- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04599543
IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia
October 22, 2020 updated by: He Huang, Zhejiang University
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
A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
36
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Zhejiang
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Hangzhou, Zhejiang, China, 310003
- The First Affiliated Hospital,College of Medicine, Zhejiang University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Histologically confirmed diagnosis of CD123+ AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
Relapsed or refractory CD123+ AML (meeting one of the following conditions):
- CR not achieved after standardized chemotherapy;
- CR achieved following the first induction, but CR duration is less than 12 months;
- Ineffectively after first or multiple remedial treatments;
- 2 or more relapses;
- The number of primordial cells in bone marrow is > 5% (by morphology), and/or > 0.01% (by flowcytometry);
- Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
- Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
- No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
- Estimated survival time ≥ 3 months;
- ECOG performance status 0 to 2;
- 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:
- History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Administration of IL3 CAR T-cells
|
Each subject receive IL3 CAR T-cells by intravenous infusion
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Dose-limiting toxicity (DLT)
Time Frame: Baseline up to 28 days after IL3 targeted CAR T-cells infusion
|
Adverse events assessed according to NCI-CTCAE v5.0 criteria
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Baseline up to 28 days after IL3 targeted CAR T-cells infusion
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Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Up to 2 years after IL3 targeted CAR T-cells infusion
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Incidence of treatment-emergent adverse events [Safety and Tolerability]
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Up to 2 years after IL3 targeted CAR T-cells infusion
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Activities of Daily Living (ADL) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
|
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
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At Baseline, Month 1, 3, 6, 9 and 12
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Instrumental Activities of Daily Living (IADL) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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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
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At Baseline, Month 1, 3, 6, 9 and 12
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Hospital Anxiety and Depression Scale (HADS) score
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
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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
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At Baseline, Month 1, 3, 6, 9 and 12
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Quality of life
Time Frame: At Baseline, Month 1, 3, 6, 9 and 12
|
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
|
At Baseline, Month 1, 3, 6, 9 and 12
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Acute Myeloid Leukemia (AML), Overall response rate (ORR)
Time Frame: At Month 1, 3, 6, 12, 18 and 24
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Assessment of ORR (ORR = CR + CRi) at Month 6, 12, 18 and 24
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At Month 1, 3, 6, 12, 18 and 24
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AML, Overall survival (OS)
Time Frame: Up to 2 years after IL3 CAR-T cells infusion
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From the first infusion of IL3 CAR-T cells to death or the last visit
|
Up to 2 years after IL3 CAR-T cells infusion
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AML, Event-free survival (EFS)
Time Frame: Up to 2 years after IL3 CAR-T cells infusion
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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
|
Up to 2 years after IL3 CAR-T cells infusion
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ANTICIPATED)
November 15, 2020
Primary Completion (ANTICIPATED)
November 15, 2023
Study Completion (ANTICIPATED)
November 15, 2026
Study Registration Dates
First Submitted
October 21, 2020
First Submitted That Met QC Criteria
October 21, 2020
First Posted (ACTUAL)
October 22, 2020
Study Record Updates
Last Update Posted (ACTUAL)
October 27, 2020
Last Update Submitted That Met QC Criteria
October 22, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CD123-001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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