Relapsed / Refractory Myelodysplastic SyndromesEarly Phase 1NCT05371730
A Trial to Evaluate the Safety and Efficacy of NK Cells in Subjects With Myelodysplastic Syndromes
A Early Phase 1 study testing NCR300 in people with Relapsed / Refractory Myelodysplastic Syndromes, run by Nuwacell Biotechnologies Co., Ltd..
Trial summary
A clinical study to Evaluate the Safety and Efficacy of NK cells in the treatment of Myelodysplastic Syndromes Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed / Refractory Myelodysplastic Syndromes
- What is being tested?
- NCR300
- 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 May 2022to 30 Apr 2026
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects should voluntarily participate in this clinical study, are fully aware of the study, have signed the Informed Consent Forms, and are willing to follow and able to complete all trial procedures.
- Subjects who are more than 18 years old (including 18 years old), and less than 75 years old (including 75 years old).
- Subjects who are diagnosed as Myelodysplastic Syndromes(MDS) according to the IWG 2016 diagnosis criteria.
- Subjects who are diagnosed as relapsed or refractory MDS according to the IWG 2006 response criteria.
- Subjects who don't accept nor be suitable for HSCT.
- With the expected survival phase>3 months, subjects whose performance status scores of the Eastern Cooperative Oncology Organization (ECOG) are≤3.
- Except for the exclusion of blood transfusion and granulocyte-stimulating factor drugs, the subjects should meet the following conditions :Hemoglobin（HGB）> 60g/L,platelet count（PLT）> 30 × 10^9 / L, white blood cell count（WBC）> 1.0 × 10^9 / L,neutrophil（ NE）> 0.5 × 10^9 / L.
- "8.Organ function should meet the following criteria: Aspartate aminotransferase (AST), alanine aminotransferase (ALT) and total bilirubin(TBIL) ≤ 2 times the upper limit of normal (ULN)； serum creatinine（Scr）≤ 1.5 times ULNl ;international normalized ratio(INR)≤ 2 times ULNl or activeated partial thromboplasting time(APTT)≤ 1.5 times ULNl ." 9.According to the Common Terminology Criteria for Adverse Event ( CTCAE ) Version 4.0 ,all of AEs caused by pre-treatment have returned to the grade 1.
Who cannot join
- Bone marrow blasts>20%.
- Bone marrow fibrosis in diagnostic bone marrow biopsy.
- Subjects who have received immunosuppressive therapy (such as antithymocyte globulin,Cyclosporine,Mycophenolate mofetil ,Sirolimus,Etanercept,Alemtuzumab etc.) or thrombopoietin receptor agonists (such as Romiplostim,Herombopag Olamine,Recombinant Human TPO etc.) within 1 month before enrollment.
- Subjects who have received HSCT or other organ transplantations.
- Subjects who have uncontrolled active systemic fungal, bacterial or viral infections.
- When the virological test during the screening period shows that any of the following is met:positive test for the human immunodeficiency virus antibody, Hepatitis B surface antigen (HBsAg) and / or Hepatitis B core antibody (anti-HBc) and hepatitis B virus deoxyribonucleic acid > 10^3 copies / mL, Hepatitis C antibody (anti-HCV) or Treponema pallidum specific antibody(TPHA).
Show all 13Show fewer
- Subjects who are known to be allergic to the study drug and/or main components and/or any excipients of the study drug.
- "8.Serious organ dysfunction or disease involving the heart, kidney, or liver, such as Respiratory failure.
- New York Heart Association classification stage II, III, or IV congestive heart failure,QT interval prolongation,decompensated liver or renal insufficiency,uncontrolled hypertension ( > 160 / 100mmHg ) and dyslipidemia despite active treatment." 9.Active thrombosis,subjects who have a history of cardiovascular or cerebrovascular thrombotic events within 12 months.
- 10.Subjects who have had other uncured tumors within 5 years. 11.Subjects who have participated in any other clinical trials within 1 month before screening (excluding those who failed the screening or did not use study drugs for other reasons).
- 12.Subjects who have a history of alcohol, drug use or drug abuse. 13.Subjects who have a history of mental disorder. 14.Subjects who have potential health or social status (such as other severe, acute, chronic diseases laboratory abnormalities etc.) that may increase the risk of participating in the study and receiving the study drug, or may interfere with the interpretation of study results.
- 15.Pregnant women, lactating women, women of childbearing age who do not take appropriate contraceptive measures during the trial period (sterilization, intrauterine device, oral contraceptives or barrier contraception).
- 16.Subjects who are judged by the investigator to be unsuitable to participate in the trial.
Trial locations and contacts
No sites are listed yet.
About this study
A clinical study to Evaluate the Safety and Efficacy of NK cells in the treatment of Myelodysplastic Syndromes
Read the detailed description
This is a single arm, open-label, single-center pilot study. In this study, 15 patients will be enrolled. The primary purpose is to explore the safety including incidence of adverse events and serious adverse events.The secondary purpose is to explore the efficacy.
