AzTrials
AzTrials

Acute Myeloid LeukemiaPhase 1NCT06234904

Study of IBR733 Cell Injection in Acute Myeloid Leukemia

A Phase 1 study testing IBR733 Cell Injection in people with Acute Myeloid Leukemia, run by Imbioray (Hangzhou) Biomedicine 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 an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed/refractory acute… Read more about this study

Who is it for?
Ages 18 to 74 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
IBR733 Cell Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
18 participants
Where
1 siteChina
Study dates
26 Mar 2024to 1 Jul 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 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects volunteer to participate in this clinical study, are fully aware of the study and have signed the Informed Consent Form (ICF). Subjects are willing to follow and able to complete all trial procedures.
  • Age: 18-74 (both inclusive), female or male.
  • Patients with AML (including secondary AML) diagnosed according to the WHO 2022 criteria.
  • Patients with AML who meet one of the following criteria: (1) Relapsed AML: reoccurrence of leukemia cells in peripheral blood or ≥5% blasts in bone marrow after complete remission (excluding other causes such as bone marrow regrowth after consolidation chemotherapy); (2) Refractory AML: treatment-naive patients who failed to respond to 2 courses of standard treatment; The patients relapsed within 12 months after consolidated intensive treatment; Patients who relapsed after 12 months but failed to respond to conventional chemotherapy (only once); Patients who are relapsed twice; (3) Patients received up to 3 additional cycles of chemotherapy or targeted therapy after the diagnosis of relapsed/refractory AML.
  • Eastern Cooperative Oncology Group (ECOG) score ≤2.
  • Subjects of reproductive age and their partners should agree to have no family planning and to use effective contraceptive methods for 6 months from signing the ICF until the last dose of the study drug is administered.
  • Expected survival time ≥3 months.

Who cannot join

  • Acute promyelocytic leukemia.
  • Chronic myeloid leukemia with myeloid blast crisis.
  • Clinically symptomatic central nervous system involvement (no need for lumbar puncture).
  • Subjects who have undergone an allogeneic hematopoietic stem cell transplantation or other organ transplantation.
  • Subjects who have undergone autologous hematopoietic stem cell transplantation less than 3 months before the first dose of treatment.
  • Subjects who have received cell immunotherapy such as chimeric antigen receptor-modified T cells (CAR-T), chimeric antigen receptor-natural killer cells (CAR-NK), and T cell receptor gene-modified T cells (TCR-T).
Show all 19Show fewer
  • Subjects who have received systemic antitumor therapy (except hydroxyurea) within 2 weeks before the first dose of study drug, including chemotherapy, immunotherapy, etc..
  • Subjects who have had other malignant tumors within 3 years before inclusion, except for any type of carcinoma in situ that has been cured in the past and cured skin basal cell carcinoma or skin squamous cell carcinoma.
  • The absolute peripheral blood blast count (ABC) > 40.0×10^9/L (ABC= total white blood cell count × blast %). The total white blood cell count can be controlled with hydroxyurea, but it must be stopped three days before the first dose of study drug or lymphodepletion.
  • Organ function: (1) Aspartate aminotransferase (AST) and alanine aminotransferase (ALT)>3 times upper limit of normal (ULN); If AST was elevated due to leukemia but liver function was normal (e.g., normal ALT, alkaline phosphatase, and direct/indirect bilirubin measurements), participants could be enrolled after investigator consent was obtained; (2) Serum total bilirubin >2.5×ULN (not applicable to patients with Gilbert's syndrome); (3) Creatinine clearance <45mL/min (estimated by Cockcroft-Gault formula) or creatinine >2×ULN; (4) Activated partial thromboplastin time >1.5×ULN or international normalized ratio >1.5×ULN.
  • Subjects whose cardiac function and disease meet one of the following conditions within 6 months before the first administration: (1) Any risk factors that increase QTcF (Fridericia formula) interval prolongation, such as uncorrectable hypokalemia, hereditary long QT syndrome, and use of drugs that prolong the QTcF interval; (2) New York Heart Association (NYHA) classification ≥Grade 3; (3) Unstable angina pectoris, and myocardial infarction; (4) Left ventricular ejection fraction <50% in resting state; (5) Clinically significant pericardial effusion determined by echocardiography.
  • Subjects who have a history of autoimmune diseases (such as Crohn's disease, rheumatoid arthritis, systemic lupus erythematosus, etc.) that require systemic immunosuppressive/systemic disease modulating drugs within 2 years before the first administration.
  • Active hepatitis B (e.g., DNA copy number > 1000 cps/mL if only hepatitis B surface antigen is positive), active hepatitis C virus infection (anti-hepatitis C antibody positive and HCV RNA positive), or human immunodeficiency virus antibody positive.
  • Women who are pregnant or lactating.
  • Subjects who have received major surgery (for the definition of major surgery, refer to the Level 3 and 4 surgeries specified in the Administrative Measures for the Clinical Application of Medical Technology) within 28 days before the first administration.
  • Subjects who have a history of alcohol, drug use or drug abuse in the past year;
  • Subjects who have participated in other clinical trials and received any unmarketed investigational drug or treatment within 4 weeks prior to first use of the study drug.
  • Subjects who are known to be allergic to the main components of the study drug.
  • Subjects who have other severe, acute, or chronic diseases or laboratory abnormalities that may increase the risk of participating in the study and receiving the study drug, or may interfere with the interpretation of study results.

