NCT06441084Not yet recruitingPhase 1
A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation
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
Source: ClinicalTrials.gov · Last updated 4 Jun 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 15 (estimated)
- First submitted
- 27 May 2024
- Start date
- 30 Jun 2024
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Diseases
- Acute myeloid leukemia
- NCT number
- NCT06441084
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 15
- From 30 Jun 2024 to the primary completion date, 31 Dec 2028
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Received organ transplantation or planned transplantation；
- Received other treatment drugs after transplantation；
Other illness
- Have malignant tumors within 5 years before screening;
- Subjects with severe respiratory diseases;
- Subjects with clear history of neurological or psychiatric disorders in the past;
- 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;
- Graft-Versus-Host Disease (GVHD)\>II grades;
- Subjects with active nervous system autoimmune or inflammatory diseases;
- 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;
Other
- Bone marrow examination shows hematological recurrence;
- Subjects with acute promyelocytic leukemia(APL);
- Active central nervous system involvement；
- Expected survival period within 3 months;
- Subjects whose state is not suitable for entering the study;
- Other situations determined by investigator that it is not suitable to enter the study.
Who the study is looking for
- 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;
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.