Delving into the Latest Updates on K562/GM-CSF vaccine(The Johns Hopkins University) with Synapse

The purpose of this research study is to determine if the GM-K562/leukemia cell vaccine can be safely given soon after allogeneic marrow or blood stem cell transplant. The GM-K562/leukemia cell vaccine is composed of a cultured cell line that has been genetically modified to secrete GM-CSF, a naturally occuring substance in the body that stimulates the immune system. The vaccine is a mixture of the GM-K562 cells (radiated to prevent them from growing in the participants body) with the participant's previously frozen and killed leukemia cells. By mixing the GM-K562 with the leukemia cells, we would like to study whether this vaccine combination will stimulate the participant's new immune system to recognize and fight against their MDS/AML cancer cells.

Start Date01 Nov 2008

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

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NCT00694330 / CompletedPhase 1IIT

A Phase I Study of Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor

This research study is testing the safety of a vaccination of cells called GM-K562 cells mixed with the participants own irradiated tumor cells. The GM-K562 cells have been modified in the laboratory to secrete the protein GM-CSF. This protein can be effective in stimulating an immune response to cancer. This newly developed vaccine may stop cancer cells from growing.

Start Date01 Jun 2008

Sponsor / Collaborator

The General Hospital Corp.

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NCT00442130 / CompletedPhase 1IIT

Reduced Intensity Stem Cell Transplantation for Advanced Chronic Lymphocytic Leukemia Followed by Vaccination With Lethally Irradiated Autologous Tumor Cells Admixed With Granulocyte Macrophage-colony Stimulating Factor Secreting K562 Cells

The purpose of this research study is to assess the safety and immune activity of a vaccine made from the participant's own cancer cells, when administered after a reduced intensity transplant. In recent years, researchers at Dana-Farber Cancer Institute have discovered that vaccines made from a patients's own cancer cells, that have been engineered in the laboratory to produce a protein called GM-CSF, can be effective in stimulating a powerful immune response specific to that cancer.

Start Date01 Feb 2007

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+1]

100 Clinical Results associated with K562/GM-CSF vaccine(The Johns Hopkins University)

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100 Translational Medicine associated with K562/GM-CSF vaccine(The Johns Hopkins University)

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100 Patents (Medical) associated with K562/GM-CSF vaccine(The Johns Hopkins University)

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10

Literatures (Medical) associated with K562/GM-CSF vaccine(The Johns Hopkins University)

01 Dec 2021·Leukemia ResearchQ4 · MEDICINE

A randomized, phase II trial of adjuvant immunotherapy with durable TKI-free survival in patients with chronic phase CML

Q4 · MEDICINE

Article

Author: Borrello, Ivan ; Jones, Richard J ; Ferguson, Anna ; Webster, Jonathan A ; Blackford, Amanda L ; Zahurak, Marianna ; Warlick, Erica ; Smith, B Douglas ; Robinson, Tara M

PURPOSEChronic myeloid leukemia (CP-CML) patients can achieve undetectable minimal residual disease (UMRD) and discontinue tyrosine kinase inhibitors (TKIs). Cellular immunity plays an important role in CML disease control. We conducted a randomized, non-blinded phase II trial of adjuvant immunotherapy with TKIs to facilitate TKI discontinuation.METHODSTKI-treated patients with CP-CML were randomized to receive the K562/GM-CSF vaccine (vaccine) OR Interferon-α + Sargramostim (IFN). If UMRD was achieved, then all treatment was stopped. Patients who did not achieve UMRD within one year, had a molecular relapse, or discontinued therapy for toxicity could crossover.RESULTSThirty-four patients were randomized to IFN (n = 18) or vaccine (n = 16), and 21 patients crossed over (IFN⟶vaccine: n = 9, vaccine⟶IFN, n = 12). TKIs at enrollment included imatinib (n = 31), nilotinib (n = 2), and dasatinib (n = 1). No patients discontinued vaccine due to side effects, while 33 % of IFN-treated patients discontinued treatment. More patients randomized to IFN (47.4 %, 95 % CI: 16.7-66.7 %) versus vaccine (25.0 %, 95 % CI: 0.5-43.5 %) achieved UMRD within one year. Seven patients randomized to IFN discontinued treatment with 28.6 % (95 % CI: 8.9-92.2 %) sustaining treatment-free remission (TFR) at 1 year, while three patients randomized to vaccine discontinued treatment with none sustaining TFR. Including crossover, there was a cumulative discontinuation success rate of 36.4 % (95 % CI: 16.6 %-79.5 %) after adjuvant IFN. Patients who sustained TFR received a median of 29 months of imatinib prior to discontinuation.CONCLUSIONAdjuvant IFN led to durable TFRs with limited prior TKI exposure with comparable success to prior discontinuation trials, but many patients stopped IFN early.

