- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02992834
Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for CD19+ B Cell Lymphoma
Anti-CD19:TCRζ Chimeric Antigen Receptor-T Cells in the Treatment for Chemotherapy-resistant or Refractory CD19+B Cell Lymphoma:a Double-arm, Single Center, Open-label Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Contact
- Name: Jingting Jiang, Professor
- Email: jjtnew@163.com
Study Locations
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Jiangsu
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Changzhou, Jiangsu, China, 213003
- First People's Hospital of Changzhou
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Contact:
- Qi Zhou, Doctor
- Email: dr_qzhou@163.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
Enrollment for enough male or female patients with CD19+ hematological malignancies, without regimens for cure (autologous or allogeneic stem cell transplantation), and having a poor prognosis (several months to 2 years) under current optional regimens
- Age ranges from 18 to 70 years old
- Expected survival time longer than 12 weeks
- Performance status score 0-2
Pathologically confirmed CD19+ lymphoma (CD19+ follicular lymphoma, Mantle cell lymphoma, diffuse large B cell lymphoma) and meets at least one of follows:
- 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
- recurrence develops after stem cell transplantation
- diagnosis confirmed but refusing to receive conventional therapy
- Creatinine<2.5 mg/dl;
- alanine aminotransferase/aspartate aminotransferase lower than 3 folds of normal range
- Bilirubin<2.0 mg/dl;
- Venous channel available and no contraindications for leukocyte collection
- Reliable contraception from the beginning to 30 days after discontinuation of therapy
- Informed consent signed
Exclusion Criteria:
- Central nerve system invasion with symptoms
- Other concurrent uncontrolled malignancies
- Hepatitis B infection or active period of hepatitis C, HIV infection
- Other uncontrolled diseases hampering the intervention in the study
- Coronary heart disease, angina, myocardial infarction, arrhythmia, cerebral thrombosis, cerebral hemorrhage and other serious cardiovascular or cerebrovascular diseases.
- Grade 2-3 or uncontrolled hypertension
- History of uncontrolled mental disease
- Not suitable for participation judged by researchers
- Immunosuppressive agents administered due to organ transplantation, not including recent or current inhaled corticosteroid
- 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
- 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)
- 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.
- Pregnancy or lactation, or pregnancy planned during the study or in 2 months after the study
- 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
- Systematic active or uncontrolled infection (excluding infection of urinary tract or upper respiratory tract infection) in 14 days before the randomization
- Informed consent not signed or study rules violated
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: 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
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IL-2 stimulated, CD28-ζ-vector transfected T cells(TCRζ chimeric antigen receptor-T cell), were administered at 1×106/kg by single infusion
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ACTIVE_COMPARATOR: 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
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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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
overall survival
Time Frame: 5 year
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5 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
progression-free survival
Time Frame: 56 day
|
56 day
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Objective Response Rate
Time Frame: 56 day
|
56 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jingting Jiang, Professor, The First People's Hospital Of Changzhou
Publications and helpful links
General Publications
- 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. Erratum In: PLoS One. 2017 Feb 15;12 (2):e0172640.
Study record dates
Study Major Dates
Study Start
Primary Completion (ANTICIPATED)
Study Completion (ANTICIPATED)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CAAA
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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