Clinical Trials /

A Phase I/IIa Clinical Research of TJ011133 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (r/r AML)

NCT04202003

Description:

A multi-center, open, single-arm, Phase I/IIa clinical research to evaluate the safety, tolerance, pharmacokinetics, pharmacodynamics and preliminary efficacy of TJ011133 in the treatment of patients with relapsed or refractory acute myeloid leukemia (r/r AML)

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase I/IIa Clinical Research of TJ011133 in Patients With Relapsed or Refractory Acute Myeloid Leukemia (r/r AML)
  • Official Title: A Multi-center, Open, Single-arm, Phase I/IIa Clinical Research to Evaluate the Safety, Tolerance, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of TJ011133 in the Treatment of Patients With Relapsed or Refractory Acute Myeloid Leukemia (r/r AML)

Clinical Trial IDs

  • ORG STUDY ID: TJ011133AML102
  • NCT ID: NCT04202003

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
TJ011133TJ011133

Purpose

A multi-center, open, single-arm, Phase I/IIa clinical research to evaluate the safety, tolerance, pharmacokinetics, pharmacodynamics and preliminary efficacy of TJ011133 in the treatment of patients with relapsed or refractory acute myeloid leukemia (r/r AML)

Trial Arms

NameTypeDescriptionInterventions
TJ011133ExperimentalTJ011133 is tentatively administered once a week for a treatment cycle every 28 days
  • TJ011133

Eligibility Criteria

        Inclusion Criteria:

          -  Subjects must be ≥18 and ≤70 years old when signing the informed consent, with no
             limitation of gender;

          -  Subjects must be patients with pathologically confirmed acute myeloid leukemia (AML)
             and complying with the World Health Organization (WHO) criteria for classification,
             excluding those with acute promyelocytic leukemia;

          -  Subjects must be patients with recurrent or refractory *AML with no further
             appropriate routine therapy;

          -  Subjects must be willing to provide available diagnostic evidence prior to treatment
             or undergo bone marrow aspiration and biopsy, and willing to undergo marrow aspiration
             and biopsy after accepting research and treatment.

          -  Eastern Cooperative Oncology Group(ECOG) score is 0 - 2;

          -  Expected survival ≥12 weeks;

          -  White blood cell count (WBC) is ≤ 25 x103/µL within 7 days before the first
             administration (hydroxyurea or leukocyte depletion is allowed to meet this standard);

          -  Subjects have been recovered from the toxicity of previous anti-leukemia treatments
             (according to NCI Common Terminology Criteria for Adverse Events (CTC AE) 5.0 ≤ 1
             level, except hair loss);

          -  Subjects must have full liver function, renal function and coagulation function. The
             laboratory tests within 7 days before the first administration should meet the
             following requirements:

          -  Subjects must give informed consent before the test and sign written consent
             voluntarily by themselves (or their legal representatives). Subjects or their legal
             representatives should be able to communicate well with investigators and agree to
             complete the test according to the scheme.

        Exclusion Criteria:

          -  Subjects must be excluded if meeting any of the following criteria:

          -  Subjects have previously received treatment with other drugs targeting CD47;

          -  Subjects have previously received Chimeric Antigen Receptor T-Cell (CAR-T ) therapy;

          -  Subjects have previously received treatment with PD1 or PDL1 antibodies;

          -  Subjects have previously received allogenic stem cell transplant, or received
             autologous stem cell transplant within 3 months before administration of the research
             drug;

          -  Subjects have received chemotherapy, immunotherapy, radiotherapy and large-scale
             surgery within 4 weeks before the first administration;

          -  Subjects have received the vaccine within 4 weeks before the first administration
             and/or after planing to participate in the trial;

          -  Subjects have received clinical trial medication within four weeks before first
             administration or are participating in other interventional clinical trials;

          -  Subjects are known to have hereditary or acquired hemorrhagic diseases;

          -  Subjects meet any of the following cardiac function criteria:

          -  Subjects have hypertension unable to be well controlled by medication (systolic blood
             pressure ≥140mmHg or diastolic blood pressure≥90mmHg in resting state);

          -  Subjects suffer from diseases requiring long-term treatment with systemic steroids or
             other immunosuppressive agents. However, patients who use physiologically alternative
             doses of hydrocortisone or its equivalent dose (Annex 6) may be considered for
             enrollment: hydrocortisone up to 20mg (or 5 mg of pernisin) in the morning, and
             hydrocortisone up to 10mg (or 2.5 mg of pernisin) at night;

          -  Subjects are known to have central nervous system (CNS) attacks;

          -  Subjects are known to have HIV infection (anti-HIV positive), active hepatitis B
             (HBsAg positive, or HBcAb positive and HBV-DNA PCR positive), or active hepatitis C
             (anti-HCV positive and HCV-RNA PCR positive), or syphilis (anti-TP positive);

          -  Subjects have a history of solid organ transplantation;

          -  Subjects are receiving other antineoplastic treatments, including but not limited to
             chemotherapy, biotherapy, immunotherapy, hormone therapy and treatment by Chinese
             herbs while planning to participate in the trial;

          -  Subjects have a history of autoimmune diseases or active autoimmune diseases;

          -  Subjects still have uncontrolled active infections;

          -  Subjects have severe electrolyte disorders that cannot be corrected;

          -  Subjects have a history of other malignant tumors, except for clinically cured
             malignant tumors (relapse free for at least 5 years), cured in situ cancers and skin
             cancers of non-malignant melanoma;

          -  Subjects have a history of psychotropic drug abuse and are unable to quit or have
             mental disorders, or are judged be the investigators to have concomitant diseases that
             seriously endanger patients' safety or hinder the patients from completion of the
             test;

          -  Subjects are women during pregnancy or lactation, or women and men with fertility
             planning;

          -  The investigators believe that patients have other factors that may affect the results
             of the research and interfere with their full participation in the research, including
             previous or existing health conditions or abnormal medical or laboratory examination,
             or put them at high risk
      
Maximum Eligible Age:70 Years
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose Limiting Toxicities(DLT)
Time Frame:28days after first dose
Safety Issue:
Description:To evaluate the safety and tolerance of TJ011133 monotherapy in patients with r/r AML

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:I-Mab Biopharma HongKong Limited

Last Updated

December 15, 2019