Acute Myeloid Leukemia RefractoryEarly Phase 1NCT05574608
Allogenic CD123-CAR-NK Cells in the Treatment of Refractory/Relapsed Acute Myeloid Leukemia
A Early Phase 1 study testing CD123-CAR-NK cells in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia Recurrent, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myeloid Leukemia Refractory, Acute Myeloid Leukemia Recurrent
- What is being tested?
- CD123-CAR-NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2022to 30 Oct 2024
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old, no gender or race;
- Expected survival period ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met one of the following criteria:
- Diagnostic criteria for relapsed AML: after complete remission (CR), leukemia cells reappeared in peripheral blood or blast cells in bone marrow ≥ 5% (except for other reasons such as bone marrow regeneration after consolidation chemotherapy) or extramedullary leukemia cell infiltration; B. Diagnostic criteria for refractory AML: naive patients who were ineffective after 2 courses of standard regimens; patients relapsed within 12 months who underwent consolidation and intensive therapy after CR; patients relapsed after 12 months but were ineffective after conventional chemotherapy; Patients with two or more relapses; patients with persistent extramedullary leukemia; C. Patients eligible for relapsed or refractory AML remained minimally residual disease positive after salvage therapy
- Adequate organ function:
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- Liver function: ALT≤3×ULN, AST≤3×ULN, total bilirubin≤2×ULN; B. Coagulation function: international normalized ratio (INR) or activated partial thromboplastin time (APTT) ≤ 1.5×ULN; C. Renal function: serum creatinine≤1.5×ULN or creatinine clearance rate ≥30mL/min; D. Cardiac function: Left ventricular ejection fraction (LVEF) ≥ 50%;
- Women of child-bearing potential and all male participants must use effective methods of contraception for at least 12 months after infusion.;
- Informed Consent/Assent: All subjects must have the ability to understand and the willingness to sign a written informed consent.
Who cannot join
- Central nervous system involved;
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
- Systemic use of hormones within 2 weeks prior to enrollment (except for patients with inhaled corticosteroids);
- Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
- History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
- Patients cannot guarantee effective contraception (condom or contraceptives, etc.) within 1 years after enrollment;
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- Women who are pregnant (urine/blood pregnancy test positive) or lactating;
- Suffering from a serious autoimmune disease or immunodeficiency disease; 9 Suffering from mental illness;
- 10. Known alcohol dependence or drug dependence; 11. According to the investigator's judgment, the patient has other unsuitable grouping conditions.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital
Beijing, Beijing Municipality, 100071
Liangding Hu, Ph.D, +86-010-6694-7171, huliangding@sohu.com
Yao Sun, Ph.D, +86-010-6694-7172, suny320@126.com
About this study
Official title: Early Clinical Study of Allogenic CD123-CAR-NK Cells (JD023 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia
The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.
Read the detailed description
This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
- Being tested
- CD123-CAR-NK cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD123-CAR-NK cellsBiological
CD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Experimental: CD123-CAR-NK. | Experimental | The relapsed/refractory AML patients will receive allogenic CD123-Targeted CAR-NK cells infusion (1x10^9, 1-2x10^7/kg) after precondition chemotherapy. Receives: Biological: CD123-CAR-NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose limiting toxicities (DLTs)
Measured: 1 Months
Treatment-emergent adverse events
Measured: 3 months
Treatment-related adverse events
Measured: 3 months
Secondary outcomes (6)
Complete response (CR)
Measured: 3 months
Progression free survival (PFS)
Measured: 12 months
Overall Survival (OS)
Measured: 12 months
Proportion of subjects with minimal-residual disease (MRD) negative response
Measured: 3 months
The area under the concentration time-curve (AUC) of CD123-CAR-NK cells
Measured: 3 Months
Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax)
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2022
- Study start1 Oct 2022
- Primary completion30 Oct 2023 (estimated)
- Study completion30 Oct 2024 (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 RefractoryStudies 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
- Sequential
- Model description
- Evaluate the safety of JD023 injection.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Beijing JD Biotech Co. LTD.
