AML - Acute Myeloid LeukemiaEarly Phase 1NCT07201727
CD123+CLL-1 CAR-T Sequential Infusion With CD7 CAR-T and Bridging to Allo-HSCT for Relapsed/Refractory Acute Myeloid Leukemia
A Early Phase 1 study testing CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic in people with AML - Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, China.
Trial summary
This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- AML - Acute Myeloid Leukemia
- What is being tested?
- CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2025to 1 Jul 2028
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must meet all of the following criteria：
- Patients are clinically diagnosed with relapsed or refractory acute myeloid leukemia；
- Tumor cells are confirmed to be CD123 or CLL-1 positive by flow cytometry (FCM) or immunohistochemistry, with a positivity rate of no less than 80%；
- Patients aged 18 to 75 years (inclusive)；
- The expected survival time is more than 3 months from the date of signing the informed consent;
- KPS≥80 points;
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- The functions of vital organs need to meet the following conditions: ①LVEF>50%，and electrocardiogram is normal; ② Oxygen saturation ≥90%;③ SCr≤2.5ULN；④ALT and AST≤5ULN，TBil≤3ULN；
- Subjects intending to conceive must agree to use contraception prior to study enrollment and for six months post-study. In the event of pregnancy or suspected pregnancy, they should promptly notify the investigator.
- The subject or guardian understands and signs the Informed Consent Form (ICF).
Who cannot join
- Any of the following conditions will not be eligible for enrolment in this study:
- Within one - year prior to signing the informed consent form, there is a history of heart failure of New York Heart Association (NYHA) class ≥ III, or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other cardiac diseases with prominent clinical symptoms, or the QTc interval is > 480 ms during screening (the QTc interval is calculated by the Fridericia formula);
- Those with active GvHD or those who need to use immunosuppressants;
- Patients who have had any malignancy other than acute myeloid leukemia (AML) within the past 5 years, except for those with adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally resected prostate cancer, or resected ductal carcinoma in situ of the breast;
- Patients who have active infections requiring systemic treatment or uncontrollable infections within 7 days prior to screening, except for mild urinary and genital infections and upper respiratory infections;
- There has been a history of autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) that require systemic immunosuppressive/systemic disease regulatory drugs for treatment within the past two years;
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- When screening, if the hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HbcAb) is positive and the peripheral blood hepatitis B virus (HBV) DNA is higher than the detection limit, it needs to be excluded. If the hepatitis C virus (HCV) antibody is positive, those with positive HCV RNA in peripheral blood need to be excluded. Those who are positive for human immunodeficiency virus (HIV) antibodies; Those who test positive for cytomegalovirus (CMV) DNA; Those with positive DNA test for lymphotropic human herpesvirus (EBV); Those who test positive for Treponema pallidum specific antibody (TPPA) need to be excluded;
- Participation in another clinical trial within 4 weeks or within 5 half-lives of the last dose of the drug from the previous clinical trial (whichever is longer);
- Has a history of severe allergy to biological products;
- Unstable systemic diseases as judged by the investigator: including but not limited to severe liver, kidney or metabolic diseases requiring medical treatment;
- Pregnant or lactating women, female subjects who plan to become pregnant within 2 years after CAR-T cell infusion, or male subjects whose partners plan to become pregnant within 2 years after their CAR-T cell infusion;
- conditions that the investigator believes may increase the risk to the subject or interfere with the results of the trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Early Clinical Study of CD123+CLL-1 Dual-target CAR-T Cells Sequential Infusion CD7 CAR-T Cells and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
This study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.
Read the detailed description
This study is a single-arm, open-label, prospective clinical trial. It targets patients with relapsed/refractory acute myeloid leukemia (AML), planning to enroll 10 cases. The study will follow up and observe data related to adverse reactions and treatment efficacy after medication, aiming to evaluate the safety and efficacy of sequential therapy with two types of CAR-T cells.
- Conditions
- AML - Acute Myeloid Leukemia
- Being tested
- CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic
- Keywords
- Acute Myeloid Leukemia, CAR-T, Allogeneic hematopoietic stem cell transplantation, CD7, CD123, CLL1, CD123+CLL1
- 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.
CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneicBiological
For patients with refractory and relapsed AML, CD123+CLL-1 dual-target CAR-T cells (JY017) are used for treatment. Then, for patients who cannot achieve the minimum residual negative, CD7-targeted CAR-T cells (JY008) are sequentially infused. Finally, allogeneic hematopoietic stem cell transplantation is performed based on patient conditions.
| Study group | Role | What they receive |
|---|---|---|
| CD123+CLL-1 CAR-T sequential infusion with CD7 CAR-T and bridging to allo-HSCT | Experimental | Treat with CD123+CLL-1 dual-target CAR-T (JY017), then sequentially infuse CD7-targeted CAR-T (JY008) for patients not achieving MRD negativity, perform allo-HSCT based on patient conditions. Receives: Biological: CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Monitor and record adverse events
Measured: From CAR - T cell infusion to 2 years later.
