Description:
A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory
Acute Myeloid Leukemia.
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
Interventions
Drug | Synonyms | Arms |
---|
IL3 CAR T-cells | IL3 CAR-T cells injection | Administration 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
Name | Type | Description | Interventions |
---|
Administration of IL3 CAR T-cells | Experimental | | |
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 27, 2020