Humanized CAR-T Therapy for Treatment of B Cell Malignancy
NCT ID: NCT02782351
Last Updated: 2017-08-04
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/PHASE2
50 participants
INTERVENTIONAL
2016-05-31
2018-12-31
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
In interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
CAR-T
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
Interventions
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CAR-T
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
Eligibility Criteria
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Inclusion Criteria
* Survival time\>12 weeks
* B cell hematological malignancies by pathological examination
* Chemotherapy failure or recurrent B cell malignancy
* Creatinine\< 2.5mg/dl
* Glutamic-pyruvic transaminase, glutamic oxalacetic transaminase\< 3 fold of normal level
* Karnofsky Performance Status\>50% at the time of screening
* Bilirubin\<2.0mg/dl
* Adequate pulmonary, renal, hepatic, and cardiac function
* Fail in autologous or allogenic haemopoietic stem cell transplantation
* Free of leukocytes removal contraindications
Exclusion Criteria
* Active hepatitis B, active hepatitis C, or any human immunodeficiency virus (HIV) infection at the time of screening
* Previous treatment with any gene therapy product
* Abnormal vital signs
* Highly allergic constitution or history of severe allergies, especially allergy to interleukin-2
* General infection or local severe infection, or other infection that is not controlled
* Dysfunction in lung, heart, kidney and brain.
* Severe autoimmune diseases
* other symptoms that are not applicable for CAR-T
3 Years
ALL
No
Sponsors
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iCarTAB BioMed Inc.
UNKNOWN
Huaian first people's hospital
UNKNOWN
Kai Lin Xu; Jun Nian Zheng
OTHER
Responsible Party
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Kai Lin Xu; Jun Nian Zheng
President
Principal Investigators
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KaiLin Xu, MD. Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Xuzhou Medical University
Locations
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Huaian First People's Hospital
Huai'an, Jiangsu, China
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, China
Countries
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Central Contacts
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JunNian Zheng, M.D., Ph.D.
Role: CONTACT
Facility Contacts
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Chunling Wang, M.D., Ph.D.
Role: primary
Jiang Cao, M.D., Ph.D.
Role: primary
References
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van der Stegen SJ, Hamieh M, Sadelain M. The pharmacology of second-generation chimeric antigen receptors. Nat Rev Drug Discov. 2015 Jul;14(7):499-509. doi: 10.1038/nrd4597.
Davila ML, Bouhassira DC, Park JH, Curran KJ, Smith EL, Pegram HJ, Brentjens R. Chimeric antigen receptors for the adoptive T cell therapy of hematologic malignancies. Int J Hematol. 2014 Apr;99(4):361-71. doi: 10.1007/s12185-013-1479-5. Epub 2013 Dec 6.
Qi Y, Zhao M, Hu Y, Wang Y, Li P, Cao J, Shi M, Tan J, Zhang M, Xiao X, Xia J, Ma S, Qiao J, Yan Z, Li H, Pan B, Sang W, Li D, Li Z, Zhou J, Huang H, Liang A, Zheng J, Xu K. Efficacy and safety of CD19-specific CAR T cell-based therapy in B-cell acute lymphoblastic leukemia patients with CNSL. Blood. 2022 Jun 9;139(23):3376-3386. doi: 10.1182/blood.2021013733.
Chen W, Ma Y, Shen Z, Chen H, Ma R, Yan D, Shi M, Wang X, Song X, Sun C, Cao J, Cheng H, Zhu F, Sun H, Li D, Li Z, Zheng J, Xu K, Sang W. Humanized Anti-CD19 CAR-T Cell Therapy and Sequential Allogeneic Hematopoietic Stem Cell Transplantation Achieved Long-Term Survival in Refractory and Relapsed B Lymphocytic Leukemia: A Retrospective Study of CAR-T Cell Therapy. Front Immunol. 2021 Oct 29;12:755549. doi: 10.3389/fimmu.2021.755549. eCollection 2021.
Other Identifiers
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XYFY2016-KL002-01
Identifier Type: -
Identifier Source: org_study_id
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