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Acute Myeloid LeukemiaPhase 1/2NCT05140811

A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

A Phase 1/2 study testing IMM01 and Azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 22 sites in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This trial is an open-lable , multi-center, Phase 1/Phase 2 study that will evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and and immunogenicity of IMM01 combined with Azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IMM01 and Azacitidine
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
126 participants
Where
22 sitesChina
Study dates
5 Jan 2022to 1 Mar 2024
Phase
Phase 1/2
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

  • Voluntary participation and written informed consent.
  • Males and females ≥18 years of age
  • The Eastern Oncology Collaboration (ECOG) Status of ≤2
  • Life expectancy of at least 3 months.
  • Women and men of reproductive age must agree and use effective contraception during the study period and for three months after the last administration of IMM01, and women of reproductive age must have negative pregnancy test results within seven days prior to administration.
  • White blood cell count ≤ 20×10⁹/L before the first treatment of the study drug (treatment with hydroxyurea is permitted, but not within 3 days before the first treatment of the study drug).
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  • Bone marrow aspiration and bone marrow biopsy were agreed during screening and treatment.
  • For those who have received previous chemotherapy or targeted drug therapy, the interval between the first drug administration should be more than 2 weeks;Prior treatment with chimeric antigen receptor T cells (CAR T cells) should be discontinued for at least 12 weeks after initial dosing(for Cohort 1 and 2).
  • Non-hematological adverse reactions have been restored to grade 1 and below (NCI-CTC AE v5.0, except residual hair loss effect),in patients with previous chemotherapy and targeted drug therapy. Hematologic adverse reactions recovered to investigatory-determined acceptance of study drug administration (for cohort 1 and 2).
  • Appropriate organ functions.

Who cannot join

  • Received anti-CD47 antibody or SIRPα fusion protein research drugs.
  • Who has received allogeneic hematopoietic stem cell transplantation and other organ transplants; Autologous hematopoietic stem cell transplantation less than six months.
  • Central nervous system leukemia orcentral nervous system invasion.
  • Developed other malignant tumors within 5 years prior to enrollment.Except:
  • Cured carcinoma in situ and non-melanoma skin cancer of the cervix; Complete remission of disease at least 2 years prior to initial administration and no need for antineoplastic therapy.
  • Patients with a history of active autoimmune diseases;
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  • Major surgery within 4 weeks prior to initial treatment;
  • Subjects requiring systemic corticosteroids (equivalent to >10 mg prednisone/day) or other immunosuppressive agents within 14 days prior to initial treatment or during the study period;
  • Hypertension (systolic blood pressure ≥ 140mmHg and/or diastolic blood pressure ≥ 90mmHg) or pulmonary hypertension or unstable angina that is also not controlled by medication;
  • Patients with a history of arterial or deep vein thrombosis within the 6 months prior to enrollment, or evidence or history of bleeding tendency within the 2 months prior to enrollment, regardless of severity.
  • Severe gastrointestinal diseases;
  • With acute lung disease, pulmonary fibrosis, Severe dyspnea, lung insufficiency or continuous oxygen inhalation.
  • Patients who have been severely infected within 4 weeks prior to initial administration;
  • Active hepatitis B or hepatitis C ; human immunodeficiency virus (HIV) antibody is positive.
  • Live attenuated vaccine should be administered within 4 weeks prior to initial administration.
  • Patients with a history of severe allergy to protein drugs (CTCAE V5.0 grade > 3); Or the patient is allergic to azacytidine.
  • Participate in clinical trials of other drugs 28 days prior to initial dosing.
  • A history of prior neurological or mental disorders, such as epilepsy, dementia, or alcohol, drug or substance abuse, affects compliance.
  • Other conditions that the investigator considers inappropriate for participation in this clinical trial.

Trial locations and contacts

22 sites in 1 country.

jinhua zhou contact

02138016387

jinhua.zhou@immuneonco.com

22 sites in 1 country

China22 sites, 22 recruiting

  • Beijing gobroad boren hospital

    Beijing

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Peking university third hospital

    Beijing

    yujuan Ma, yujuan.ma@immuneonco.com

    Not yet recruiting

  • Xuanwu Hospital, Capital Medical University

    Beijing

    Ronghua Hu, hurh@163.com

    Recruiting

  • Chongqing university cancer hospital

    Chongqing

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Second Affliated Hospital of Army Medical University

    Chongqing

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Fujian medical university union hospital

    Fuzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Ganzhou People's Hospital

    Ganzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Guangdong provincial people hospital

    Guangzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Nanfang Hospital, Southern Medical University

    Guangzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Zhujiang Hospital, Southern Medical University/The Second School of Clinical Medicine, Southern Medical University

    Guangzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • The first affiliated hospital zhejiang university school of medicine

    Hangzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • The first affiliated hospital of nanchang University

    Nanchang

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Shanghai sixth's hospital

    Shanghai

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Tongren hospital shanghai jiaotong university school of medicine

    Shanghai

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Shengjing Hospital Affiliated to China Medical University

    Shenyang

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • The First Hospital of China Medical University

    Shenyang

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Tianjin Blood Disease Hospital

    Tianjin

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • The affiliated hospital of Xuzhou medical university

    Xuzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • Henan Cancer Hospital

    Zhengzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

  • The first affiliated hospital of Zhengzhou University

    Zhengzhou

    yujuan Ma, yujuan.ma@immuneonco.com

    Recruiting

Other trials in China

About this study

Official title: Phase 1/Phase 2 Study of IMM01 Combined With Azacitidine in Patients With AML and MDS

This trial is an open-lable , multi-center, Phase 1/Phase 2 study that will evaluate the safety, tolerability, Pharmacokinetics, Pharmacodynamics and and immunogenicity of IMM01 combined with Azacitidine in patients with Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS).

Read the detailed description

Main study purpose:

  • To evaluate the safety and tolerability of IMM01 combined with Azacitidine in patients with AML and MDS.
  • To explore the Maximum Tolerated Dose (MTD) of IMM01 combined with Azacitidine, and determine the phase 2 clinical recommended dose (RP2D) of IMM01 combined with Azacitidine.

Secondary study purpose:

  • To evaluate the efficacy of IMM01 combined with Azacitidine in patients with AML and MDS.
  • To evaluate the Pharmacokinetics and Pharmacodynamics of IMM01 combined with Azacitidine, in patients with AML and MDS.

Exploratory study purpose:

  • To evaluate the immunogenicity of IMM01 combined with Azacitidine in patients with AML and MDS.
Being tested
IMM01, Azacitidine
Medical subject headings
Leukemia, Myeloid, Acute, Myelodysplastic Syndromes

What participants receive

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

  • IMM01Drug

    Also called IMM01 Ingection

    IMM01 is intravenously once a week, every 28 days for a treatment cycle;

  • AzacitidineDrug

    Also called Vidaza

    Azacitidine 75 mg/m/ day is administered subcutaneously for 7 consecutive days, with each 28-day treatment cycle planned for 6 treatment cycles

Study groups in NCT05140811
Study groupRoleWhat they receive
Relapse/Refractory AMLExperimentalIMM01 and Azacitidine in Relapse/Refractory AML Interventions: Drug: IMM01 Drug: Azacitidine
Receives: Drug: IMM01; Drug: Azacitidine
Relapsed or Refractory MDSExperimentalIMM01 and Azacitidine in Relapse/Refractory MDS Interventions: Drug: IMM01 Drug: Azacitidine
Receives: Drug: IMM01; Drug: Azacitidine
Treatment naive AMLExperimentalIMM01 and Azacitidine in treatment naive AML Interventions: Drug: IMM01 Drug: Azacitidine
Receives: Drug: IMM01; Drug: Azacitidine
Treatment naive MDS and naive CMMLExperimentalIMM01 and Azacitidine in treatment naive MDS and naive CMML Interventions: Drug: IMM01 Drug: Azacitidine
Receives: Drug: IMM01; Drug: Azacitidine

What is being measured

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

  1. Incidence rate and the grade (severity) of dose-limiting toxicities (DLTs) of IMM01 combination azacitidine

    To be summarized using descriptive statistics

    Measured: Though end of DLT evaluation period,up to approximately 28 days.

  2. Maximum Tolerated Dose (MTD)

    MTD is the highest dose in patients with DLT incidence <1/3.For a dose group to be assessed as MTD, at least 6 DLT data must be available to evaluate the subject.

    Measured: Dose-limiting toxicities will be evaluated during the first cycle (28 days) of treatment.

Secondary outcomes (6)

  1. Pharmacokinetics - Cmax

    Maximum observed concentration in serum

    Measured: Within 60 minutes prior to infusion on Cycle 1 Day 1, Day 8, Day 15 and Cycle 2-6 Day 1 (28 days cycle).10 minutes post-infusion on Cycle 1 Day 15 and Cycle 6 Day 22 (28 days cycle ) .10 minutes and 4 hours post-infusion on Cycle 1 Day 1 (28 days cycle).

