Humanized CAR-T Therapy for Treatment of B Cell Malignancy
1 other identifier
interventional
50
1 country
2
Brief Summary
The present study evaluates the safety and efficacy of humanized Chimeric antigen receptor T cells (CAR-T) in treating recurrent or refractory B cell malignancy targeting CD19 with a humanized scFv. All participants will receive autologous chimeric antigen receptor engineered T cells.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2016
Typical duration for phase_1
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2016
CompletedFirst Submitted
Initial submission to the registry
May 17, 2016
CompletedFirst Posted
Study publicly available on registry
May 25, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedAugust 4, 2017
August 1, 2017
2.1 years
May 17, 2016
August 3, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
CAR-T cells persistence in peripheral blood
The presence of CAR T cells in patients' peripheral blood will be quantified with real time qPCR
12 months
Secondary Outcomes (1)
B cell number and immunoglobulins in peripheral blood
12 months
Study Arms (1)
CAR-T
EXPERIMENTALIn interventional studies, patients enrolled will receive autologous 2nd generation CAR-T cells, which contain a humanized single chain antibody sequence against CD19.
Interventions
Patients will be infused with autologous CAR-T infusion in a dose escalating manner.
Eligibility Criteria
You may qualify if:
- Age≥3 at the time of consent
- 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
You may not qualify if:
- Pregnant or nursing women
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Kai Lin Xu; Jun Nian Zhenglead
- iCarTAB BioMed Inc.collaborator
- Huaian first people's hospitalcollaborator
Study Sites (2)
Huaian First People's Hospital
Huai'an, Jiangsu, 223300, China
Affiliated hospital of Xuzhou medical college
Xuzhou, Jiangsu, 221000, China
Related Publications (4)
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.
PMID: 26129802BACKGROUNDDavila 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.
PMID: 24311149RESULTQi 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.
PMID: 35338773DERIVEDChen 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.
PMID: 34777367DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
KaiLin Xu, MD. Ph.D.
Xuzhou Medical University
Central Study Contacts
JunNian Zheng, M.D., Ph.D.
CONTACT
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- President
Study Record Dates
First Submitted
May 17, 2016
First Posted
May 25, 2016
Study Start
May 1, 2016
Primary Completion
June 1, 2018
Study Completion
December 1, 2018
Last Updated
August 4, 2017
Record last verified: 2017-08
Data Sharing
- IPD Sharing
- Will share