Acute Myeloid LeukemiaEarly Phase 1NCT04209712
Natural Killer Cells Infusion for Treating Acute Myeloid Leukemia Patients With Minimal Residual Disease
A Early Phase 1 study testing haploid allogeneic NK cell therapy in people with Acute Myeloid Leukemia, run by Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China at 1 site in China.
Trial summary
This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease. Read more about this study
- Who is it for?
- Ages 1 year to 80 years
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- haploid allogeneic NK cell therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2020to 31 Dec 2021
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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 1 year to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients diagnosed with acute myeloid leukemia;
- MRD after 2 course of standard chemotherapy;
- No plan for hematopoietic stem cell transplantation;
- Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L;
- Patients have self-knowledge ability and can sign informed and voluntary consent forms;
- Patients or their clients, guardians of pediatric patients signed the informed and voluntary consent form and joined the study.
Who cannot join
- Intracranial hypertension or unconsciousness;
- Symptomatic heart failure or severe arrhythmia;
- Respiratory failure;
- With other types of malignant tumor diseases;
- T lymphocytic acute leukemia;
- Diffuse intravascular;
Show all 15Show fewer
- Serum creatinine and / or urea nitrogen >=1.5 times the normal value;coagulation;
- Serum total bilirubin >=1.5 times the normal value;
- Sepsis or other difficult-to-control infections;
- Uncontrollable diabetes;
- severe mental disorders;
- WHO physical status classification >=3;
- People who are allergic to Interleukin-2;
- Patients after organ transplant;
- Pregnant and lactating women.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hebei Yanda Ludaopei Hospital
Langfang, Hebei, 065201
Jiang ZHU, +86-15900398802, zhujiang@icell.com.cn
About this study
Official title: Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia
This trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.
Read the detailed description
Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.
NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.
- Conditions
- Acute Myeloid Leukemia
- Being tested
- haploid allogeneic NK cell therapy
- 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.
haploid allogeneic NK cell therapyBiological
NK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2.
| Study group | Role | What they receive |
|---|---|---|
| haploid allogeneic NK cell therapy | Experimental | haploid allogeneic NK cell therapy with chemotherapy Receives: Biological: haploid allogeneic NK cell therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Minimal Residual Disease (MRD)
MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
Measured: 12 months
Secondary outcomes (1)
Number of participants with adverse events
Evaluation of toxicities defined as any CTCAE (v. 4.03)
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 posted24 Dec 2019
- Study start1 Jan 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2021 (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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- haploid allogeneic NK cell therapy with chemotherapy
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Responsible party
- Sponsor
- Investigators
- Xian Zhang, Principal investigator, Hebei Yanda Ludaopei Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209712
- Sponsor's protocol ID
- DS2019070101
- Status last verified
- Jul 2020
- First submitted
- 20 Dec 2019
- Last updated
- 29 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of Haploid Donor-derived in Vitro Activated Natural Killer Cells Infusion for Patients With Minimal Residual Disease After Consolidation Therapy for Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT04209712
- Acronym / sponsor ID
- DS2019070101
- Conditions
- Acute Myeloid Leukemia
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, ChinaIndustry (pharma, biotech, devices)
- Collaborators
- Hebei Yanda Ludaopei Hospital
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 24 Dec 2019 (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 trial will evaluate the effectiveness and safety of haploid donor-derived in vitro activated natural killer(NK) cells infusion for Treating acute myeloid leukemia Patients With minimal residual disease.
Detailed description
Patients of acute myeloid leukemia after chemotherapy with MRD(minimal residual disease) will receive NK cell infusion combined with consolidation chemotherapy. The bone marrow morphology and MRD remission of the patients will be observed 15 days after the same treatment. All patients will be followed up for 1 year.
NK cells are prepared in Beijing iCELL Biotechnology Co.,Ltd, which is subsidiary to Shanghai iCELL Biotechnology Co.,Ltd.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- haploid allogeneic NK cell therapy with chemotherapy
| Arm | Type | Receives |
|---|---|---|
| haploid allogeneic NK cell therapy | Experimental | Biological: haploid allogeneic NK cell therapyhaploid allogeneic NK cell therapy with chemotherapy |
Who may qualify
- Ages
- 1 year to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients diagnosed with acute myeloid leukemia;
- MRD after 2 course of standard chemotherapy;
- No plan for hematopoietic stem cell transplantation;
- Hemoglobin (Hb) >=60g/L, white blood cell count (WBC) >=2.5x10^9/L, platelet count >=30x10^9/L;
- Patients have self-knowledge ability and can sign informed and voluntary consent forms;
Key exclusion criteria (15 listed)
- Intracranial hypertension or unconsciousness;
- Symptomatic heart failure or severe arrhythmia;
- Respiratory failure;
- With other types of malignant tumor diseases;
- T lymphocytic acute leukemia;
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 |
|---|---|---|
| haploid allogeneic NK cell therapyNK cells will be intravenously infused to the patient for 2 days, with following subcutaneously injection of Interleukin-2. | Biological | haploid allogeneic NK cell therapy |
Primary outcome
Minimal Residual Disease (MRD)
Time frame: 12 months
MRD-negative is defined as <0.1% blasts with leukemia-associated phenotype detected by flow cytometry. MRD-positive is defined as >=0.1% blasts with leukemia-associated phenotype detected by flow cytometry.
1 secondary outcome
Number of participants with adverse events
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2020.
Related trials for Acute Myeloid Leukemia
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. This study is not recruiting at the moment.
Xian Zhang principal investigator
Hebei Yanda Ludaopei Hospital
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 haploid allogeneic NK cell therapy in people with Acute Myeloid Leukemia, run by Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 29 Jul 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang ZHU (+86-15900398802, zhujiang@icell.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Minimal Residual Disease (MRD) (time frame: 12 months). 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 29 Jul 2020.