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1.
Ann Hematol ; 100(10): 2529-2539, 2021 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-34304287

RESUMEN

We conducted a phase II clinical trial to develop an autologous EBV-specific T cell product (baltaleucel T) for advanced, relapsed ENKTL. Among 47 patients who provided whole blood starting material for manufacturing the product, 15 patients received a median of 4 doses of baltaleucel T. Thirty-two (68%) patients did not receive baltaleucel-T due to manufacturing failure, rapid disease progression, and death. Of the 15 patients, 10 patients had measurable disease at baseline (salvage cohort), and 5 patients had no disease at baseline assessment (adjuvant cohort). In the 15 patients, the median follow-up duration was 10.2 months (range 2.0-23.5 months), median progression-free survival (PFS) was 3.9 months, and the median overall survival (OS) was not reached. Patients in the salvage cohort achieved a 30% complete response (CR) and a 50% overall response rate (ORR). In the adjuvant cohort, disease progression was reported in three patients and two patients did not relapse during study follow-up. When we compared survival outcomes of seven responders and eight non-responders, the PFS (P = 0.001) and OS (P = 0.014) of responders proved statistically superior to that of non-responders. Baltaleucel-T was well tolerated. We have performed a phase II clinical trial of autologous EBV-specific T cell treatment (baltaleucel-T) in R/R ENKTL. Autologous EBV-specific T cells were well tolerated and demonstrated single-agent activity in R/R ENTKL.


Asunto(s)
Infecciones por Virus de Epstein-Barr/inmunología , Herpesvirus Humano 4/inmunología , Linfoma Extranodal de Células NK-T/inmunología , Linfoma Extranodal de Células NK-T/terapia , Linfocitos T/inmunología , Adulto , Anciano , Infecciones por Virus de Epstein-Barr/complicaciones , Infecciones por Virus de Epstein-Barr/terapia , Femenino , Humanos , Inmunoterapia Adoptiva , Linfoma Extranodal de Células NK-T/complicaciones , Masculino , Persona de Mediana Edad , Linfocitos T/trasplante , Resultado del Tratamiento , Adulto Joven
2.
Blood ; 101(5): 1718-26, 2003 Mar 01.
Artículo en Inglés | MEDLINE | ID: mdl-12406881

RESUMEN

In murine models, transgenic chemokine-cytokine tumor vaccines overcome many of the limitations of single-agent immunotherapy by producing the sequence of T-cell attraction followed by proliferation. The safety and immunologic effects of this approach in humans were tested in 21 patients with relapsed or refractory neuroblastoma. They received up to 8 subcutaneous injections of a vaccine combining lymphotactin (Lptn)- and interleukin-2 (IL-2)-secreting allogeneic neuroblastoma cells in a dose-escalating scheme. Severe adverse reactions were limited to reversible panniculitis in 5 patients and bone pain in 1 patient. Injection-site biopsies revealed increased cellularity caused by infiltration of CD4+ and CD8+ lymphocytes, eosinophils, and Langerhans cells. Systemically, the vaccine produced a 2-fold (P =.035) expansion of CD4+ T cells, a 3.5-fold (P =.039) expansion of natural killer (NK) cells, a 2.1-fold (P =.014) expansion of eosinophils, and a 1.6-fold (P =.049) increase in serum IL-5. When restimulated in vitro by the immunizing cell line, T cells collected after vaccination showed a 2.3-fold increase (P =.02) of T-helper (TH2)-type CD3+IL-4+ cells. Supernatant collected from restimulated cells showed increased amounts of IL-4 (11.4-fold; P =.021) and IL-5 (8.7-fold; P =.002). Six patients had significant increases in NK cytolytic activity. Fifteen patients made immunoglobulin G (IgG) antibodies that bound to the immunizing cell line. Measurable tumor responses included complete remission in 2 patients and partial response in 1 patient. Hence, allogeneic tumor cell vaccines combining transgenic Lptn with IL-2 appear to have little toxicity in humans and can induce an antitumor immune response.


Asunto(s)
Vacunas contra el Cáncer/uso terapéutico , Quimiocinas C , Interleucina-2/uso terapéutico , Linfocinas/uso terapéutico , Neuroblastoma/terapia , Sialoglicoproteínas/uso terapéutico , Adolescente , Recuento de Linfocito CD4 , Linfocitos T CD4-Positivos/inmunología , Vacunas contra el Cáncer/efectos adversos , Niño , Preescolar , Citocinas/sangre , ADN Complementario/genética , Femenino , Humanos , Hipersensibilidad Tardía/etiología , Esquemas de Inmunización , Inmunoglobulina G/biosíntesis , Inmunoglobulina G/inmunología , Inmunofenotipificación , Lactante , Inyecciones Subcutáneas , Interleucina-2/administración & dosificación , Interleucina-2/genética , Interleucina-2/metabolismo , Células Asesinas Naturales/inmunología , Linfocinas/administración & dosificación , Linfocinas/genética , Linfocinas/metabolismo , Masculino , Neuroblastoma/patología , Paniculitis/etiología , Proteínas Recombinantes de Fusión/administración & dosificación , Proteínas Recombinantes de Fusión/metabolismo , Proteínas Recombinantes de Fusión/uso terapéutico , Inducción de Remisión , Terapia Recuperativa , Sialoglicoproteínas/administración & dosificación , Sialoglicoproteínas/genética , Sialoglicoproteínas/metabolismo , Piel/patología , Células Th2/inmunología , Transducción Genética , Resultado del Tratamiento , Células Tumorales Cultivadas/efectos de los fármacos , Células Tumorales Cultivadas/metabolismo , Células Tumorales Cultivadas/efectos de la radiación , Células Tumorales Cultivadas/trasplante
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