Under construction – not a live service
Sign in
Not yet taking people in ChinaEarly phase 1

Tests IL3 CAR-T cell therapy in people with CD123-positive acute myeloid leukemia

Tests IL3 CAR-T cells in people with relapsed or resistant leukemia.

Key facts

Who runs it
Zhejiang University
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia
Status
Not yet recruiting
Phase
Early phase 1
People taking part
36 people, planned
Started
15 Nov 2020
Expected to end
15 Nov 2026
Type of study
Interventional
Treatments tested
  • IL3 CAR T-cells
Record updated
27 October 2020

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for people with acute myeloid leukemia (AML) whose cancer cells carry the CD123 marker and whose disease has come back or did not respond to treatment.

Sex
All sexes can join.
Disease stage
CD123-positive AML that has relapsed or did not respond to treatment. Examples: no remission after standard chemotherapy, remission lasting under 12 months, or 2 or more relapses. Bone marrow must show more than 5% primordial cells (by morphology) and/or more than 0.01% (by flow cytometry).
Earlier treatment
Must have had standard chemotherapy or other treatments that did not work. Must not have had any CAR-T cell product or other gene-modified T cell therapy.
Biomarker or test result
CD123-positive AML (CD123+), confirmed by tissue testing.

Main reasons for not taking part

  • Pregnant or breastfeeding women
  • Severe active infection, or active hepatitis B or hepatitis C
  • HIV infection
  • Past brain injury, epilepsy, or stroke or bleeding in the brain; or serious heart rhythm problems or heart disease
  • Steroid treatment through the body within 2 weeks before screening

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases
  • Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis)
  • Active infection of hepatitis B virus or hepatitis C virus
  • Other uncontrolled diseases that were not suitable for this trial
  • Patients with HIV infection
  • Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past
  • Creatinine>2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl
  • Subjects with any of the following exclusion criteria were not eligible for this trial:
  • Pregnant (or lactating) women
  • Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study

Where in China

  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaContact: He Huang, PhDNo longer taking part

About the trial

What the trial wants to find out

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

The group in the trial

  • Administration of IL3 CAR T-cellsTreatment being tested

    Treatment: IL3 CAR T-cells

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Tests IL3 CAR-T cell therapy in people with CD123-positive acute myeloid leukemiaGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
27 October 2020