01 Nov 2020·Medical OncologyQ4 · MEDICINE

B7-1 and GM-CSF enhance the anti-tumor immune effect of DC-tumor fusion vaccine in the treatment of prostate cancer

Q4 · MEDICINE

Article

Author: Wang, Haitao ; Li, Changying ; Li, Jianmin ; Lian, Tong ; Hao, Xiaodong

The treatment of castration-resistant prostate cancer (CRPC) is always a difficulty in the clinic. Most patients with localized tumor eventually develop CRPC, even if hormone therapy is initially effective. Increasing evidence shows immunotherapy has special advantages compared with traditional therapy in cancer treatment. In this study, we constructed the DC-PC-3 fusion vaccine with B7-1- and GM-CSF-specific modification, and studied its ability to stimulate specific immune response and anti-tumor effect in vitro. The results showed that fusion of DC and tumor cells can improve the expression of associated antigens of DCs. DC-tumor fusion vaccine can strongly promote T cell proliferation and IFN-γ secretion and induce a significant tumor-specific cytotoxic T lymphocyte response. In addition, the B7-1/GM-CSF-modified fusion vaccine showed a more significant anti-tumor effect and greater ability to stimulate the immune response than that without specific modification in vitro. Thus, GM-CSF/B7-1-modified fusion vaccine might be used as a potential therapy strategy for prostate cancer.

02 Dec 2018·Leukemia & LymphomaQ4 · MEDICINE

Pilot trial of K562/GM-CSF whole-cell vaccination in MDS patients

Q4 · MEDICINE

Article

Author: Warlick, Erica ; Smith, B. Douglas ; Prince, Gabrielle T. ; Robinson, Tara M. ; Ferguson, Anna ; Thoburn, Chris ; Borrello, Ivan M. ; Kasamon, Yvette L. ; Hess, Allan

Myelodysplastic syndromes (MDS) are a heterogeneous group of clonal hematopoietic stem cell malignancies. Currently, approved drugs are given with non-curative intent as the only known cure is allogeneic bone marrow transplantation, which relies on the donor's immune system driving an allogeneic effect. Previous efforts to harness the endogenous immune system have been less successful. We present the results of a pilot study of K562/GM-CSF (GVAX) whole-cell vaccination in MDS patients. The primary objective of safety was met as there were no serious adverse events. One patient had a decrease in transfusion requirements and another demonstrated hematologic improvement suggesting a signal for clinical activity. In vitro correlative studies indicated biological effects on immune cells following vaccination. Although only a pilot study, results are encouraging that an immunotherapeutic approach with a whole-cell vaccine may be feasible in MDS patients.

100 Deals associated with K562/GM-CSF vaccine(The Johns Hopkins University)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Acute Myeloid Leukemia	Phase 2	US	National Institutes of Health	01 Nov 2008
Anemia, Refractory, With Excess of Blasts	Phase 2	US	National Institutes of Health	01 Nov 2008
Chronic Myelomonocytic Leukemia	Phase 2	US	National Institutes of Health	01 Nov 2008
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	National Cancer Institute	-
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	Sidney Kimmel Cancer Center	-
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	The Johns Hopkins University	-