Acute Myeloid LeukemiaPhase 1NCT06441084
A Trial to Evaluate the Safety and Efficacy of NCR300 in Preventing Recurrence of Acute Myeloid Leukemia（AML) After Transplantation
A Phase 1 study testing NCR300 injection in people with Acute Myeloid Leukemia, run by Nuwacell Biotechnologies Co., Ltd..
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- NCR300 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 31 Dec 2031
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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；
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- 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;
Who cannot join
- 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；
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- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
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.
Read the detailed description
This is an open-label, dose-escalation and dose-expansion study to evaluate the safety, tolerability and preliminary efficacy of NCR300 injection.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- NCR300 injection
- Keywords
- iNK
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCR300 injectionBiological
Subjects will receive at least 1 cycle of NCR300 injection.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: NCR300 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity(DLT)
Number of participants with Dose-limiting toxicity in 28 days after first infusion
Measured: 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
Measured: From the date of initial infusion to a year after initial infusion
Secondary outcomes (4)
Maximum plasma concentration(Cmax)
Maximum plasma concentration of NCR300 in peripheral blood
Measured: 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 after doing at which maximun plasma concentration of NCR300 in peripheral blood is reached
Measured: 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)
The proportion of patients with hematological recurrence within 6 months after initial infusion to all patients
Measured: 6 Months After Initial Infusion
Minimal Residual Disease(MRD)
Changes in MRD before and after treatment
Measured: From the date of screening to a year after initial infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Responsible party
- Sponsor
- Investigators
- Zhao Wang, Doctor, Principal investigator, Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06441084
- Sponsor's protocol ID
- NCR300-2002
- Status last verified
- May 2024
- First submitted
- 27 May 2024
- Last updated
- 4 Jun 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06441084
- Acronym / sponsor ID
- NCR300-2002
- Conditions
- Acute Myeloid Leukemia
- Keywords
- iNK
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Friendship Hospital
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2031 (estimated)
- First posted
- 4 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NCR300 injection | Experimental | Biological: NCR300 injectionCohort1: Low dose NCR300 injection; Cohort2: Mid-low dose NCR300 injection; Cohort3: Mid-high dose NCR300 injection; Cohort4: High dose NCR300 injection. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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；
Key exclusion criteria (19 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NCR300 injectionSubjects will receive at least 1 cycle of NCR300 injection. | Biological | NCR300 injection |
Primary outcome
Dose-Limiting Toxicity(DLT)
Time frame: 4 weeks after initial infusion
Number of participants with Dose-limiting toxicity in 28 days after first infusion
Adverse Event(AE) or Serious Adverse Event(SAE)
Time frame: From the date of initial infusion to a year after initial infusion
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhao Wang, Doctor principal investigator
Capital Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NCR300 injection in people with Acute Myeloid Leukemia, run by Nuwacell Biotechnologies Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 4 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaowen Gong (15221195602, xwgong@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity(DLT) (time frame: 4 weeks after initial infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2024.