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Relapsed/Refractory Acute Myeloid Leukemia(AML)AMLNCT03473457

CAR-T Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia

A study testing CART therapy in Acute myeloid leukemia(AML) in people with Relapsed/Refractory Acute Myeloid Leukemia(AML), run by Zhujiang Hospital at 1 site in China.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. Read more about this study

Who is it for?
Ages 6 months and older
What is being tested?
CART therapy in Acute myeloid leukemia(AML)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2 participants
Where
1 siteChina
Study dates
1 Apr 2018to 31 Dec 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 months and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Relapsed/Refractory AML patients
  • Positive for any of CD33, CD38, CD56, CD117, CD123, CD34, or Muc1.(cytology, genetic testing)
  • Estimated survival time is more than 3 months in multiple myeloma,and Karnofsky Performance Status（KPS) score is more than 80.
  • No cytapheresis and cell separation contraindication.
  • Hemoglobin is more than 80 gram per litre.
  • The function of important organ was satisfied:(1)cardiac ultrasound indicated that cardiac ejection fractions is more than 50%（EF≥50%）, and the electrocardiogram showed no obvious abnormality;(2)Blood oxygen saturation is more than 90%（SpO2≥90%）;(3)Creatinine（Cr） is less than 2.5 times the upper limit of normal;(4)Alanine transaminase（ALT）and glutamic-oxalacetic transaminase（AST）is less than 3 times the upper limit of normal,and total bilirubin is less than 2 milligram per deciliter(TBil≤2.0mg/dL).
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  • After discussion by the expert group, the patient's condition was analyzed and combined with the general physical condition of the patient, the benefit of participating in the clinical trial was greater than the risk.
  • Volunteered for this clinical trail and signed a consent form .
  • Currently, chemotherapy and approved targeted therapies are ineffective for the patients.Or patients cannot tolerate current chemotherapy.

Who cannot join

  • Active other disease and cannot control after treatment.
  • Patients with actively infection of Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV).
  • Severe psychiatric disorder or other disease in central nervous system.
  • Patients are infected with fungus,bacteria or virus,and are difficult to control after treatment.
  • Patients with infection of HIV .
  • Pregnant or lactating women.
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  • Patients who have Graft-Versus-Host Disease (GVHD) should receive systemic administration of immunosuppressive agents.
  • Patients have received other genetic therapy products.
  • Patients who have received systemic administration of glucocorticoid agents in one week before CART therapy.
  • Any situation may do harm to the subjects or interfere the results.
  • Have had Prolonged QT interval or severe heart disease in the past.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Southern Medical University Zhujiang Hospital

    Guangdong, Guangdong, 510000

Other trials in China

About this study

Official title: The Prospective, Multi-center And Single-arm Clinical Study of Chimeric Antigen Receptor T(CAR-T) Cells Therapy in Relapsed/Refractory Acute Myeloid Leukemia

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease . The disease is the most common type of adult acute leukemia. Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy. The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, although it start late, several clinical trials have been register in ClinicalTrials.gov.

Read the detailed description

Acute myeloid leukemia (AML) is a group of genetically highly heterogeneous malignant disease ,its' character is immature myeloid protocel abnormal differentiation and proliferation in the bone marrow. The disease is the most common type of adult acute leukemia, Overall survival (OS) was less than 50% in 5 years. Chimeric Antigen Receptor-transduced T cell (CAR-T) therapy is one of revolutionary targeted immunotherapy.

CAR - T cells are taken in the form of genetic modification, and specific identified target antigen monoclonal antibody of single variable region (scFv) expression in T cell surface, and coupled with the activation of intracellular proliferation signal domain.When scFv recognizes antigens expressed in malignant cells, it stimulates the activation signal of downstream T cells and produces specific killing effects. CAR-T therapy is one of revolutionary targeted immunotherapy.The efficacy of CAR-T cells for the treatment of acute B lymphocytic leukemia has been widely recognized, although it start late, several clinical trials have been register in ClinicalTrials.gov.