- Responsible party
- Sponsor
- Investigators
- Liangding Hu, Docotr, Principal investigator, The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05574608
- Sponsor's protocol ID
- CAR-NK123-JD
- Status last verified
- Apr 2023
- First submitted
- 28 Sep 2022
- Last updated
- 26 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Study of Allogenic CD123-CAR-NK Cells (JD023 Injection) in the Treatment of Refractory or Relapsed CD123-positive Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT05574608
- Acronym / sponsor ID
- CAR-NK123-JD
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Beijing JD Biotech Co. LTD.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Oct 2023 (estimated)
- Study completion
- 30 Oct 2024 (estimated)
- First posted
- 10 Oct 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.
The CD123-Targeted CAR-NK cell therapy is a new treatment that is being investigated for treatment of acute myeloid leukemia (AML). The purpose of this study is to evaluate the safety of CD123-CAR NK cells given to these patients.
Detailed description
This is a study of allogenic CD123-CAR NK cells. The relapsed/refractory AML patients will receive FC (F, Fludarabine, C, Cyclophosphamide) chemotherapy followed by infusion of CD123-CAR-NK cells. No graft-versus-host disease (GVHD) prevention will be conducted before or after infusion. Dose-limiting toxicity, incidence of adverse events, disease response and PK/PD will be detected post-infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Evaluate the safety of JD023 injection.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Experimental: CD123-CAR-NK. | Experimental | Biological: CD123-CAR-NK cellsThe relapsed/refractory AML patients will receive allogenic CD123-Targeted CAR-NK cells infusion (1x10^9, 1-2x10^7/kg) after precondition chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age ≥ 18 years old, no gender or race;
- Expected survival period ≥ 3 months;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 2;
- The diagnosis of AML with bone marrow biopsy, immunohistochemistry or Flow cytometry definitively positive for CD123 and met one of the following criteria:
- Adequate organ function:
Key exclusion criteria (9 listed)
- Central nervous system involved;
- Known contraindication to the protocol defined lymphodepleting chemotherapy regimen of fludarabine/cyclophosphamide;
- Systemic use of hormones within 2 weeks prior to enrollment (except for patients with inhaled corticosteroids);
- Any active infection requiring systemic therapy by intravenous infusion within 14 days prior to the first dose of study drug, including: HBV, HCV, HIV, syphilis infection, or active pulmonary tuberculosis.
- History of hypersensitivity reactions to murine protein-containing products, or macromolecular biopharmaceuticals such as antibodies or cytokines;
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 |
|---|---|---|
| CD123-CAR-NK cellsCD123-CAR-NK is an allogenic CD123-Targeted chimeric antigen receptor NK-cell (CAR-NK) therapy. | Biological | Experimental: Experimental: CD123-CAR-NK. |
Primary outcome
Dose limiting toxicities (DLTs)
Time frame: 1 Months
Treatment-emergent adverse events
Time frame: 3 months
Treatment-related adverse events
Time frame: 3 months
6 secondary outcomes
Complete response (CR)
Time frame: 3 months
Progression free survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 12 months
Proportion of subjects with minimal-residual disease (MRD) negative response
Time frame: 3 months
The area under the concentration time-curve (AUC) of CD123-CAR-NK cells
Time frame: 3 Months
Peak levels of CD123-CAR-NK cells (maximum concentration or Cmax)
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Liangding Hu, Docotr principal investigator
The Fifth Medical Center of Chinese People's Liberation Army (PLA) General Hospital, Beijing, China.
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 CD123-CAR-NK cells in people with Acute Myeloid Leukemia Refractory and Acute Myeloid Leukemia Recurrent, run by Affiliated Hospital to Academy of Military Medical Sciences 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 9 inclusion and 9 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 26 Apr 2023. 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 Liangding Hu, Doctor (+86 01066947171, huliangding@sohu.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose limiting toxicities (DLTs) (time frame: 1 Months). The study lists 3 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 26 Apr 2023; AzTrials last refreshed its copy on 8 Nov 2026.