Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With Acute Lymphoblastic Leukemia
NCT ID: NCT02186860
Last Updated: 2021-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1
5 participants
INTERVENTIONAL
2016-07-31
2021-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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CAR-T cells
Targeting CD19
CAR-T cells
Given IV
Interventions
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CAR-T cells
Given IV
Eligibility Criteria
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Inclusion Criteria
* Patients with Cluster of Differentiation 19 (CD19) positive B cell malignancies as confirmed by flow cytometry
* Refractory or relapsed B cell-acute lymphoblastic leukemia
* No available curative treatment options (such as hematopoietic stem cell transplantation)
* Stage III-IV disease
* Creatinine \< 2.5 mg/dl
* Aspartate transaminase-alanine transaminase ratio \< 3x normal
* Bilirubin \< 2.0 mg/dl
* Karnofsky performance status \>= 60
* Expected survival time \> 3 months
* Adequate venous access for apheresis
* Ability to understand and provide informed consent
Exclusion Criteria
* Patients requiring T cell immunosuppressive therapy
* Active central nervous system leukemia
* Any concurrent active malignancies
* Patients with a history of a seizure disorder or cardiac disorder
* Patients with human immunodeficiency virus, hepatitis B or C infection
* Uncontrolled active infection
18 Years
65 Years
ALL
No
Sponsors
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Affiliated Hospital to Academy of Military Medical Sciences
OTHER
Responsible Party
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Principal Investigators
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Liangding Hu, M.D.
Role: PRINCIPAL_INVESTIGATOR
Affiliated Hospital to Academy of Military Medical Sciences
Locations
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Department of Hematopoietic Stem Cell Transplantation
Beijing, , China
Countries
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Central Contacts
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Facility Contacts
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References
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Tang XY, Sun Y, Zhang A, Hu GL, Cao W, Wang DH, Zhang B, Chen H. Third-generation CD28/4-1BB chimeric antigen receptor T cells for chemotherapy relapsed or refractory acute lymphoblastic leukaemia: a non-randomised, open-label phase I trial protocol. BMJ Open. 2016 Dec 30;6(12):e013904. doi: 10.1136/bmjopen-2016-013904.
Other Identifiers
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307-CTC-CAR T
Identifier Type: -
Identifier Source: org_study_id
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