Acute Myeloid Leukemia (AML)Phase 1NCT07198867
A Study of A-CAR028 Treatment in Subjects With Relapsed or Refractory Acute Myeloid Leukemia
A Phase 1 study testing A-CAR028 in people with Acute Myeloid Leukemia (AML) and CAR-T Cell Therapy, run by First Affiliated Hospital of Zhejiang University at 1 site in China.
Trial summary
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
- What is being tested?
- A-CAR028
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 30 Sep 2025to 31 Dec 2027
- 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
- 18 to 75 years old at the time of signing the Informed Consent Form (ICF)
- More than 12 weeks of expected survival
- ECOG score 0 or 1
- Relapsed or refractory AML
- Adequate organ function
Who cannot join
- Acute Promyelocytic Leukemia (APL)
- Mixed Phenotype Acute Leukemia (MPAL)
- Acute Undifferentiated Leukemia (AUL)
- Only extramedullary leukemia
- Known allergies to the components or excipients of the A-CAR028 cell product
- Severe heart diseases, including but not limited to, myocardial infarction, angioplasty or stent implantation within 12 months prior to signing the ICF, unstable angina pectoris, severe arrhythmia, history of severe non-ischemic cardiomyopathy, heart failure
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- Autologous or allogeneic hematopoietic stem cell transplantation within 3 months prior to signing the ICF
- Central nervous system (CNS) involvement or symptoms of CNS involvement (including cranial nerve lesions and extensive lesions or spinal cord compression)
- A stroke or seizure occurred within 12 months prior to signing the ICF
- Malignancy history within 5 years prior to signing the ICF
- Uncontrolled active infection
- Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Treponema Pallidum (TP) positive, Cytomegalovirus (CMV) DNA positive
- Live vaccine injection within 4 weeks prior to signing the ICF
- Acute or chronic graft-versus-host disease (GVHD) was present at screening
- Inadequate washing time for previous treatment
- Previously treated with CAR-T cell products or genetically modified T cell therapies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Department of Hematology, The First Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
Jie Jin, MD, +86-571-87236114, jiej0503@163.com
Huafeng Wang, MD
About this study
Official title: A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
This is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Read the detailed description
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit
- Conditions
- Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
- Being tested
- A-CAR028
- Keywords
- A-CAR028, Acute Myeloid Leukemia
- 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.
A-CAR028Biological
A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens
| Study group | Role | What they receive |
|---|---|---|
| A-CAR028 | Experimental | Autologous A-CAR028 administered by intravenous (IV) infusion Receives: Biological: A-CAR028 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of dose limiting toxicities (DLTs)
Measured: Throughout the 28 days post A-CAR028 infusion
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Measured: Throughout the 3 months post A-CAR028 infusion
Secondary outcomes (10)
Incidence and severity of Adverse Events (AEs)
Measured: Throughout the 2 years post A-CAR028 infusion
Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR)
Measured: Throughout the 2 years post A-CAR028 infusion
Duration of Response (DOR)
Measured: Throughout the 2 years post A-CAR028 infusion
Event-free Survival (EFS)
Measured: Throughout the 2 years post A-CAR028 infusion
Overall Survival (OS)
Measured: Throughout the 2 years post A-CAR028 infusion
Maximal plasma concentration (Cmax)
Measured: Throughout the 2 years post A-CAR028 infusion
Time to reach the maximal plasma concentration (Tmax)
Measured: Throughout the 2 years post A-CAR028 infusion
Area under the curve within 28 days (AUC0-28d)
Measured: Throughout the 2 years post A-CAR028 infusion
Time of last measurable observed concentration (Tlast)
Measured: Throughout the 2 years post A-CAR028 infusion
Changes of CD33/CLL-1 positive cells in bone marrow
Measured: Throughout the 2 years post A-CAR028 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start30 Sep 2025 (estimated)
- Primary completion30 Dec 2026 (estimated)
- Study completion31 Dec 2027 (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 (AML)Studies of the same condition, open and under way.
- More trials run by First Affiliated Hospital of Zhejiang UniversityThe sponsor's other registered studies.
