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Not yet taking people in ChinaEarly phase 1

Tests modified immune cells in people with relapsed or hard-to-treat leukemia

Tests modified immune cells in people with acute myeloid leukemia that returned.

Key facts

Who runs it
Zhejiang University
Where
Hangzhou, ChinaSee the site
Trial code
Registry title
NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Status
Not yet recruiting
Phase
Early phase 1
People taking part
36 people, planned
Started
15 Jan 2021
Expected to end
15 Jan 2027
Type of study
Interventional
Treatments tested
  • NKG2D CAR T-cells
Record updated
8 December 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) that has come back or did not respond to treatment, and whose leukemia cells are NKG2D ligand positive.

Age
From 3 Years to 70 Years.
Sex
All sexes can join.
Disease stage
NKG2D ligand positive AML that relapsed or is refractory: no complete remission after standard chemotherapy, remission lasting less than 12 months after first induction, no response after first or repeated treatments, or 2 or more relapses. Primordial cells in bone marrow > 5% (by morphology) and/or > 0.01% (by flow cytometry).
Earlier treatment
Must have had standard chemotherapy. Cannot have had any CAR-T cell product or other genetically modified T cell therapy. Cannot have had systemic steroids within 2 weeks before screening.
Biomarker or test result
NKG2D ligand positive AML. LVEF ≥50% on echocardiogram. Blood oxygen saturation in room air ≥ 92%.

Main reasons for not taking part

  • History of head injury, epilepsy, stroke or brain bleeding
  • Prolonged QT interval or severe heart disease such as severe arrhythmia
  • Pregnant or breastfeeding women
  • Severe active infection, or active hepatitis B or hepatitis C
  • HIV infection

The registry criteria, word for word

Show all 21 criteriaShow less

Who can take part

  • Histologically confirmed diagnosis of NKG2D ligand positive AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1)
  • Relapsed or refractory NKG2D ligand positive 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 flow cyto metry)
  • Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit of normal, creatinine ≤ 176.8 umol/L
  • Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%
  • No active infection in the lungs, blood oxygen saturation in indoor air is ≥ 92%
  • Estimated survival time ≥ 3 months
  • ECOG performance status 0 to 2
  • Patients or their legal guardians volunteer to participate in the study and sign the informed consent

Who cannot take part

  • Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids
  • 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, hemorrhagic diseases
  • Patients with severe active infections (excluding simple urinary tract infection and 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 diseases such 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 of patients or interfere with the results of study

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 3 and 70 years old?

Where in China

  • The First Affiliated Hospital, College of Medicine, Zhejiang UniversityHangzhou, ChinaContact: He Huang, PhDNot yet recruiting

About the trial

What the trial wants to find out

A Study of NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia.

The group in the trial

  • Administration of NKG2D CAR T-cellsTreatment being tested

    Treatment: NKG2D 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 NKG2D CAR-T Cell Therapy for Patients With Relapsed and/or Refractory Acute Myeloid Leukemia
Plain-language title
Tests modified immune cells in people with relapsed or hard-to-treat 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.
Fit questions
Built from NCT04658004, who can take part
Record updated
8 December 2020