Secondary outcomes (1)
Overall Response Rate
Measured: From CAR - T cell infusion to 2 years later .
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2025
- Study start30 Sep 2025 (estimated)
- Primary completion1 May 2028 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AML - 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, China
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07201727
- Sponsor's protocol ID
- IIT2025079
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 1 Oct 2025
- 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 1 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Clinical Study of CD123+CLL-1 Dual-target CAR-T Cells Sequential Infusion CD7 CAR-T Cells and Bridging to Allogeneic Hematopoietic Stem Cell Transplantation for the Treatment of Relapsed and Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07201727
- Acronym / sponsor ID
- IIT2025079
- Conditions
- AML - Acute Myeloid Leukemia
- Keywords
- Acute Myeloid Leukemia, CAR-T, Allogeneic hematopoietic stem cell transplantation, CD7, CD123, CLL1, CD123+CLL1
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 1 May 2028 (estimated)
- Study completion
- 1 Jul 2028 (estimated)
- First posted
- 1 Oct 2025 (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 study is a single-arm, open-label, prospective clinical trial, with patients suffering from refractory and relapsed acute myeloid leukemia as the subjects. It plans to enroll 10 cases to evaluate the safety and efficacy of sequential CD123+CLL-1 CAR-T cells followed by CD7 CAR-T cells treatment.
Detailed description
This study is a single-arm, open-label, prospective clinical trial. It targets patients with relapsed/refractory acute myeloid leukemia (AML), planning to enroll 10 cases. The study will follow up and observe data related to adverse reactions and treatment efficacy after medication, aiming to evaluate the safety and efficacy of sequential therapy with two types of CAR-T cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CD123+CLL-1 CAR-T sequential infusion with CD7 CAR-T and bridging to allo-HSCT | Experimental | Biological: CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneicTreat with CD123+CLL-1 dual-target CAR-T (JY017), then sequentially infuse CD7-targeted CAR-T (JY008) for patients not achieving MRD negativity, perform allo-HSCT based on patient conditions. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients must meet all of the following criteria：
- Patients are clinically diagnosed with relapsed or refractory acute myeloid leukemia；
- Tumor cells are confirmed to be CD123 or CLL-1 positive by flow cytometry (FCM) or immunohistochemistry, with a positivity rate of no less than 80%；
- Patients aged 18 to 75 years (inclusive)；
- The expected survival time is more than 3 months from the date of signing the informed consent;
Key exclusion criteria (12 listed)
- Within one - year prior to signing the informed consent form, there is a history of heart failure of New York Heart Association (NYHA) class ≥ III, or myocardial infarction, cardiac angioplasty or stent implantation, unstable angina pectoris, or other cardiac diseases with prominent clinical symptoms, or the QTc interval is > 480 ms during screening (the QTc interval is calculated by the Fridericia formula);
- Those with active GvHD or those who need to use immunosuppressants;
- Patients who have had any malignancy other than acute myeloid leukemia (AML) within the past 5 years, except for those with adequately treated cervical carcinoma in situ, basal cell or squamous cell carcinoma of the skin, locally resected prostate cancer, or resected ductal carcinoma in situ of the breast;
- Patients who have active infections requiring systemic treatment or uncontrollable infections within 7 days prior to screening, except for mild urinary and genital infections and upper respiratory infections;
- There has been a history of autoimmune diseases (such as rheumatoid arthritis, systemic lupus erythematosus, Crohn's disease) that require systemic immunosuppressive/systemic disease regulatory drugs for treatment within the past two years;
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+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneicFor patients with refractory and relapsed AML, CD123+CLL-1 dual-target CAR-T cells (JY017) are used for treatment. Then, for patients who cannot achieve the minimum residual negative, CD7-targeted CAR-T cells (JY008) are sequentially infused. Finally, allogeneic hematopoietic stem cell transplantation is performed based on patient conditions. | Biological | CD123+CLL-1 CAR-T sequential infusion with CD7 CAR-T and bridging to allo-HSCT |
Primary outcome
Monitor and record adverse events
Time frame: From CAR - T cell infusion to 2 years later.
1 secondary outcome
Overall Response Rate
Time frame: From CAR - T cell infusion to 2 years later .
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 1 Oct 2025.
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD123+CLL-1 dual-target CAR-T cells sequential infusion CD7 CAR-T cells and bridging to allogeneic in people with AML - Acute Myeloid Leukemia, run by Institute of Hematology & Blood Diseases Hospital, 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 12 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 1 Oct 2025. 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?
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 erlie Jiang (+86-15122538106, jiangerlie@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monitor and record adverse events (time frame: From CAR - T cell infusion to 2 years later.). 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 1 Oct 2025.