CD19 Chimeric Antigen Receptor (CAR)-Modified T Cell Therapy in Treating Patients With B-cell Malignancies
Treatment of Relapsed or Refractory B-cell Malignancies by CD19 Chimeric Antigen Receptor (CAR)-Modified T Cells
1 other identifier
interventional
80
1 country
1
Brief Summary
This is a single arm, open-label, phase 1/2 study to evaluate the safety and efficacy of anti-CD19 CAR-T cells in patients with relapsed or refractory B cell Malignancies.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Dec 2015
Longer than P75 for phase_1
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 2, 2015
CompletedFirst Submitted
Initial submission to the registry
November 13, 2016
CompletedFirst Posted
Study publicly available on registry
November 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2021
CompletedMay 10, 2019
May 1, 2019
5.1 years
November 13, 2016
May 8, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of participants with adverse events
Therapy-related adverse events were recorded and assessed according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, Version 4.0)
5 years
Secondary Outcomes (5)
One-month remission rate
1 month
Overall survival
5 years
Event-free survival
5 years
Relapse-free survival
5 years
Rate and quantity of anti-CD19 CAR-T cells in bone marrow cells and peripheral blood cells
5 years
Study Arms (1)
Second generation CAR-T cells
EXPERIMENTALPatients receive CD19 CAR-T cells transduced with a lentiviral vector on days 0, 1, and 2 in the absence of disease progression or unacceptable toxicity.
Interventions
Eligibility Criteria
You may qualify if:
- The patient is pathologically and histologically confirmed as CD19 + B cell tumors, and has no effective treatment options currently, such as chemotherapy or autologous hematopoietic stem cell transplantation (auto-HSCT); or patients voluntarily choose CD19 CAR-T cells as a first treatment;
- B cell hematological malignancies include the following three categories:
- B-cell acute lymphocytic leukemia (B-ALL);
- Indolent B-cell lymphoma (CLL, FL, MZL, LPL);
- Aggressive B-cell lymphoma (DLBCL, BL, MCL);
- \< 70 years old;
- Expected survival time \> 6 months;
- Female patients around childbearing age, negative pregnancy test before trial, and agreed to take effective contraceptive measures during the trial until the last visit;
- Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.
You may not qualify if:
- With a history of epilepsy or other central nervous system diseases;
- Having graft-versus-host reaction, requires the use of immunosuppressants;
- The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System);
- Pregnant or lactating women (safety of this therapy for the unborn child is unknown);
- Not curable active infection;
- Patients with active hepatitis B or hepatitis C virus infection;
- Combined use of systemic steroids within two weeks (except use of inhaled steroid recently or currently);
- Using product of gene therapy before;
- Creatinine\> 2.5 mg / dl (221.0 umol/L); ALT / AST\> 3 X the normal amount; Bilirubin\> 2.0 mg / dl (34.2 umol/L);
- Patients suffering from other uncontrolled diseases, and researchers believe that the patient is not suitable for trial;
- Patients with HIV-infection;
- Any situation that may increase the risk of patients or interfere with test results.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Wuhan Sian Medical Technology Co., Ltdlead
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technologycollaborator
- Jingzhou Central Hospitalcollaborator
- Xiangyang Central Hospitalcollaborator
- People Hospital Of Yichangcollaborator
Study Sites (1)
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 027, China
Related Publications (2)
Du M, Mayombo RTM, Liu J, Zhang Y, Liao D, Hu Y, Mei H. The impact of obesity and its related underlying diseases on cytokine release syndrome and the efficacy of CAR-T therapy in treating B-cell malignancies. Ann Hematol. 2025 Mar;104(3):1887-1895. doi: 10.1007/s00277-025-06338-6. Epub 2025 Apr 8.
PMID: 40195173DERIVEDZhang Y, Zhou F, Wu Z, Li Y, Li C, Du M, Luo W, Kou H, Lu C, Mei H. Timing of Tocilizumab Administration Under the Guidance of IL-6 in CAR-T Therapy for R/R Acute Lymphoblastic Leukemia. Front Immunol. 2022 Jun 21;13:914959. doi: 10.3389/fimmu.2022.914959. eCollection 2022.
PMID: 35799791DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yu Hu, M.D., Ph.D
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 13, 2016
First Posted
November 16, 2016
Study Start
December 2, 2015
Primary Completion
January 1, 2021
Study Completion
December 1, 2021
Last Updated
May 10, 2019
Record last verified: 2019-05