Acute Myeloid Leukemia (AML)Early Phase 1iNK-r/r AMLNCT06702098
Induced Pluripotent Stem Cells Derived Natural Killer Cells Therapy for Refractory and Relaps Acute Myelogenous Leukemia
A Early Phase 1 study testing iNK cells in people with Acute Myeloid Leukemia (AML), run by Guangzhou Ruixin Biotechnological Co., LTD at 1 site in China.
Trial summary
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Myeloid Leukemia (AML)
- What is being tested?
- iNK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 25 Nov 2024to 24 Nov 2026
- Phase
- Early 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients must satisfy the following criteria to be enrolled in the study.
- Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF).
- Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted.
- Patient has eligible disease status:
- 3.1 Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017).
- 3.2 R/R diagnosis based on confirmed diagnosis with local pathology report following any reinduction/ salvage therapy ELN guidelines.
Show all 13Show fewer
- 3.2.1 Relapsed AML are defined as having relapsed after achieving ≥ 1 CR, including relapse after allogeneic stem cell transplantation (≥ 2 months after transplant).
- 3.2.2 Refractory AML, defined as not achieving CR, CRi, or MLFS after 2 or more cycles of induction therapy (primary refractory) or not achieving CR after treatment for relapsed AML.
- 3.2.3 Secondary AML (MDS transformation): Secondary AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML.
- 3.2.4 Treatment-related AML: Treatment-related AML patients are eligible to participate if they have received a minimum of one prior line of treatment for AML.
- No active infection.
- No heart , liver and kidney functioninsufficiency.
- No central nervous system leukemia.
Who cannot join
- Subject meets one of the following criteria. 1.1History of CAR-T treatment with third degree CRS. 1.2 History of NK cell and CIK cell immunotherapy.
- Serious cardiovascular and cerebrovascular diseases. 2.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms.
- 2.2 Complete left bundle branch block, second- or third-degree atrioventricular block; 2.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 2.4 New York Heart Association (NYHA) class II or above congestive heart failure.
- 2.5 Left ventricular ejection fraction (LVEF) <50% in color Doppler echocardiography.
- 2.6 History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
- Previous or present concomitant other malignancies (except for basal cell carcinoma of the skin, non-melanoma and non-melanoma, carcinoma in situ of the breast/cervix that have been effectively controlled, and other malignancies that have been effectively controlled without treatment in the past five years).
Show all 11Show fewer
- Uncontrollable systemic disease(e.g. uncontrolled hypertension, diabetes, etc).
- Pregnant women, lactating females, patients who refuse to use effective contraception during the study.
- history of severe neurological or psychiatric illness.
- Positive for hepatitis B surface antigen.
- Patients who are judged by the investigator to be unsuitable for participating in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Guangzhou Ruixin Biotechnology Co., Ltd
Guangzhou, Guangdong Province, China, 523786
Luo Yun Luo, Medical Department Manager, +86-0769-26621834, gzrxsw001@163.com
About this study
Official title: Single-center and Single-arm Clinical Study of INK Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.
Read the detailed description
Natural killer (NK) cells are lymphocytes of the innate immune system and could recognize and kill a wide range of cells in distress, particularly tumour cells and cells infected with viruses. Induced pluripotent setm cells(iPSCs) derived NK cells have better proliferative capacity and homogeneity than donor peripheral blood or umbilical cord blood derived NK cells. We conduct this clinical study to evaluate the efficacy and safety of INK cells in the treatment of acute myeloid leukemia and our purpose is to find new treatment option.
- Conditions
- Acute Myeloid Leukemia (AML)
- Being tested
- iNK cells
- Keywords
- iNK cells, R/R AML, iPSCs
- 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.
iNK cellsDrug
Induced pluripotent stem cells derived NK cells.
| Study group | Role | What they receive |
|---|---|---|
| Cell therapy group | Experimental | Intravenous infusion of iNK cells is given to the subject, 5*108 to 1*109 cells/dose, two doses per week, a total of 8 doses. And then 1*109 cells/dose, one doses every 4 weeks , a total of 5 doses. Receives: Drug: iNK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events
Measured: 12 months
MRD negative rate
Measured: 12 months
Progression-free Survival
Measured: 12 months
Overall survival
Measured: 12 months
Secondary outcomes (1)
Determination of chimerism of iNK cells in peripheral blood of subject.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2024
- Study start25 Nov 2024 (estimated)
- Primary completion31 Aug 2026 (estimated)
- Study completion24 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid Leukemia (AML)Studies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangzhou Ruixin Biotechnological Co., LTD
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Responsible party
- Sponsor
- Investigators
- Huo Tan, MD, Principal investigator, Fifth Affiliated Hospital of Guangzhou Medical UniversityRunhui Zheng, MD, Study director, Fifth Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06702098
- Sponsor's protocol ID
- Ruixin Biotech
- Acronym
- iNK-r/r AML
- Status last verified
- Nov 2024
- First submitted
- 17 Nov 2024
- Last updated
- 22 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidenti- fication (text, tables, figures, and appendices). What other documents will be available？ Study Protocol. When will data be available (start and end dates)? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee(learned intermediary) identified for this purpose. For what types of analyses? For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in clinical research center of the fifth affiliated hospital of Guangzhou medical university (https://www.gyfwyy.com/gcp/).
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-center and Single-arm Clinical Study of INK Cell Therapy for Relapsed and Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT06702098
- Acronym / sponsor ID
- iNK-r/r AML / Ruixin Biotech
- Conditions
- Acute Myeloid Leukemia (AML)
- Keywords
- iNK cells, R/R AML, iPSCs
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Guangzhou Ruixin Biotechnological Co., LTDIndustry (pharma, biotech, devices)
- Collaborators
- Fifth Affiliated Hospital of Guangzhou Medical University
- Study start
- 25 Nov 2024 (estimated)
- Primary completion
- 31 Aug 2026 (estimated)
- Study completion
- 24 Nov 2026 (estimated)
- First posted
- 22 Nov 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.