- 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital of Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198867
- Sponsor's protocol ID
- 1207-047
- Status last verified
- Jun 2025
- First submitted
- 30 Jul 2025
- Last updated
- 30 Sep 2025
- 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 30 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of A-CAR028 Treatment in Subjects With Relapsed/ Refractory Acute Myeloid Leukemia
- ClinicalTrials.gov ID
- NCT07198867
- Acronym / sponsor ID
- 1207-047
- Conditions
- Acute Myeloid Leukemia (AML), CAR-T Cell Therapy
- Keywords
- A-CAR028, Acute Myeloid Leukemia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- First Affiliated Hospital of Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Shanghai AbelZeta Ltd.
- Study start
- 30 Sep 2025 (estimated)
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 30 Sep 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 is a single-center, open-label study to evaluate the safety and efficacy of A-CAR028 in relapsed/refractory acute myeloid leukemia patients
Detailed description
The study includes the following sequential phases: Screening, Apheresis and A-CAR028 manufacturing, Baseline testing, Lymphodepletion, A-CAR028 infusion, Dose-limiting toxicity observation and Follow-up Visit
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A-CAR028 | Experimental | Biological: A-CAR028Autologous A-CAR028 administered by intravenous (IV) infusion |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18 to 75 years old at the time of signing the Informed Consent Form (ICF)
- More than 12 weeks of expected survival
- ECOG score 0 or 1
- Relapsed or refractory AML
- Adequate organ function
Key exclusion criteria (16 listed)
- Acute Promyelocytic Leukemia (APL)
- Mixed Phenotype Acute Leukemia (MPAL)
- Acute Undifferentiated Leukemia (AUL)
- Only extramedullary leukemia
- Known allergies to the components or excipients of the A-CAR028 cell product
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 |
|---|---|---|
| A-CAR028A-CAR028 is a novel 2nd generation 4-1BB bispecific chimeric antigen receptor T-cell (CAR-T) targeting both CD33 and CLL-1 antigens | Biological | A-CAR028 |
Primary outcome
Incidence of dose limiting toxicities (DLTs)
Time frame: Throughout the 28 days post A-CAR028 infusion
Incidence and severity of Treatment Emergent Adverse Events (TEAEs)
Time frame: Throughout the 3 months post A-CAR028 infusion
10 secondary outcomes
Incidence and severity of Adverse Events (AEs)
Time frame: Throughout the 2 years post A-CAR028 infusion
Overall Response Rate (ORR): including Complete Response (CR), CR with Partial Hematologic Recovery (CRh), CR with Incomplete Hematologic Recovery (CRi), Morphologic Leukemia-free State (MLFS) and Partial Response (PR)
Time frame: Throughout the 2 years post A-CAR028 infusion
Duration of Response (DOR)
Time frame: Throughout the 2 years post A-CAR028 infusion
Event-free Survival (EFS)
Time frame: Throughout the 2 years post A-CAR028 infusion
Overall Survival (OS)
Time frame: Throughout the 2 years post A-CAR028 infusion
Maximal plasma concentration (Cmax)
Time frame: Throughout the 2 years post A-CAR028 infusion
Time to reach the maximal plasma concentration (Tmax)
Time frame: Throughout the 2 years post A-CAR028 infusion
Area under the curve within 28 days (AUC0-28d)
Time frame: Throughout the 2 years post A-CAR028 infusion
Time of last measurable observed concentration (Tlast)
Time frame: Throughout the 2 years post A-CAR028 infusion
Changes of CD33/CLL-1 positive cells in bone marrow
Time frame: Throughout the 2 years post A-CAR028 infusion
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 30 Sep 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing A-CAR028 in people with Acute Myeloid Leukemia (AML) and CAR-T Cell Therapy, run by First Affiliated Hospital of Zhejiang University 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 5 inclusion and 16 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 30 Sep 2025. 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 Jie Jin, MD (+86-0571-87236898, jiej0503@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of dose limiting toxicities (DLTs) (time frame: Throughout the 28 days post A-CAR028 infusion). The study lists 2 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 30 Sep 2025.