Clinical Trials /

IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia

NCT04599543

Description:

A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia.

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Not yet recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia
  • Official Title: Clinical Trial for the Safety and Efficacy of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia

Clinical Trial IDs

  • ORG STUDY ID: CD123-001
  • NCT ID: NCT04599543

Conditions

  • Acute Myeloid Leukemia

Interventions

DrugSynonymsArms
IL3 CAR T-cellsIL3 CAR-T cells injectionAdministration of IL3 CAR T-cells

Purpose

A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia.

Detailed Description

      This is a single arm, open-label, single-center study. This study is indicated for relapsed
      or refractory CD123+ acute myeloid leukemia. The selections of dose levels and the number of
      subjects are based on clinical trials of similar foreign products. 36 patients will be
      enrolled. Primary objective is to explore the safety, main consideration is dose-related
      safety.
    

Trial Arms

NameTypeDescriptionInterventions
Administration of IL3 CAR T-cellsExperimental
  • IL3 CAR T-cells

Eligibility Criteria

        Inclusion Criteria:

          1. Histologically confirmed diagnosis of CD123+ AML per the US National Comprehensive
             Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia
             (2016.v1);

          2. Relapsed or refractory CD123+ AML (meeting one of the following conditions):

               1. CR not achieved after standardized chemotherapy;

               2. CR achieved following the first induction, but CR duration is less than 12
                  months;

               3. Ineffectively after first or multiple remedial treatments;

               4. 2 or more relapses;

          3. The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01%
             (by flowcytometry);

          4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine
             ≤ 176.8 umol/L;

          5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;

          6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;

          7. Estimated survival time ≥ 3 months;

          8. ECOG performance status 0 to 2;

          9. Patients or their legal guardians volunteer to participate in the studyand sign the
             informed consent.

        Exclusion Criteria:

        Subjects with any of the following exclusion criteria were not eligible for this trial:

          1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular
             ischemia, and cerebrovascular, hemorrhagicdiseases;

          2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe
             arrhythmia in the past;

          3. Pregnant (or lactating) women;

          4. Patients with severe active infections (excluding simple urinarytractinfectionand
             bacterial pharyngitis);

          5. Active infection of hepatitis B virus or hepatitis C virus;

          6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for
             the patients recently or currently receiving in haledsteroids;

          7. Previously treated with any CAR-T cell product or other genetically-modified T cell
             therapies;

          8. Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;

          9. Other uncontrolled diseases that were not suitable for this trial;

         10. Patients with HIV infection;

         11. Any situations that the investigator believes may increase the risk ofpatients or
             interfere with the results of study.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:N/A
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Dose-limiting toxicity (DLT)
Time Frame:Baseline up to 28 days after IL3 targeted CAR T-cells infusion
Safety Issue:
Description:Adverse events assessed according to NCI-CTCAE v5.0 criteria

Secondary Outcome Measures

Measure:Acute Myeloid Leukemia (AML), Overall response rate (ORR)
Time Frame:At Month 1, 3, 6, 12, 18 and 24
Safety Issue:
Description:Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24
Measure:AML, Overall survival (OS)
Time Frame:Up to 2 years after IL3 CAR-T cells infusion
Safety Issue:
Description:From the first infusion of IL3 CAR-T cells to death or the last visit
Measure:AML, Event-free survival (EFS)
Time Frame:Up to 2 years after IL3 CAR-T cells infusion
Safety Issue:
Description:From the first infusion of IL3 CAR-T cells to the occurrence of any event, including death, relapse or generelapse, disease progression (any one occurs first), and the last visit
Measure:Quality of life
Time Frame:At Baseline, Month 1, 3, 6, 9 and 12
Safety Issue:
Description:Assessment using European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) scale [For item1-28: max score: 112, min score: 28, higher scores mean a better outcome; for item 28-29: max score: 14, min score: 2, higher scores mean a worse outcome] to measure Quality of life at Baseline, Month 1, 3, 6, 9 and 12
Measure:Activities of Daily Living (ADL) score
Time Frame:At Baseline, Month 1, 3, 6, 9 and 12
Safety Issue:
Description:Assessment using Activities of Daily Living (ADL) scale (Barthel Index) [max score: 100, min score: 0, higher scores mean a better outcome] at Baseline, Month 1, 3, 6, 9 and 12
Measure:Instrumental Activities of Daily Living (IADL) score
Time Frame:At Baseline, Month 1, 3, 6, 9 and 12
Safety Issue:
Description:Assessment of Instrumental Activities of Daily Living (IADL) scale [max score: 56, min score: 14, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12
Measure:Hospital Anxiety and Depression Scale (HADS) score
Time Frame:At Baseline, Month 1, 3, 6, 9 and 12
Safety Issue:
Description:Assessment using Hospital Anxiety and Depression Scale (HADS) [max score: 42, min score: 0, higher scores mean a worse outcome] at Baseline, Month 1, 3, 6, 9 and 12

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Zhejiang University

Trial Keywords

  • Acute Myeloid Leukemia
  • CAR T-cell therapy
  • CD123

Last Updated

October 22, 2020