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

NCT05140811 | Unknown Phase 1

• 1 other identifier: IMM01-02
• Study Type: interventional
• Target: 126
• Locations: 1 country
• Sites: 22

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).

Conditions

Acute Myeloid Leukemia; Myelodysplastic Syndromes

Outcome Measures

Primary Outcomes (2)

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

  To be summarized using descriptive statistics

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

• 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.

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

Secondary Outcomes (6)

• Pharmacokinetics - Cmax

  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).

• Pharmacokinetics - AUC

  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).

• Pharmacokinetics - tmax

  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).

• Pharmacokinetics - T1/2

  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).

• Response Rate

  When the last subject enrolled completes approximately 12 months of treatment

Other Outcomes (1)

• Exploratory Endpoint

  In cycle 1(each cycle is 28 days) and cycle 4, 6, 8, 10, and 12, at the end of treatment or early study withdrawal, and 30 days after the last dose.

Study Arms (4)

Relapse/Refractory AML

EXPERIMENTAL

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

Drug: IMM01; Drug: Azacitidine

Relapsed or Refractory MDS

EXPERIMENTAL

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

Drug: IMM01; Drug: Azacitidine

Treatment naive AML

EXPERIMENTAL

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

Drug: IMM01; Drug: Azacitidine

Treatment naive MDS and naive CMML

EXPERIMENTAL

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

Drug: IMM01; Drug: Azacitidine

Interventions

IMM01 DRUG

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

Also known as: IMM01 Ingection

Relapse/Refractory AML; Relapsed or Refractory MDS; Treatment naive AML; Treatment naive MDS and naive CMML

Azacitidine DRUG

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

Also known as: Vidaza

Relapse/Refractory AML; Relapsed or Refractory MDS; Treatment naive AML; Treatment naive MDS and naive CMML

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• ImmuneOnco Biopharmaceuticals (Shanghai) Inc.: lead
• Institute of Hematology & Blood Diseases Hospital, China: collaborator

Study Sites (22)

Beijing gobroad boren hospital

Beijing, China

RECRUITING

Peking university third hospital

Beijing, China

NOT YET RECRUITING

Xuanwu Hospital, Capital Medical University

Beijing, China

RECRUITING

Chongqing university cancer hospital

Chongqing, China

RECRUITING

Second Affliated Hospital of Army Medical University

Chongqing, China

RECRUITING

Fujian medical university union hospital

Fuzhou, China

RECRUITING

Ganzhou People's Hospital

Ganzhou, China

RECRUITING

Guangdong provincial people hospital

Guangzhou, China

RECRUITING

Nanfang Hospital, Southern Medical University

Guangzhou, China

RECRUITING

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

Guangzhou, China

RECRUITING

The first affiliated hospital zhejiang university school of medicine

Hangzhou, China

RECRUITING

The first affiliated hospital of nanchang University

Nanchang, China

RECRUITING

Ruijin Hospital, Shanghai Jiaotong University School of Medicine

Shanghai, China

RECRUITING

Shanghai sixth's hospital

Shanghai, China

RECRUITING

Tongren hospital shanghai jiaotong university school of medicine

Shanghai, China

RECRUITING

Shengjing Hospital Affiliated to China Medical University

Shenyang, China

RECRUITING

The First Hospital of China Medical University

Shenyang, China

RECRUITING

Tianjin Blood Disease Hospital

Tianjin, China

RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

RECRUITING

The affiliated hospital of Xuzhou medical university

Xuzhou, China

RECRUITING

Henan Cancer Hospital

Zhengzhou, China

RECRUITING

The first affiliated hospital of Zhengzhou University

Zhengzhou, China

RECRUITING

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Myelodysplastic Syndromes

Interventions

Azacitidine

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Aza Compounds; Organic Chemicals; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Central Study Contacts

jinhua zhou

CONTACT

02138016387; jinhua.zhou@immuneonco.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2021
• First Posted: December 1, 2021
• Study Start: January 5, 2022
• Primary Completion: February 5, 2024
• Study Completion: March 1, 2024
• Last Updated: May 24, 2023

Record last verified: 2023-05

Locations

CN (22)