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A Clinical Research of LeY-Targeted CAR-T in Myeloid Malignancies | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

A Clinical Research of LeY-Targeted CAR-T in Myeloid Malignancies

NCT02958384•Southwest Hospital, China

Summary

The overall purpose of this study is to explore the therapeutic effect of LeY-targeted chimeric antigen receptor T(CAR-T) cells in the treatment of myeloid malignancies.

Detailed Description

Lewis -Y（LeY） is a difucosylated carbohydrate antigen and although its function is not known, it is expressed on a wide range of malignancies including myeloid malignancies. LeY-targeted CAR-T in myeloid malignancies had been explored and showed good efficiency in the treatment of myeloid malignancies. This trial is designed and conducted to test the safety and effectiveness of LeY-targeted CAR-T.

Eligibility

Age

14 - 75 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. LeY-expressing myeloid malignancy must be assured and must be relapsed or refractory disease. According to current traditional therapies, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, or have disease activity that prohibits SCT at this time.
•2. Patients enrolled must have an evaluated score above 60 with KPS.
•3. LeY expression of the malignant cells must be detected by immunohistochemistry or by flow cytometry.
•4. Gender is not limited, age from 14 years to 75 years.
•5. Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis.
•6. Patients are expected to survive for more than 3 months by their physicians at the time of enrollment.
•7. Adequate absolute CD3 count estimated need to be assured for obtaining target cell dose based on dosage cohorts.
•8. Subjects with the following CNS status are eligible only in the absence of neurologic symptoms suggestive of CNS leukemia, such as cranial nerve palsy:
•14. Patients volunteer to participate in the research.

Exclusion Criteria

•9. Ability to give informed consent.
•10. Cardiac function: Left ventricular ejection fraction greater than or equal to 40% by MUGA or cardiac MRI, or fractional shortening greater than or equal to 28% by ECHO or left ventricular ejection fraction greater than or equal to 50% by ECHO.
•11. Renal function: Creatinine level of peripheral blood is required no greater than 133umol/L.
•12. Females of child-bearing potential must have a negative pregnancy test because of the potentially dangerous effects on the fetus.
•1. Evident signs suggesting that patients are potentially allergic to cytokines.
•2. Frequent infection history and recent infection is uncontrolled.
•3. Patients with concomitant genetic syndrome: patients with Down syndrome, Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome
•4. Active acute or chronic graft-versus-host disease (GVHD) or requirement of immunosuppressant medications for GVHD within 4 weeks of enrollment.
•5. Concurrent use of systemic steroids or chronic use of immunosuppressant medications. Recent or current use of inhaled steroids is not exclusionary. For additional details regarding use of steroid and immunosuppressant medications.
•6. Pregnancy and nursing females.
+5 more criteria

Locations (1)

Southwest Hospital of Third Millitary Medical University

Chongqing, Chongqing Municipality, China

Key Dates

Start Date

October 1, 2016

Primary Completion Date

October 1, 2019

Completion Date

October 1, 2020

Last Updated

January 23, 2018

Enrollment

ESTIMATED participants

Conditions

Myeloid Malignancies

Interventions

Anti-LeY-CAR-transduced T cells

BIOLOGICAL

Contacts

Cheng Qian, MD, PhD

CONTACT

0086-023-68765461 cqian3184@163.com

Shiqi Li, MD

CONTACT

0086-13206140093 Lystch@qq.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 23, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Clinical Research of LeY-Targeted CAR-T in Myeloid Malignancies

Inclusion Criteria

Exclusion Criteria

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