukemia;
• Participants with a history of epilepsy or other central nervous system disease;
• 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 NKG2DL;
• Participant has clinically significant active GVHD or is receiving systemic corticosteroids for GVHD;
• Participant has any of the following at screening:
• )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 myocardial infarction, coronary artery bypass grafting, or unstable angina within 6 months prior to Qinglin;
• 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;

Sponsors & Collaborators

• Peking University People's Hospital: lead
• CARsgen Therapeutics Co., Ltd.: collaborator

Study Sites (1)

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

Study Officials

• XiangYu Zhao, M.D, Ph.D

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiangyu Zhao, M.D,Ph.D

CONTACT

010-88325531; Zhao_xy@bjmu.edu.cn

Meng Lv, M.D., Ph.D

CONTACT

010-88316617; drlvmeng@bjmu.edu.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Single Group Assignment of CAR-T

Study Record Dates

• First Submitted: May 1, 2026
• First Posted: June 1, 2026
• Study Start: May 7, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2029
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

CN (1)