A Clinical Research of CAR T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
A Clinical Research of Chimeric Antigen Receptor (CAR) T Cells Targeting CD19 Positive Malignant B-cell Derived Leukemia and Lymphoma
1 other identifier
interventional
45
1 country
1
Brief Summary
The main purpose of this research is to verify the safety of CD19 targeted chimeric antigen receptor T cells and to determine the proper dosage of CAR T cells infused.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1 leukemia
Started Dec 2014
Longer than P75 for phase_1 leukemia
1 active site
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
December 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 25, 2015
CompletedFirst Posted
Study publicly available on registry
January 29, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2023
CompletedJune 25, 2019
June 1, 2019
8 years
January 25, 2015
June 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Adverse events of each patient.
Determine the toxicity profile of the CD19 targeted CAR T cells with Common Toxicity Criteria for Adverse Effects (CTCAE) version 4.0.
3 years
Secondary Outcomes (3)
Survival time of Anti-CD19 CAR T cells in vivo.
3 years
Efficacy of anti-CD19 CAR T cells assessed by the ability of CAR T cells to kill leukemia/lymphoma cells
12 weeks
Maximum tolerated dose (MTD) of CD19 targeted CAR T cells.
4 weeks
Study Arms (3)
Acute Lymphoblastic Leukemia
OTHERAcute lymphoblastic leukemia treated with chimeric antigen receptor modified T cells targeting CD19.
Chronic Lymphcytic Leukemia
OTHERChronic lymphocytic leukemia with chimeric antigen receptor modified T cells targeting CD19.
Non-Hodgkin Lymphoma
OTHERNon-hodgkin lymphoma treated with chimeric antigen receptor modified T cells targeting CD19.
Interventions
T cells modified with CD19 targeted chimeric antigen receptor.
Eligibility Criteria
You may qualify if:
- Relapsed or refractory B cell derived acute lymphoblastic leukemia(ALL), chronic lymphocytic leukemia(CLL) and non-hodgkin lymphoma.
- KPS\>60.
- Life expectancy\>3 months.
- Gender unlimited, age from 4 years to 75 years.
- Disease progresses but reserves reaction to recent treatments.
- Patients who have failed at least one line of a standard treatment.
- No serious mental disorder.
- Patients must have adequate cardiac function(no cardiac disease, LVEF≥40% ), adequate pulmonary function as indicated by room air oxygen saturation of \>94%, and adequate renal function(Cr≤133umol/L).
- No other serious diseases(autoimmune disease, immunodeficiency etc.).
- No other tumors.
- Patients volunteer to participate in the research.
You may not qualify if:
- HIV affected.
- Patients are allergic to cytokines.
- Central nervous system leukemia within 28 days.
- Uncontrolled active infection.
- Acute or chronic GVHD.
- Treated with T cell inhibitor.
- Pregnancy and nursing females.
- Other situations we think improper for the research.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Southwest Hospital of Third Millitary Medical University
Chongqing, Chongqing Municipality, 400000, China
Related Publications (2)
Htun KT, Gong Q, Ma L, Wang P, Tan Y, Wu G, Chen J. Successful Treatment of Refractory and Relapsed CNS Acute Lymphoblastic Leukemia With CD-19 CAR-T Immunotherapy: A Case Report. Front Oncol. 2021 Aug 26;11:699946. doi: 10.3389/fonc.2021.699946. eCollection 2021.
PMID: 34513679DERIVEDHeng G, Jia J, Li S, Fu G, Wang M, Qin D, Li Y, Pei L, Tian X, Zhang J, Wu Y, Xiang S, Wan J, Zhu W, Zhang P, Zhang Q, Peng X, Wang L, Wang P, Wei Z, Zhang Y, Wang G, Chen X, Zhang C, Sun Y, Zhao W, Fan Y, Yang Z, Chen J, Qian C. Sustained Therapeutic Efficacy of Humanized Anti-CD19 Chimeric Antigen Receptor T Cells in Relapsed/Refractory Acute Lymphoblastic Leukemia. Clin Cancer Res. 2020 Apr 1;26(7):1606-1615. doi: 10.1158/1078-0432.CCR-19-1339. Epub 2019 Nov 15.
PMID: 31732519DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Cheng Qian, MD, PhD
Biotherapy Center of Southwest Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher of Biotherpy Center
Study Record Dates
First Submitted
January 25, 2015
First Posted
January 29, 2015
Study Start
December 1, 2014
Primary Completion
December 1, 2022
Study Completion
December 1, 2023
Last Updated
June 25, 2019
Record last verified: 2019-06