What question did this study set out to answer?

To evaluate the safety, feasibility, and biological activity of genetically engineered autologous CD19-specific chimeric antigen receptor (CAR) T-cells in patients with recurrent or refractory follicular lymphoma.

November 16, 2007Blood

A First-In-Human Clinical Trial of Adoptive Therapy Using CD19-Specific Chimeric Antigen Receptor Re-Directed T-Cells for Recurrent/Refractory Follicular Lymphoma.

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Authors

MJMichael C. JensenBrigham Young University LPLeslie PopplewellCity of Hope DDDavid DiGiustoCity Of Hope National Medical Center

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Implication

Clinical trial evaluates the safety of CD19-targeted CAR T-cell therapy in recurrent follicular lymphoma, highlighting the initial clinical translation of genetically engineered cell therapy.

Key Points

To evaluate the safety, feasibility, and biological activity of genetically engineered autologous CD19-specific chimeric antigen receptor (CAR) T-cells in patients with recurrent or refractory follicular lymphoma.
Conducted an FDA-authorized clinical trial (BB-IND#11411) administering autologous cytolytic T-lymphocytes engineered to express an anti-CD19 CAR coupled to CD3 zeta and a HyTK selection-suicide transgene.
Implemented intra-patient dose escalation from 100x10^6 to 2,000x10^6 cells/m^2, preceded by rituximab and fludarabine conditioning and supported by low-dose subcutaneous recombinant human IL-2.
Tracked cellular persistence via quantitative PCR and assessed disease response across peripheral blood, bone marrow, and lymph nodes using RT-qPCR and CT/PET imaging.
Anti-CD19 CAR+/HyTK+ CD8+ effector T-cells were reliably generated from peripheral blood and expanded to clinically targetable cell doses.
Engineered T-cells exhibited HLA-independent cytolytic activity against CD19+ targets, IL-2-dependent growth, and sensitivity to ganciclovir ablation.
Initial clinical administration established the feasibility of the dose-escalation protocol and correlative monitoring of cell persistence and disease burden.

Cite This Study

Jensen et al. (2007) studied this question.

synapsesocial.com/papers/6a86f5f4a810ea404bcf993f https://doi.org/10.1182/blood.v110.11.288.288

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Implication

Clinical trial evaluates the safety of CD19-targeted CAR T-cell therapy in recurrent follicular lymphoma, highlighting the initial clinical translation of genetically engineered cell therapy.

A First-In-Human Clinical Trial of Adoptive Therapy Using CD19-Specific Chimeric Antigen Receptor Re-Directed T-Cells for Recurrent/Refractory Follicular Lymphoma.

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Implication

Key Points

Cite This Study

A First-In-Human Clinical Trial of Adoptive Therapy Using CD19-Specific Chimeric Antigen Receptor Re-Directed T-Cells for Recurrent/Refractory Follicular Lymphoma.

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Implication

Key Points

Cite This Study

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