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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|ClinicalTrials.gov Identifier: NCT04289220|
Recruitment Status : Not yet recruiting
First Posted : February 28, 2020
Last Update Posted : February 28, 2020
|Condition or disease||Intervention/treatment||Phase|
|B Cell Lymphoma B-cell Acute Lymphoblastic Leukemia||Biological: Anti-CD19 CAR-T Cells Injection||Phase 1|
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.
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-α, IL-2, GM-CSF, IL-10, and IL-6 were also determined.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Clinical Trial of Anti-CD19 Chimeric Antigen Receptor in PiggyBac Transposon-Engineered T Cells for the Treatment of Patients With Relapsed/Refractory/High-risk B-cell Lymphoma or B-cell Acute Lymphoblastic Leukemia|
|Estimated Study Start Date :||March 15, 2020|
|Estimated Primary Completion Date :||March 15, 2023|
|Estimated Study Completion Date :||September 15, 2023|
Experimental: Anti-CD19 CAR-T Cells Injection
Anti-CD19 CAR-T Cells Injection, Dosage form：injection Dosage:1-2.5x10^6/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time
Biological: Anti-CD19 CAR-T Cells Injection
Dosage form：injection Dosage:1-2.5x10^6 cells/kg, 100ml/time, The CAR-T cells will be administered by i.v. injection over 20-30 minutes, Frequency: total one time
- Grade and number of cytokine release syndrome and neurotoxic effects in participants receiving treatment [ Time Frame: 14 day ]Anti-CD19 CAR-T cells growing use requires further education/training and prompt management of safety and tolerability.
- Persistence of anti-CD19 CAR-T cells in participants [ Time Frame: 1 year ]Copies numbers of CAR in peripheral blood (PB)
- Overall survival [ Time Frame: 3 years ]For all subjects, overall survival refers to the period from being included in the test group to death caused by any reason
- Progress Free Survival [ Time Frame: 3 years ]Progression-free survival refers to the period between the start of treatment for participants and the observation of disease progression or death for any reason.
- Duration of Response after administration [ Time Frame: 3 years ]Duration of Response after administration
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04289220
|Contact: Zongliu Houemail@example.com|
|Kunming Yan'an Hospital|
|Kunming, Yunnan, China, 650000|
|Contact: Lin Li firstname.lastname@example.org|
|Study Director:||Zongliu Hou||Kunming Yan'an Hospital|