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.

[+2]

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.

[+2]

NCT00361296

/ TerminatedEarly Phase 1IIT

K562/GM-CSF Vaccination in Patients With Myelodysplastic Syndrome

RATIONALE: Vaccines made from cancer cells may help the body build an effective immune response to kill abnormal cells.
PURPOSE: This clinical trial is studying how well vaccine therapy works in treating patients with myelodysplastic syndromes (MDS).

Start Date01 Sep 2007

Sponsor / Collaborator

The Sidney Kimmel Comprehensive Cancer Center

[+2]

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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5

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

14 Oct 2024·LEUKEMIA & LYMPHOMA

A phase I trial of vaccination with lethally irradiated lymphoma cells admixed with granulocyte-macrophage colony-stimulating factor secreting K562 cells for the treatment of follicular lymphoma

Article

Author: Fisher, David C. ; Redd, Robert ; Plant, Ashley ; Armand, Philippe ; Dranoff, Glenn ; McDonough, Mikaela ; Ritz, Jerome ; Jacobsen, Eric ; Freedman, Arnold ; Ihuoma, Udochukwu ; LaCasce, Ann

Several vaccine strategies have been tested for the treatment of follicular lymphoma; however, none have proven successful. In a phase I dose-escalation protocol, we developed a vaccine consisting of lethally irradiated whole lymphoma cells admixed with K562 cells that constitutively secreted granulocyte-macrophage colony-stimulating factor (GM-K562)(ClinicalTrials.gov identifier: NCT00487305). Patients with grade 1, 2, or 3 A follicular lymphoma were divided into 2 study tiers based on prior treatment and received a maximum of 6 vaccines. Vaccines contained dose levels of 5 × 10⁶ or 1 × 10⁷ GM-K562 cells admixed with autologous tumor cells at doses ranging from 1 × 10⁵ to 5 × 10⁷.Correlative studies did not demonstrate a significant immune response as assessed by delayed-type hypersensitivity reactions, B and T cell subsets, and natural killer cell subsets. Future vaccine studies should focus on identifying lymphoma-specific immunogenic proteins and modifying the vaccine immune adjuvant.

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

PURPOSE:

Chronic 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.

METHODS:

TKI-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.

RESULTS:

Thirty-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.

CONCLUSION:

Adjuvant IFN led to durable TFRs with limited prior TKI exposure with comparable success to prior discontinuation trials, but many patients stopped IFN early.

02 Dec 2018·Leukemia & lymphomaQ4 · MEDICINE

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

Q4 · MEDICINE

Article

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

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
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	National Cancer Institute	-
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	The Johns Hopkins University	-
Philadelphia chromosome positive chronic myelogenous leukemia	Phase 2	-	Sidney Kimmel Cancer Center	-
Acute Myeloid Leukemia	Phase 1	United States	Dana-Farber Cancer Institute, Inc.	01 Nov 2008
Anemia, Refractory, With Excess of Blasts	Phase 1	United States	Dana-Farber Cancer Institute, Inc.	01 Nov 2008
Chronic Myelomonocytic Leukemia	Phase 1	United States	Dana-Farber Cancer Institute, Inc.	01 Nov 2008

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Clinical Result

Indication

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Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT00361296 (CTgov)	Early Phase 1	Myelodysplastic Syndromes	9	K562/GM-CSF cell vaccine	wlqovblqzl = ijsmeftojz pzzhwhlnwd (gthqhbilrl, tlftgrhxsu - dyoeysvqjz) View more	-	16 Nov 2018
NCT00363649 (CTgov)	Phase 2	Chronic phase chronic myeloid leukemia \| Philadelphia chromosome positive chronic myelogenous leukemia	36	Interferon alfa+Sargramostim (Arm A)	kxwgsnxpqd = mrlbjwsqhr nzoygkzahk (atxoyqraum, vzsybeebao - pqqmmvsipm) View more	-	13 Nov 2018
NCT00363649 (CTgov)	Phase 2		36	GM-K562 cell vaccine (Arm B)	kxwgsnxpqd = omzynmiuhg nzoygkzahk (atxoyqraum, tnffnfjfqe - flxpiiysdv) View more	-	13 Nov 2018