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Not yet recruiting NCT06441084

A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation

Phase I Interventional Acute Myeloid Leukemia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: NCR300 injection.
Who it may be relevant to
Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Phase I or II Clinical Trial Evaluating the Safety and Efficacy of NCR300 Injection in Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation

Overview

A Trial to Evaluate the Safety and Efficacy of iNK in the Treatment of Subjects for Preventing Recurrence of Acute Myeloid Leukemia After Allogeneic Blood Stem Cell Transplantation.

Detailed description

This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.

Interventions

  • Biological NCR300 injection
    Subjects will receive at least 1 cycle of NCR300 injection.

Primary outcome measures

  • Dose-Limiting Toxicity(DLT) [Time frame: 4 weeks after initial infusion]
  • Adverse Event(AE) or Serious Adverse Event(SAE) [Time frame: From the date of initial infusion to a year after initial infusion]
Secondary outcome measures (4)
  • Maximum plasma concentration(Cmax) [Time frame: 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.]
  • Time after doing at which maximun plasma concentration is reached(Tmax) [Time frame: 2 hours before initial infusion;4 hours ,24 hous, 3 Days after initial infusion.2 hours before second infusion; 24 hous, 3 Days after second infusion.]
  • Cumulative Incidence of Relapse(CIR) [Time frame: 6 Months After Initial Infusion]
  • Minimal Residual Disease(MRD) [Time frame: From the date of screening to a year after initial infusion]

Eligibility criteria

Inclusion criteria

1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF);

2.18-65years;

3.Clinical diagnosis of AML;

4.Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;

5.Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；

6.Have already recovered from the adverse reactions of previous treatment；

7.Having appropriate organ functions；

8.Eastern Cooperative Oncology Group(ECOG)<3;

9.Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;

Exclusion criteria

  • Bone marrow examination shows hematological recurrence;
  • Have malignant tumors within 5 years before screening;
  • Subjects with acute promyelocytic leukemia(APL);
  • Subjects with severe respiratory diseases;
  • Subjects with clear history of neurological or psychiatric disorders in the past;
  • Active central nervous system involvement；
  • HIV(human immunodeficiency virus) antibody positive,treponema pallidum(TP) antibody positive.Have active hepatitis B or hepatitis C;
  • Allergies to NCR300 or its excipients;
  • Subjects with active cardiovascular and cerebrovascular diseases;
  • Received organ transplantation or planned transplantation；
  • Received other treatment drugs after transplantation；
  • Graft-Versus-Host Disease (GVHD)>II grades;
  • Subjects with active nervous system autoimmune or inflammatory diseases;
  • Expected survival period within 3 months;
  • Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances;
  • Having mental illness；
  • Having uncontrollable active infections;
  • Subjects whose state is not suitable for entering the study;
  • Other situations determined by investigator that it is not suitable to enter the study.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Prevention

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06441084 · NCR300-2002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