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AML (Acute Myeloid Leukemia)Phase 1NCT06690827

Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/Refractory AML or BPDCN

A Phase 1 study testing Anti-CD123 CAR NK cells in people with AML (Acute Myeloid Leukemia) and BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm), run by Chongqing Precision Biotech Co., Ltd at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors. Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Anti-CD123 CAR NK cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
12 Dec 2024to 31 Oct 2028
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients of any gender, aged between 18 and 75 years (inclusive);
  • Positive expression of CD123 on tumor cells detected by flow cytometry;
  • Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN:
  • For AML patients：
  • Relapsed refers to the reappearance of leukemic cells in peripheral blood after complete remission (CR), or ≥5% blasts in bone marrow (excluding other reasons such as bone marrow regeneration after consolidation chemotherapy), or the presence of leukemic cell infiltration outside the marrow;
  • Refractory refers to patients who have not responded to two courses of standard treatment; patients who have relapsed within 12 months after CR and consolidation/intensification therapy; patients who have relapsed after 12 months but have not responded to conventional chemotherapy; patients with two or more relapses; patients with persistent extramedullary leukemia;
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  • For BPDCN patients: Patients who have not responded to or cannot tolerate the recommended salvage treatment according to guidelines, and have persistent or recurrent disease in any of the following: peripheral blood, bone marrow, lymph nodes, spleen, skin lesions, or other sites.
  • 4. Expected survival time of more than 12 weeks;
  • 5. ECOG score of 0-2 (Appendix 2);
  • 6. No severe mental disorders;
  • 7. Basic normal function of important organs:
  • Blood routine: white blood cells >1.0×109/L, neutrophils >0.5×109/L, lymphocytes >0.5×109/L, platelets >50×109/L;
  • Cardiac function: echocardiography indicates a left ventricular ejection fraction ≥50%, and no significant abnormalities on electrocardiogram;
  • Renal function: serum creatinine ≤2.0×ULN;
  • Liver function: ALT and AST ≤3.0×ULN (for patients with liver invasion
  • 5.0×ULN);
  • Total bilirubin ≤2.0×ULN (for patients with Gilbert's syndrome ≤3.0×ULN);
  • Blood oxygen saturation >92%. 8. The patient or their legal guardian agrees to participate in this clinical trial and signs the ICF, indicating their understanding of the purpose and procedures of the clinical trial and willingness to participate in the study.

Who cannot join

  • Presence of active central nervous system invasion during screening;
  • Receipt of anti-tumor therapies prior to screening, including chemotherapy, targeted therapy, or other experimental drug treatments within 14 days or at least 5 half-lives (whichever is shorter), except for those who have confirmed disease progression after treatment;
  • Occurrence of cerebrovascular accident or epileptic seizure within 6 months prior to screening;
  • Presence of active or uncontrolled infection requiring systemic treatment within 1 week prior to screening;
  • Presence of any of the following cardiac diseases:
  • Congestive heart failure at New York Heart Association (NYHA) class III or IV;
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  • Myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to enrollment;
  • Clinically significant ventricular arrhythmia, or history of unexplained syncope (excluding cases caused by vasovagal or dehydration);
  • History of severe non-ischemic cardiomyopathy;
  • Combination with active autoimmune diseases requiring long-term immunosuppressive therapy;
  • Presence of other malignancies, except for adequately treated carcinoma in situ of the cervix, basal cell or squamous cell carcinoma of the skin, localized prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery.
  • Receipt of live attenuated vaccines within 4 weeks prior to screening;
  • Pregnant or breastfeeding women, as well as male or female subjects who plan to have children within 1 year after receiving CAR-NK cell infusion;
  • Other conditions that the investigator deems unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Wei Jia, Professor contact

+86 13986102084 ext. （0351）837 9851

jiawei@tjh.tjmu.edu.cn

China1 site, 1 recruiting

  • Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology.

    Wuhan, Hubei, 430030

    Wei Jia, M.D., +86 13986102084, jiawei@tjh.tjmu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: Clinical Study of CD123 Targeting Chimeric Antigen Receptor NK Cells (CAR-NK) in the Treatment of Relapse/Refractory Acute Myeloid Leukemia (AML)or Blastic Plasmacytoid Dendritic Cell Neoplasm(BPDCN)

This is a clincal trial initiated by investigator to evaluate the safety and efficacy of anti-CD123 CAR-NK in the treatment of patients with relapsed/refractory acute myeloid leukemia or blastic plasma cell like dendritic cell tumors.

