Anti-CD19 CAR in PiggyBac Transposon-Engineered T Cells for Relapsed/Refractory B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia
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- STATUS
- Recruiting
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- End date
- Sep 15, 2023
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- participants needed
- 10
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- sponsor
- Yan'an Affiliated Hospital of Kunming Medical University
Summary
Our previous study demonstrated that anti-CD19 chimeric antigen receptor in piggyBac transposon-engineered T cells have strong tumor-killing activity in vitro and therapeutic effects in cell line-derived xenograft models, and no obvious side effects such as neurotoxicity and cytokine storm occurred. Therefore, we want to evaluate the safety and clinical effect of anti-CD19 CAR-T cells in clinical trials.
Description
Using piggyBac transposon/transposase system to deliver genes into primary human T cells - example expression of CD19 CAR.CARs specific to the human CD19 antigen were used. All CARs contained the scFv against human CD19 (clone FMC-63), The third BBz CD28z CAR consisted of the scFv linked to the intracellular domains of CD28, 4-1BB and CD3z through a CD28 transmembrane domain;
Subjects with relapsed/refractory CD19-positive B-cell Lymphoma or B-ALL can participate if all eligibility criteria are met. All patients received chemotherapy with fludarabine and cyclophosphamide before the infusion of anti-CD19 CAR-T cells.. After the infusion, subjects will accept follow-up for side effects and effect of anti-CD19 CAR-T cells.
Follow-up :
Safety and adverse events (safety and tolerability of anti-CD19 CAR-T cell therapy within 14 days): The number and severity of adverse events, an evaluation of their association with the anti-CD19 CAR-T cell treatment, and the outcome of the adverse events. Possible adverse events include cytokine release syndrome, hypotension, reversible neurotoxicity, hypogammaglobulinemia, etc. CT was used to evaluate B-lymphoma lesions. B-ALL bone marrow samples were collected by bone marrow aspiration to assess minimal residual disease. Flow cytometry was used to detect proportion of T cells, B cells, and NK cells in the blood, and expression of CD3, CD4, CD8, anti-CD19 CAR to determine the effect of anti-CD19 CAR-T treatment. Plasma levels of the cytokines IFN-gamma, TNF-, IL-2, GM-CSF, IL-10, and IL-6 were also determined.
Data analysis:
Overall survival and progress free survival were determined by the Kaplan-Meier method, using all enrolled patients to determine overall survival.
Study procedures may be performed while hospitalized.
Details
| Condition | Lymphoma, Non-Hodgkin's Lymphoma, b cell lymphomas, B-Cell Lymphoma, Lymphoma, B-Cell, b-cell lymphomas, b cell lymphoma, B-cell Acute Lymphoblastic Leukemia |
|---|---|
| Treatment | Anti-CD19 CAR-T Cells Injection |
| Clinical Study Identifier | NCT04289220 |
| Sponsor | Yan'an Affiliated Hospital of Kunming Medical University |
| Last Modified on | 22 May 2021 |
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