  2. Pharmacokinetics - AUC

    Area under the serum concentration - time curve

    Measured: Within 60 minutes prior to infusion on Cycle 1 Day 1, Day 8, Day 15 and Cycle 2-6 Day 1 (28 days cycle).10 minutes post-infusion on Cycle 1 Day 15 and Cycle 6 Day 22 (28 days cycle ) .10 minutes and 4 hours post-infusion on Cycle 1 Day 1 (28 days cycle).

  3. Pharmacokinetics - tmax

    Time to peak (maximum) serum concentration

    Measured: Within 60 minutes prior to infusion on Cycle 1 Day 1, Day 8, Day 15 and Cycle 2-6 Day 1 (28 days cycle).10 minutes post-infusion on Cycle 1 Day 15 and Cycle 6 Day 22 (28 days cycle ) .10 minutes and 4 hours post-infusion on Cycle 1 Day 1 (28 days cycle).

  4. Pharmacokinetics - T1/2

    Terminal half-life (T1/2)

    Measured: Within 60 minutes prior to infusion on Cycle 1 Day 1, Day 8, Day 15 and Cycle 2-6 Day 1 (28 days cycle).10 minutes post-infusion on Cycle 1 Day 15 and Cycle 6 Day 22 (28 days cycle ) .10 minutes and 4 hours post-infusion on Cycle 1 Day 1 (28 days cycle).

  5. Response Rate

    Response determined per European LeukemiaNet response criteria:

    CR = bone marrow blasts <5%; absence of blasts with Auer rods; absence of extramedullary disease; absolute neutrophil count > 1.0 x 10e9/L; platelet count > 100 x 10e9/L; and independence of red cell transfusions.

    CRi = all CR criteria except for residual neutropenia (< 1.0 x 10e9/L) or thrombocytopenia (< 100 x 10e9/L)].

    To evaluate clinical benefit defined as CR, CRi, morphologic leukemia-free state, and partial remission (PR).

    Measured: When the last subject enrolled completes approximately 12 months of treatment

  6. Overall Remission (OR):

    Response Criteria are according to the Modified IWG (International Working Group) Response Criteria in Myelodysplasia.CR: bone marrow evaluation shows less than or equal to (<=) 5% blasts; normal maturation of all cells lines (mCR), peripheral blood evaluation shows hemoglobin >= 11 gram per deciliter (g/dL), neutrophils >= 1000/mL, platelets >= 100,000/mL, 0% blasts; PR: Same as CR, except blasts decrease by >=50%, still greater than 5% in bone marrow. Hematologic improvement are measured in participants with pretreatment abnormal values: hemoglobin level less than 110 g/L (11 g/dL) or red blood count (RBC)-transfusion dependence, platelet count <100 x 10^9/L or platelet-transfusion dependence, absolute neutrophil count (ANC) less than 1.0 x 10^9/L.

    Measured: When the last subject enrolled completes approximately 12 months of treatment

Timeline

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

  1. First posted1 Dec 2021
  2. Study start5 Jan 2022
  3. Primary completion5 Feb 2024 (estimated)
  4. Study completion1 Mar 2024 (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 1/2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
126 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05140811
Sponsor's protocol ID
IMM01-02
Status last verified
May 2023
First submitted
17 Oct 2021
Last updated
24 May 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ma L, Yang W, Gao S, Li J, Yin Q, Zhao X, Yan X, Tu S, Li F, Yang H, Hu R, Wang S, Dong Z, Zhao X, Lu G, Wu Z, Tian W, Tong H, Xiao Z. Timdarpacept (IMM01) combined with azacitidine (AZA) as first-line therapy in adults with higher risk chronic myelomonocytic leukemia (CMML): results from a prospective, multicenter, phase II study. Exp Hematol Oncol. 2026 Oct 28;15(1):115. doi: 10.1186/s40164-026-00851-8.

    PubMed 42958448

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing IMM01 and Azacitidine in people with Acute Myeloid Leukemia and Myelodysplastic Syndromes, run by ImmuneOnco Biopharmaceuticals (Shanghai) Inc. at 22 sites 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 10 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: status not confirmed, as of the sponsor's last update on 24 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 22 sites 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 jinhua zhou (02138016387, jinhua.zhou@immuneonco.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence rate and the grade (severity) of dose-limiting toxicities (DLTs) of IMM01 combination azacitidine (time frame: Though end of DLT evaluation period,up to approximately 28 days.). 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 NCT05140811, which also lists 1 linked publication.

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 24 May 2023.

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