This is a clinical study on the use of iNK cells for the treatment of refractory relapsed acute myeloid leukemia.
Detailed description
Natural killer (NK) cells are lymphocytes of the innate immune system and could recognize and kill a wide range of cells in distress, particularly tumour cells and cells infected with viruses. Induced pluripotent setm cells(iPSCs) derived NK cells have better proliferative capacity and homogeneity than donor peripheral blood or umbilical cord blood derived NK cells. We conduct this clinical study to evaluate the efficacy and safety of INK cells in the treatment of acute myeloid leukemia and our purpose is to find new treatment option.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cell therapy group | Experimental | Drug: iNK cellsIntravenous infusion of iNK cells is given to the subject, 5*108 to 1*109 cells/dose, two doses per week, a total of 8 doses. And then 1*109 cells/dose, one doses every 4 weeks , a total of 5 doses. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Patients must satisfy the following criteria to be enrolled in the study.
- Patient is ≥ 18 and ≤ 80 years of age at the time of signing the Study informed consent form (ICF).
- Patient understands and voluntarily signs the Study ICF prior to any study-related assessments/procedures are conducted.
- Patient has eligible disease status:
- 3.1 Primary or Secondary acute myeloid leukemia (AML) Patients in first of second Morphological Complete Remission (CR), Morphological Complete Remission with incomplete hematologic recovery (CRi), or Morphologic Leukemia-free State (MLFS) as defined by the European LeukemiaNet (ELN) recommendations for AML Response Criteria (Dohner, 2017).
Key exclusion criteria (11 listed)
- Subject meets one of the following criteria. 1.1History of CAR-T treatment with third degree CRS. 1.2 History of NK cell and CIK cell immunotherapy.
- Serious cardiovascular and cerebrovascular diseases. 2.1 Severe heart rhythm or conduction abnormalities, corrected QT interval (QTc)≥480 ms.
- 2.2 Complete left bundle branch block, second- or third-degree atrioventricular block; 2.3 Severe, uncontrolled cardiac arrhythmias requiring medication. 2.4 New York Heart Association (NYHA) class II or above congestive heart failure.
- 2.5 Left ventricular ejection fraction (LVEF) <50% in color Doppler echocardiography.
- 2.6 History of myocardial infarction, unstable angina, severe unstable ventricular arrhythmia or any other arrhythmia requiring treatment, severe pericardial disease, ECG evidence of acute ischemic or active conduction system abnormalities within 6 months prior to recruitment.
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 |
|---|---|---|
| iNK cellsInduced pluripotent stem cells derived NK cells. | Drug | Cell therapy group |
Primary outcome
Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
MRD negative rate
Time frame: 12 months
Progression-free Survival
Time frame: 12 months
Overall survival
Time frame: 12 months
1 secondary outcome
Determination of chimerism of iNK cells in peripheral blood of subject.
Time frame: 12 months
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 22 Nov 2024.
- Individual participant dataSharing planned: Yes. What data in particular will be shared? Individual participant data that underlie the results reported in this article, after deidenti- fication (text, tables, figures, and appendices). What other documents will be available？ Study Protocol. When will data be available (start and end dates)? Beginning 9 months and ending 36 months following article publication. With whom? Investigators whose proposed use of the data has been approved by an independent review committee(learned intermediary) identified for this purpose. For what types of analyses? For individual participant data meta-analysis. By what mechanism will data be made available? Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in clinical research center of the fifth affiliated hospital of Guangzhou medical university (https://www.gyfwyy.com/gcp/).
Related trials for Acute Myeloid Leukemia (AML)
RecruitingPhase 1
A Study of CHM-029 in Participants With NPM1 Mutated, KMT2A or NUP98 Rearranged AML
AML (Acute Myeloid Leukemia)
RecruitingPhase 2
Testing New Therapies for Patients With Acute Myeloid Leukemia Who Are Newly Diagnosed and Have Not Yet Started Treatment (A MyeloMATCH Treatment Trial)
Acute Myeloid Leukemia, Acute Myeloid Leukemia Arising From Previous Myelodysplastic/Myeloproliferative Neoplasm
Active, not recruitingPhase 2
Clofarabine and Melphalan Before Donor Stem Cell Transplant in Treating Patients With Myelodysplasia, Acute Leukemia in Remission, or Chronic Myelomonocytic Leukemia
Adult Acute Lymphoblastic Leukemia in Remission, Acute Myeloid Leukemia Arising From Previous Myelodysplastic Syndrome
RecruitingPhase 1/2
Venetoclax and CLAG-M for the Treatment of Acute Myeloid Leukemia and High-Grade Myeloid Neoplasms
Acute Biphenotypic Leukemia, Acute Myeloid Leukemia
Not yet recruitingPhase 1
ATRN-119 in Combination With Decitabine in Patients With TP53-Mutated AML or Higher-Risk MDS
Acute Myeloid Leukemia, High-risk Myelodysplastic Syndrome
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.
Huo Tan, MD principal investigator
Fifth Affiliated Hospital of Guangzhou Medical University
Runhui Zheng, MD study director
Fifth Affiliated Hospital of Guangzhou Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing iNK cells in people with Acute Myeloid Leukemia (AML), run by Guangzhou Ruixin Biotechnological Co., LTD at 1 site in China.
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 13 inclusion and 11 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 22 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Liu J Jianbo Liu, MD (+86-020-85959142, 332520646@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). The study lists 4 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 22 Nov 2024.