The cluster of differentiation (CD) antigen serves as the target for identification and research in the immuno-phenotype detection of cells.As the surface markers of immune typing, CD molecules can be used as cell identification for expression types and levels on the cell surface.Cell surface of AML has a specific type of CD molecule expression,such as cluster of differentiation antigen 33(CD33),cluster of differentiation 38(CD38),cluster of differentiation 56 (CD56), cluster of differentiation 123(CD123), cluster of differentiation 117(CD117), cluster of differentiation 133(CD133), cluster of differentiation 34(CD34) and Mucl.Therefore, it provides some good targets for the immunotherapy of CAR T cells.In AML cells and mouse model,some studies have confirmed anti-CD33 CAR-T and anti-CD123 CAR-T with good similar lethality, but the toxicity of CAR-T to myeloid hematopoietic stem/progenitor cells and mononuclear cells is widespread.In comparison,CD123 CAR-T Off-target effects slighter than CD33 CAR-T.

In order to lay a foundation for the application of relapsed/refractory AML patients with CAR-T therapy，objects are refractory/ relapsed patients with AML,and plans to into the group of the number of cases in 50 cases.The main content is safety, efficacy and feasibility analysis of the CAR-T cells （single CAR-T or double CAR-T cells with CD33,CD38,CD56,CD123,CD117,CD133,CD34 or Mucl ) in the treatment of refractory/relapsed AML.

Being tested
CART therapy in Acute myeloid leukemia(AML)
Keywords
CD38-CART, CD33-CART, CD56-CART, CD123-CART, CD117-CART, CD133-CART, CD34-CART, Mucl-CART
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CART therapy in Acute myeloid leukemia(AML)Biological

    one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART therapy in Acute myeloid leukemia(AML)

Study groups in NCT03473457
Study groupRoleWhat they receive
CART therapy in Acute myeloid leukemiaExperimentalIn order to assess the safety and validity of using CAR-T therapy refractory/relapsed acute myeloid leukemia（AML）patients with one kind of CD38-CART/CD33-CART/CD56-CART/CD123-CART/CD117-CART/CD133-CART/CD34-CART/Mucl-CART,subjects will receive 10^6-10^7/Kg transduced CAR T cells at one time.
Receives: Biological: CART therapy in Acute myeloid leukemia(AML)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adverse events that Are related to treatment

    Determine the toxicity profile of the CD38/CD33/CD56/CD123/CD117/CD133/CD34/ Mucl-targeted CAR-T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0

    Measured: 2 years

Secondary outcomes (3)

  1. Estimate 2 year overall survival(OS) after infusion of CD38/CD33/CD56/CD123/ CD117/CD133/CD34/Mucl-CART and sequential treatment

    To estimate 2 year overall survival(OS) after CD38/CD33/CD56/CD123/CD117/CD133/ CD34/Mucl-CART infusion and sequential treatment with Relapsed/Refractory AML

    Measured: 2 years

  2. Estimate 2 year relapse rate after infusion of CD38/CD33/CD56/CD123/CD117/CD133/ CD34/Mucl-CART and sequential treatment

    To estimate 2 year relapse rate after CD38/CD33/CD56/CD123/CD117/CD133/CD34/ Mucl-CART infusion and sequential treatment with Relapsed/Refractory AML

    Measured: 2 years

  3. Estimate 2 year progression free survival after CD117/CD133/CD34/ Mucl-CART and sequential treatment

    To estimate 2 year progression free survival after CD38/CD33/CD56/CD123/CD117/ CD133/CD34/Mucl-CART infusion and sequential treatment with Relapsed/Refractory AML

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Mar 2018
  2. Study start1 Apr 2018
  3. Primary completion31 Dec 2020
  4. Study completion31 Dec 2020

Why it stopped: The therapeutic effect was not as expected

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
2 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03473457
Sponsor's protocol ID
2017-XYNK-002
Acronym
AML
Status last verified
Sep 2021
First submitted
15 Mar 2018
Last updated
13 Sep 2021
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A study testing CART therapy in Acute myeloid leukemia(AML) in people with Relapsed/Refractory Acute Myeloid Leukemia(AML), run by Zhujiang Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: The therapeutic effect was not as expected). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Adverse events that Are related to treatment (time frame: 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03473457.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.

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