Read the detailed description

This study is a single-arm, open-label, dose-finding and expansion clinical trial aimed at evaluating the safety and efficacy of antiCD123 CAR-NK therapy for the treatment of patients with relapsed/refractory AML or BPDCN. The goal is to determine the recommended dose of CAR-NK cell therapy for these conditions. The study includes three dose groups: 1×107 CAR-positive cells/kg, 3×107 CAR-positive cells/kg, and 5×107 CAR-positive cells/kg. Each patient will receive two infusions of CAR-NK cells on D0 and D7, respectively, with the doses for both infusions principally remaining the same. However, the investigaors have the flexibility to adjust the second infusion dose based on the subject's condition.

Being tested
Anti-CD123 CAR NK cells
Keywords
CD123, AML, Acute Myeloid Leukemia, blastic plasmacytoid dendritic cell neoplasm, acute leukemia, Malignant Hematoma, CAR-NK, CD123 CAR-NK, Chimeric antigen natural killer cells
Medical subject headings
Leukemia, Myeloid, Acute, Blastic Plasmacytoid Dendritic Cell Neoplasm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Anti-CD123 CAR NK cellsDrug

    Each patient will receive two CAR-NK cell infusions at D0 and D7, and CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.

Study groups in NCT06690827
Study groupRoleWhat they receive
CD123 CAR-NK cellsExperimentalNot described
Receives: Drug: Anti-CD123 CAR NK cells

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]

    The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.

    Measured: 28 dyas

  2. Objective response rate (ORR), including complete response (CR) and partial response (PR), after CAR-NK infusion

    Measured: 1month, 2 months, 3 months

  3. overall survival (OS) after CAR-NK infusion

    Measured: 2 years

  4. Duration of response (DOR) after CAR-NK infusion

    Measured: 2 years

  5. recurrence free survival (RFS) after CAR-NK infusion

    Measured: 2 years

  6. event free survival (EFS) after CAR-NK cells infusion

    Measured: 2 years

Secondary outcomes (9)

  1. Dose limited toxicity (DLT) rate after CAR-NK infusion

    Measured: 1 month

  2. Cmax of anti-CD123 CAR-NK cells in humans

    Measured: 1 month

  3. Overall response rate (ORR) after anti-CD123 CAR-NK therapy in relapsed/refractory AML and BPDCN patients

    Measured: 1 year

  4. Tmax of anti-CD123 CAR-NK cells [Cell dynamics]

    Measured: 1 month

  5. AUCs of anti-CD123 CAR-NK cells [Cell dynamics]

    Measured: 1 month

  6. overall survival (OS) after anti-CD123 CAR-NK infusion in r/r AML and BPDCN patients

    Measured: 2 years

  7. duration of response (DOR) after anti-CD123 CAR-NK cells infusion in r/r AML and BPDCN patients

    Measured: 2 years

  8. Recurrence free survival (RFS) after anti-CD123 CAR-NK cells infusion in r/r AML and BPDCN patients

    Measured: 2 years

  9. Event free survival (EFS) after anti-CD123 CAR-NK cells infusion in r/r AML and BPDCN patients

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Nov 2024
  2. Study start12 Dec 2024
  3. Primary completion30 Jun 2027 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

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
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06690827
Sponsor's protocol ID
PBC065
Status last verified
Aug 2026
First submitted
10 Nov 2024
Last updated
28 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Anti-CD123 CAR NK cells in people with AML (Acute Myeloid Leukemia) and BPDCN (Blastic Plasmacytoid Dendritic Cell Neoplasm), run by Chongqing Precision Biotech 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 18 inclusion and 14 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: looking for participants now, as of the sponsor's last update on 28 Aug 2026. 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?

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 Wei Jia, Professor (+86 13986102084 ext. （0351）837 9851, jiawei@tjh.tjmu.edu.cn), 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 [Safety and Tolerability] (time frame: 28 dyas). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06690827.

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 28 Aug 2026.

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