Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma
NCT ID: NCT02992834
Last Updated: 2016-12-14
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
PHASE4
10 participants
INTERVENTIONAL
2016-12-31
2022-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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IL-2 pre-treated CD19 cells
Initial therapy: IL-2 (interleukin,IL)stimulated, CD28-ζ-vector (cluster of differentiation 28,CD28)transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
IL-2 pre-treated CD19 cells
IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
IL-7/IL-15 pre-treated CD19 cells
Initial therapy: IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
IL-7/IL-15 pre-treated CD19 cells
IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
Interventions
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IL-2 pre-treated CD19 cells
IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
IL-7/IL-15 pre-treated CD19 cells
IL-7/IL-15 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell)， were administered at 1×106/kg by single infusion
Eligibility Criteria
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Inclusion Criteria
1. Age ranges from 18 to 70 years old
2. Expected survival time longer than 12 weeks
3. Performance status score 0-2
4. Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
1. having received at least 2-4 cycles of combined chemotherapy (excluding monoclonal antibody monotherapy, such as rituximab) but do not reach a complete response; recurrent disease; not applicable for conventional stem cell transplantation; being partial responsible or stable but not complete responsible after the latest therapy
2. recurrence develops after stem cell transplantation
3. diagnosis confirmed but refusing to receive conventional therapy
5. Creatinine\<2.5 mg/dl；
6. alanine aminotransferase/aspartate aminotransferase lower than 3 folds of normal range
7. Bilirubin\<2.0 mg/dl；
8. Venous channel available and no contraindications for leukocyte collection
9. Reliable contraception from the beginning to 30 days after discontinuation of therapy
10. Informed consent signed
Exclusion Criteria
2. Other concurrent uncontrolled malignancies
3. Hepatitis B infection or active period of hepatitis C, HIV infection
4. Other uncontrolled diseases hampering the intervention in the study
5. Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
6. Grade 2-3 or uncontrolled hypertension
7. History of uncontrolled mental disease
8. Not suitable for participation judged by researchers
9. Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
10. Medical history of mental diseases or abnormities of lab tests might increase the risks of participation in study or drug administration, or interfering the results
11. Screening suggesting transfection efficiency of targeting cells lower than 30% or cell expansion deficiency under CD3/CD28 (cluster of differentiation 3,CD3)stimulation (less than 5 folds)
12. Unstable pulmonary embolism, deep venous thromboembolism or other major arterial/venous thromboembolism events develop in 30 days before the randomization. If anti-coagulation therapy is received, the treatment dose should reach stability before the randomization.
13. Pregnancy or lactation, or pregnancy planned during the study or in 2 months after the study
14. Reliable contraception not accepted during the study or in 2 months after the study. Female subjects are required to provide negative results from serum or urine pregnancy test 48 hours before therapy
15. Systematic active or uncontrolled infection (excluding infection of urinary tract or upper respiratory tract infection) in 14 days before the randomization
16. Informed consent not signed or study rules violated
18 Years
70 Years
ALL
No
Sponsors
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jiangjingting
OTHER
Responsible Party
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jiangjingting
Professor
Principal Investigators
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Jingting Jiang, Professor
Role: PRINCIPAL_INVESTIGATOR
The First People's Hospital of Changzhou
Locations
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First People's Hospital of Changzhou
Changzhou, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Qi Zhou, Doctor
Role: primary
References
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Rafiq S, Purdon TJ, Daniyan AF, Koneru M, Dao T, Liu C, Scheinberg DA, Brentjens RJ. Optimized T-cell receptor-mimic chimeric antigen receptor T cells directed toward the intracellular Wilms Tumor 1 antigen. Leukemia. 2017 Aug;31(8):1788-1797. doi: 10.1038/leu.2016.373. Epub 2016 Dec 7.
Minagawa K, Jamil MO, Al-Obaidi M, Pereboeva L, Salzman D, Erba HP, Lamb LS, Bhatia R, Mineishi S, Di Stasi A. In Vitro Pre-Clinical Validation of Suicide Gene Modified Anti-CD33 Redirected Chimeric Antigen Receptor T-Cells for Acute Myeloid Leukemia. PLoS One. 2016 Dec 1;11(12):e0166891. doi: 10.1371/journal.pone.0166891. eCollection 2016.
Other Identifiers
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CAAA
Identifier Type: -
Identifier Source: org_study_id