Trial locations and contacts

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

Depei Wu, MD, PhD contact

67781856 ext. 0512

wudepei@suda.edu.cn

Xiaowen Tang, MD, PhD contact

67781856 ext. 0512

tangxiaowen@suda.edu.cn

China1 site, 1 recruiting

  • The First Affiliated Hospital of Soochow University

    Suzhou, Jiangsu, 215006

    Depei Wu, MD, PhD, 67781856 ext. 0512, wudepei@suda.edu.cn

    Xiaowen Tang, MD, PhD, 67781856 ext. 0512, tangxiaowen@suda.edu.cn

    Recruiting

Other trials in China

About this study

Official title: An Open-label, Multi-center, Phase I Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of IBR733 Cell Injection in Acute Myeloid Leukemia

This is an open-label clinical study: phase Ia is the dose-escalation part, and phase Ib is the dose-expansion part. The phase Ia study is to evaluate the safety, tolerability, recommended phase II dose, pharmacokinetics, immunogenicity and preliminary efficacy of IBR733 cell injection in relapsed/refractory acute myeloid leukemia (AML).

Read the detailed description

Phase Ia is the dose escalation part which adopts the "3+3" dose escalation design protocol. The dose is respectively 5.0×10^9 cells, 7.5×10^9 cells and 10.0×10^9 cells. 3-6 subjects will be enrolled at every dose level. Subjects who have signed the Informed Consent Form (ICF) will be reviewed for inclusion/exclusion criteria (this process is called "screening"), and eligible subjects will be treated with IBR733 cell injection after lymphodepletion therapy. The administration of IBR733 cell injection is performed on day 1 and day 8 of each cycle (21 days). The first and second subjects in the same group shall be enrolled at an interval of at least 21 days, for the purpose of ensuring their safety.

Being tested
IBR733 Cell Injection
Keywords
AML, R/R AML
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.

  • IBR733 Cell InjectionBiological

    The minimum initial dose is 5.0×10^9 cells and then escalate to 7.5×10^9 cells and 10.0×10^9 cells. Every 21 days is one cycle, and intravenous infusion is performed on day 1 and day 8 of each cycle.

Study groups in NCT06234904
Study groupRoleWhat they receive
IBR733 Cell InjectionExperimentalNot described
Receives: Biological: IBR733 Cell Injection

What is being measured

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

  1. Incidence of dose limiting toxicity (DLT)

    To evaluate the safety, tolerability, and determine the RP2D of IBR733 cell injection

    Measured: From day1 to day 21

  2. The incidence and severity of adverse events (AEs)

    To evaluate the safety of IBR733 cell injection

    Measured: From day 1 to day 30 after the last dose

Secondary outcomes (7)

  1. Complete remission rate (CRR)

    The rate of subjects who achieved complete remission (CR) among all subjects

    Measured: From day 1 up to 6 weeks

  2. Composite complete remission rate

    The rate of subjects achieving complete remission (CR) and complete remission with incomplete hematologic recovery (CRi) or complete remission with partial hematologic recovery (CRh) among all subjects

    Measured: From day 1 up to 6 weeks

  3. Objective remission rate (ORR)

    The rate of subjects achieving CR, CRi, morphologic leukemia-free state(MLFS), and partial remission(PR) among all subjects

    Measured: From day 1 up to 6 weeks

  4. Duration of remission (DOR)

    Time from the subject's first assessment of the onset of remission to the first assessment of disease recurrence or progression or death from any cause

    Measured: From day 1 up to 3 months

  5. Overall survival (OS)

    Time from the start of treatment to death from any cause

    Measured: From day 1 up to 3 months

  6. The number of IBR733 cells

    Blood samples will be collected at specified time points to detect the number of IBR733 cells in peripheral blood

    Measured: From day1 to day 21

  7. Anti-drug antibodies

    Blood samples will be collected at specified time points to detect anti-drug antibodies

    Measured: From day1 up to 6 weeks

Timeline

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

  1. First posted31 Jan 2024
  2. Study start26 Mar 2024
  3. Primary completion1 Jul 2027 (estimated)
  4. Study completion1 Jul 2027 (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
Sequential
Masking
None (open label)
Enrolment
18 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06234904
Sponsor's protocol ID
IBR733-101
Status last verified
Jul 2026
First submitted
21 Jan 2024
Last updated
2 Jul 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 IBR733 Cell Injection in people with Acute Myeloid Leukemia, run by Imbioray (Hangzhou) Biomedicine 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 7 inclusion and 19 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 2 Jul 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 Depei Wu, MD, PhD (67781856 ext. 0512, wudepei@suda.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of dose limiting toxicity (DLT) (time frame: From day1 to day 21). 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?

On the ClinicalTrials.gov record for NCT06234904.

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 2 Jul 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in