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NCT05140811 | Recruiting | Acute Myeloid Leukemia

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

ImmuneOnco Biopharmaceuticals (Shanghai) Inc.

Brief 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).

Condition or disease

Acute Myeloid Leukemia

Myelodysplastic Syndromes

Intervention/treatment

IMM01

Azacitidine

Phase

Phase 1

Phase 2

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.}}

Study Type : Interventional
Estimated Enrollment : 126 participants
Masking : None (Open Label)
Primary Purpose : Treatment
Official Title : Phase 1/Phase 2 Study of IMM01 Combined With Azacitidine in Patients With AML and MDS
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : February 5, 2024
Estimated Study Completion Date : March 1, 2024
Arm Intervention/treatment

Experimental: Relapse/Refractory AML

IMM01 and Azacitidine in Relapse/Refractory AML Interventions: Drug: IMM01 Drug: Azacitidine

Drug: IMM01

Drug: Azacitidine

Experimental: Relapsed or Refractory MDS

IMM01 and Azacitidine in Relapse/Refractory MDS Interventions: Drug: IMM01 Drug: Azacitidine

Drug: IMM01

Drug: Azacitidine

Experimental: Treatment naive AML

IMM01 and Azacitidine in treatment naive AML Interventions: Drug: IMM01 Drug: Azacitidine

Drug: IMM01

Drug: Azacitidine

Experimental: Treatment naive MDS and naive CMML

IMM01 and Azacitidine in treatment naive MDS and naive CMML Interventions: Drug: IMM01 Drug: Azacitidine

Drug: IMM01

Drug: Azacitidine
Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • 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).
  • 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.
Exclusion Criteria
  • 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;
    • 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.
A Study of IMM01 Combined With Azacitidine in Patients With Acute Myeloid Leukemia and Myelodysplastic Syndrome

Location Details

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

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

Recruiting

China,

Beijing gobroad boren hospital

Beijing, China,

Not yet recruiting

China,

Peking university third hospital

Beijing, China,

Recruiting

China,

Xuanwu Hospital, Capital Medical University

Beijing, China,

Recruiting

China,

Chongqing university cancer hospital

Chongqing, China,

Recruiting

China,

Second Affiliated Hospital of Army Medical University

Chongqing, China,

Recruiting

China,

Fujian medical university union hospital

F U axis, China,

Recruiting

China,

Ganzhou People's Hospital

Ganzhou, China,

Recruiting

China,

Guangdong provincial people hospital

Guangzhou, China,

Recruiting

China,

Nanfang Hospital, Southern Medical University

Guangzhou, China,

Recruiting

China,

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

Guangzhou, China,

Recruiting

China,

The first affiliated hospital zhejiang university school of medicine

Hangzhou, China,

Recruiting

China,

The first affiliated hospital of nanchang University

Nanchang, China,

Recruiting

China,

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China,

Recruiting

China,

Shanghai sixth's hospital

Shanghai, China,

Recruiting

China,

Tongren hospital shanghai jiaotong university school of medicine

Shanghai, China,

Recruiting

China,

Shengjing Hospital Affiliated to China Medical University

Shenyang, China,

Recruiting

China,

The First Hospital of China Medical University

Shenyang, China,

Recruiting

China,

Tianjin Blood Disease Hospital

Tianjin, China,

Recruiting

China,

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China,

Recruiting

China,

The affiliated hospital of Xuzhou medical university

Xuzhou, China,

Recruiting

China,

Henan Cancer Hospital

Zhengzhou, China,

Recruiting

China,

The first affiliated hospital of Zhengzhou University

Zhengzhou, China,