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

23 mei 2026 bijgewerkt door: Xiangyu Zhao, Peking University People's Hospital

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

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

Studie Overzicht

Gedetailleerde beschrijving

This is a single-arm, open-label, dose-escalation clinical trial to evaluate the safety, efficacy, and cellular pharmacokinetics of CT0890B in patients with relapsed or refractory acute myeloid leukemia. It is planned to enroll 12~27 participants in this trial.

Studietype

Ingrijpend

Inschrijving (Geschat)

27

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Contact Back-up

Studie Locaties

      • Beijing, China, 100044
        • Werving
        • Peking University People's Hospital
        • Onderonderzoeker:
          • Meng Lv, M.D, Ph.D
        • Contact:
        • Hoofdonderzoeker:
          • Xiangyu Zhao, M.D, Ph.D

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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;

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: CAR-T cells chimeric antigen receptor T cells
CT0890B cells infusion

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

Andere namen:
  • Off-the-shelf allogeneic CAR-T cells

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Adverse Events (AE) after CT0890B infusion
Tijdsspanne: 12 months after CT890B 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)
Tijdsspanne: Up to 28 days after CAR-T cells infusion
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
Tijdsspanne: Up to 28 days after CAR-T cells infusion
Evaluate Dose limited toxicity and recommended dosage range after CT0890B infusion
Up to 28 days after CAR-T cells infusion

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Composite response (CRc)
Tijdsspanne: 12 months after CT0890B infusion
The composite response rate (CRc) included complete response (CR), complete response with partial hematologic recovery (CRh), complete response with incomplete hematologic recovery (CRi), and morphologic leukemia-free state (MLFS). Responses were assessed in accordance with the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet criteria for acute myeloid leukemia (AML).
12 months after CT0890B infusion
Partial response (PR)
Tijdsspanne: 12 months after CT0890B infusion
Partial response (PR) was defined and assessed according to the Technical Guidelines for Clinical Development of New Drugs for Acute Myeloid Leukemia and the 2022 European LeukemiaNet response criteria for AML.
12 months after CT0890B infusion
Rate of Subsequent Stem Cell Transplantation After CAR-T Therapy
Tijdsspanne: 12 months after CT0890B infusion
This secondary endpoint was defined as the proportion of patients who proceeded to stem cell transplantation after CAR-T therapy during the study period.
12 months after CT0890B infusion
Duration of response (DOR)
Tijdsspanne: 12 months after CT0890B infusion
Patients achieving CR, CRi, CRh, or MLFS were included in the duration of response (DOR) analysis set. DOR was defined as the time from the date of first documented response to the date of disease relapse or death from any cause, whichever occurred first.
12 months after CT0890B infusion
Event-free survival (EFS)
Tijdsspanne: 12 months after CT0890B infusion

EFS was defined as the time from the date of CAR-T infusion to the earliest occurrence of treatment failure, relapse, or death from any cause. Treatment failure was defined as failure to achieve CR, CRh, CRi, MLFS, or PR at both prespecified efficacy assessments. Relapse included hematologic or extramedullary relapse after achieving CR, CRh, CRi or MLFS.

For patients with treatment failure (ineffective therapy), the primary EFS analysis assigned an event time of 1 day (i.e., the time from infusion to treatment receipt). Sensitivity analyses were performed using alternative definitions of event timing, including the actual date of treatment failure, the end of treatment, or the initiation of subsequent anti-leukemia therapy.

12 months after CT0890B infusion
Overall survival (OS)
Tijdsspanne: 12 months after CT0890B infusion
OS is defined as the time from the date of receiving the infusion to the date of death from any cause.
12 months after CT0890B infusion
Minimal Residual Disease (MRD) Negativity Rate
Tijdsspanne: 12 months after CT0890B infusion
MRD negativity rate was assessed in participants who achieved CR, CRh, CRi or MLFS. MRD negativity was defined as <0.01% abnormal cells among CD45-positive cells as determined by multiparameter flow cytometry (MFC).
12 months after CT0890B infusion
Pharmacokinetic Endpoint - Peak expansion (Cmax)
Tijdsspanne: 12 months after CT0890B infusion
The maximum concentration or peak value of CT0890B cells in plasma after infusion, measured by CAR copy number.
12 months after CT0890B infusion
Time to peak expansion (Tmax) of CT0890B
Tijdsspanne: 12 months after CT0890B infusion
The time required to reach the peak expansion (maximum CAR copy number) in plasma following the infusion of CT0890B cells.
12 months after CT0890B infusion
Area under the curve (AUC) of CT0890B
Tijdsspanne: 12 months after CT0890B infusion
The total cellular exposure in plasma after infusion, calculated based on the area under the CAR copy number-time curve.
12 months after CT0890B infusion
In vivo persistence of CT0890B
Tijdsspanne: Up to 12 months after CT0890B infusion
The duration for which CT0890B cells remain detectable in the plasma after infusion, monitored via CAR copy number.
Up to 12 months after CT0890B infusion

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: XiangYu Zhao, M.D, Ph.D, Peking University People's Hospital

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

7 mei 2026

Primaire voltooiing (Geschat)

31 december 2027

Studie voltooiing (Geschat)

31 december 2029

Studieregistratiedata

Eerst ingediend

1 mei 2026

Eerst ingediend dat voldeed aan de QC-criteria

23 mei 2026

Eerst geplaatst (Werkelijk)

1 juni 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

1 juni 2026

Laatste update ingediend die voldeed aan QC-criteria

23 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Andere studie-ID-nummers

  • CT0890B-CG8001

Plan Individuele Deelnemersgegevens (IPD)

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Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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