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

NCT06441084 | Not Yet Recruiting Phase 1

• 1 other identifier: NCR300-2002
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Acute Myeloid Leukemia

Keywords

iNK

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity(DLT)

  Number of participants with Dose-limiting toxicity in 28 days after first infusion

  4 weeks after initial infusion

• Adverse Event(AE) or Serious Adverse Event(SAE)

  Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0

  From the date of initial infusion to a year after initial infusion

Secondary Outcomes (4)

• Maximum plasma concentration(Cmax)

  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)

  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)

  6 Months After Initial Infusion

• Minimal Residual Disease(MRD)

  From the date of screening to a year after initial infusion

Study Arms (1)

NCR300 injection

EXPERIMENTAL

Cohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection.

Biological: NCR300 injection

Interventions

NCR300 injection BIOLOGICAL

Subjects will receive at least 1 cycle of NCR300 injection.

NCR300 injection

Eligibility Criteria

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

You may qualify if:

• Subjects who understand and voluntarily sign the Informed Consent Form(ICF);
• years;
• Clinical diagnosis of AML;
• Accepted allogeneic blood stem cell transplantation within 60 to 28 days prior before initial infusion;
• Complete donor chimerism and with high-risk recurrence factors prior to transplantation , or bone marrow examination shows positive MRD；
• Have already recovered from the adverse reactions of previous treatment；
• Having appropriate organ functions；
• Eastern Cooperative Oncology Group(ECOG)\<3;
• Subjects who are able to comply with contraceptives from the study period to 6 months after the end of this study;

You may not qualify if:

• 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;

Sponsors & Collaborators

• Nuwacell Biotechnologies Co., Ltd.: lead
• Beijing Friendship Hospital: collaborator

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Zhao Wang, Doctor

  Capital Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xiaowen Gong

CONTACT

15221195602; xwgong@nuwacell.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2024
• First Posted: June 4, 2024
• Study Start: June 30, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2031
• Last Updated: June 4, 2024

Record last verified: 2024-05