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New hope for rare leukemia: phase 3 trial of IMM01 combo launches

NCT ID NCT06647862

Disease control Sponsor: ImmuneOnco Biopharmaceuticals (Shanghai) Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This Phase 3 trial tests whether adding IMM01 (Timdarpacept) to standard azacitidine improves outcomes for people newly diagnosed with chronic myelomonocytic leukemia (CMML). About 170 participants will receive either the combination or a placebo plus azacitidine. The main goals are complete remission and overall survival.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
IMM01 (Timdarpacept) combined with azacitidine
What this could lead to
If successful, this combination could become a new standard treatment for chronic myelomonocytic leukemia, improving remission rates and overall survival.
What could go wrong
This is an early Phase 3 trial with 170 participants, so results may not confirm benefit. The drug combination may cause side effects like infusion reactions or bone marrow suppression.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 170 people

The number the study aims to enrol. It can still change while the study runs.

Started

Nov 2024

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Age ≥ 18 years old, regardless of gender; * Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1. * Life expectancy ≥ 12 weeks; * Patients with CMML diagnosed according to WHO 2016 criteria, including CMML-1 and CMML-2; * White blood cell count ≤ 13×10⁹/L before the first treatment with the study drug (hydroxyurea and leukapheresis are allowed). * Patients must be treatment-naïve to any systemic agents for CMML (e.g., azacitidine, decitabine,chemotherapy\<1 cycle, and the washout period should be more than 28 days, which is acceptable.), allogeneic stem cell transplant for CMML. Note: During screening and study participation, subjects may continue oral corticosteroids for diseases other than CMML (e.g. asthma) at a stable daily dose equivalent to ≤ 10 mg prednisone. In addition, supportive care in the form of blood transfusions or growth factors is not considered prior therapy in this case and is permitted prior to and as needed during the study. Exclusion Criteria: * Previous treatment with anti-CD47 monoclonal antibody/SIRPα fusion protein; * History of allogeneic stem cell transplant and other organ transplants; Patients who have undergone autologous haematopoietic stem cell transplant; * Prior diagnosis of: therapy-related Myelodysplastic syndrome / Myeloproliferative neoplasm(MDS/MPN); MDS evolved from a pre-existing Myelodysplastic syndrome / Myeloproliferative neoplasm (MDS/MPN) ;other MDS/MPN including atypical chronic myeloid leukemia (aCML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN. Patients positive for BCR-ABL fusion genes, PDGFRA, PDGFRB, and FGFR1 rearrangements need to be excluded; * Current or history of central nervous system (CNS) leukemia, extramedullary leukemia(excluding: Enlarged spleen, enlarged liver, enlarged lymph nodes), or myeloid sarcoma; * Diagnosis of other malignant neoplasms within 3 years prior to the first dose. Exceptions: a. Radically treated cervical carcinoma in situ or non-melanoma skin cancer,Surgery-cured prostate cancer and papillary thyroid cancer; b. a second primary cancer that has been curatively treated and has no recurrence within three years;

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Conditions

The condition(s) this trial relates to.

chronic myelomonocytic leukemia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic myelomonocytic leukemia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    43 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, China

  • Affiliated Hospital of Hebei University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • Affiliated Hospital of Xuzhou Medical University

    RECRUITING

    Xuzhou, Jiangsu, China

  • Anhui Provincial Hospital

    RECRUITING

    Hefei, Anhui, China

  • Changzhou First People's Hospital

    RECRUITING

    Changzhou, Jiangsu, China

  • China-Japan Friendship Hospita

    RECRUITING

    Beijing, Beijing Municipality, China

  • First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, Henan, China

  • First Hospital of Lanzhou University

    NOT_YET_RECRUITING

    Lanzhou, Gansu, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangzhou, China

  • Harbin First Hospital

    NOT_YET_RECRUITING

    Harbin, Heilongjiang, China

  • Henan Cancer Hospital

    RECRUITING

    Zhengzhou, Henan, China

  • Henan Provincial People's Hospital

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • Institute of Hematology and Blood Disease Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College;

    RECRUITING

    Tianjin, Tianjin Municipality, 300020, China

  • Jiangsu Province Hospital

    NOT_YET_RECRUITING

    Nanjing, Jiangsu, China

  • Jiangsu Subei People's Hospital

    RECRUITING

    Yangzhou, Jiangsu, China

  • Nanfang Hospital, Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, China

  • Ningbo First Hospital

    RECRUITING

    Ningbo, Zhejiang, China

  • Peking University People's Hospital

    NOT_YET_RECRUITING

    Beijing, China

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, China

  • Shaanxi Provincial People's Hospital

    RECRUITING

    Xi’an, Shanxi, China

  • Shengjing Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, China

  • Shenzhen Second People's Hospital

    NOT_YET_RECRUITING

    Shenzhen, Guangdong, China

  • Sichuan Provincial People's Hospital

    NOT_YET_RECRUITING

    Chengdu, Sichuan, China

  • The First Affiliated Hospital of Chongqing Medical University

    NOT_YET_RECRUITING

    Chongqing, Chongqing Municipality, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Gaungxi, China

  • The First Affiliated Hospital of Henan University of Science and Technology

    NOT_YET_RECRUITING

    Zhengzhou, Henan, China

  • The First Affiliated Hospital of Nanchang University

    NOT_YET_RECRUITING

    Nanchang, Jiangxi, China

  • The First Affiliated Hospital of Soochow University

    NOT_YET_RECRUITING

    Suzhou, Jiangsu, China

  • The First Affiliated Hospital of Wenzhou Medical University

    NOT_YET_RECRUITING

    Wenzhou, Zhejiang, China

  • The First Affiliated Hospital of Xinjiang Medical University

    RECRUITING

    Ürümqi, Xinjiang, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of China Medical University

    NOT_YET_RECRUITING

    Shenyang, Liaoning, China

  • The First Hospital of Jilin University

    RECRUITING

    Changchun, Jilin, China

  • The Second Affiliated Hospital of Kunming Medical University

    NOT_YET_RECRUITING

    Kunming, Yunnan, China

  • The Second Hospital of Hebei Medical University

    NOT_YET_RECRUITING

    Shijiazhuang, Hebei, China

  • Tianjin People's Hospital

    RECRUITING

    Tianjin, China

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

    RECRUITING

    Wuhan, Hubei, China

  • Xiangya Hospital Central South University

    NOT_YET_RECRUITING

    Changsha, Hunan, China

  • Xiangyang Central Hospital

    RECRUITING

    Xiangyang, Hubei, China

  • Yibin Second People's Hospital

    RECRUITING

    Yibin, Sichuan, China

  • Zhongda Hospital affiliated to Southeast University

    RECRUITING

    Nanjing, Jiangsu, China

  • Zhongnan Hospital Affiliated to Wuhan University

    NOT_YET_RECRUITING

    Wuhan, Hubei, China

  • Zhujiang Hospital of Southern Medical University

    NOT_YET_RECRUITING

    Zhujiang, Guangdong, China

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