- Being tested
- NCR300
- Medical subject headings
- Myelodysplastic Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NCR300Drug
Intravenous infusion of NK cells（NCR300）
| Study group | Role | What they receive |
|---|---|---|
| NK cells | Experimental | Not described Receives: Drug: NCR300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE or SAE
The incidence of AE or SAE of NK cells infusion
Measured: From infusion day 365
Secondary outcomes (2)
Bone Marrow Morphology
The proportion of bone marrow blasts after NK cells infusions.
Measured: 58 days after initial infusion
Objective response rate (ORR)
ORR (sum of CR and PR) after NK cells infusions
Measured: 58 days 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 posted12 May 2022
- Study start30 May 2022 (estimated)
- Primary completion30 May 2025 (estimated)
- Study completion30 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed / Refractory Myelodysplastic SyndromesStudies 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Responsible party
- Principal investigator, Xiaoyu Zhu, M.D., Ph.D., The First Affiliated Hospital of University of Science and Technology of China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371730
- Sponsor's protocol ID
- AF/SC-12/02.0
- Status last verified
- May 2022
- First submitted
- 7 May 2022
- Last updated
- 12 May 2022
- 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 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate the Safety and Efficacy of NK Cells in Subjects With Myelodysplastic Syndromes
- ClinicalTrials.gov ID
- NCT05371730
- Acronym / sponsor ID
- AF/SC-12/02.0
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Nuwacell Biotechnologies Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of University of Science and Technology of China
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 30 May 2025 (estimated)
- Study completion
- 30 Apr 2026 (estimated)
- First posted
- 12 May 2022 (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 clinical study to Evaluate the Safety and Efficacy of NK cells in the treatment of Myelodysplastic Syndromes
Detailed description
This is a single arm, open-label, single-center pilot study. In this study, 15 patients will be enrolled. The primary purpose is to explore the safety including incidence of adverse events and serious adverse events.The secondary purpose is to explore the efficacy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NK cells | Experimental | Drug: NCR300 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects should voluntarily participate in this clinical study, are fully aware of the study, have signed the Informed Consent Forms, and are willing to follow and able to complete all trial procedures.
- Subjects who are more than 18 years old (including 18 years old), and less than 75 years old (including 75 years old).
- Subjects who are diagnosed as Myelodysplastic Syndromes(MDS) according to the IWG 2016 diagnosis criteria.
- Subjects who are diagnosed as relapsed or refractory MDS according to the IWG 2006 response criteria.
- Subjects who don't accept nor be suitable for HSCT.
Key exclusion criteria (13 listed)
- Bone marrow blasts>20%.
- Bone marrow fibrosis in diagnostic bone marrow biopsy.
- Subjects who have received immunosuppressive therapy (such as antithymocyte globulin,Cyclosporine,Mycophenolate mofetil ,Sirolimus,Etanercept,Alemtuzumab etc.) or thrombopoietin receptor agonists (such as Romiplostim,Herombopag Olamine,Recombinant Human TPO etc.) within 1 month before enrollment.
- Subjects who have received HSCT or other organ transplantations.
- Subjects who have uncontrolled active systemic fungal, bacterial or viral infections.
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 |
|---|---|---|
| NCR300Intravenous infusion of NK cells（NCR300） | Drug | NK cells |
Primary outcome
AE or SAE
Time frame: From infusion day 365
The incidence of AE or SAE of NK cells infusion
2 secondary outcomes
Bone Marrow Morphology
Time frame: 58 days after initial infusion
Objective response rate (ORR)
Time frame: 58 days after initial infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
Related trials for Relapsed / Refractory Myelodysplastic Syndromes
RecruitingPhase 1/2
Study of R289 in Patients With Lower-risk Myelodysplastic Syndromes (LR MDS)
Low Risk Myelodysplastic Syndromes
RecruitingPhase 1
First-in-human (FIH) Trial of GEN3018 in Relapsed or Refractory (R/R) Acute Myeloid Leukemia (AML) or Higher-risk Myelodysplastic Syndrome (HR-MDS)
R/R AML, R/R HR-MDS
Active, not recruitingPhase 1/2
Quizartinib, Decitabine, and Venetoclax in Treating Participants With Untreated or Relapsed Acute Myeloid Leukemia or High Risk Myelodysplastic Syndrome
Acute Myeloid Leukemia, Myelodysplastic Syndrome
Active, not recruitingPhase 2
Trametinib in Treating Patients With Relapsed or Refractory Juvenile Myelomonocytic Leukemia
Juvenile Myelomonocytic Leukemia, Neurofibromatosis Type 1
RecruitingPhase 1/2
Venetoclax With Combination Chemotherapy in Treating Patients With Newly Diagnosed or Relapsed or Refractory Acute Myeloid Leukemia
High Risk Myelodysplastic Syndrome, Recurrent Acute Myeloid Leukemia
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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing NCR300 in people with Relapsed / Refractory Myelodysplastic Syndromes, 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 8 inclusion and 13 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 12 May 2022. 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?
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 Hong Du, M.D. (13811846375, hdu@nuwacell.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE or SAE (time frame: From infusion day 365). 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 12 May 2022.