Delving into the Latest Updates on CD40L-GVAX(University of South Florida) with Synapse

Overview

Basic Info

Drug Type

Therapeutic vaccine

Synonyms

Autologous tumour cell-based vaccine, Bystander GVAX Cancer Vaccine, Bystander vaccine

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Target

CD40 x CSF-2R x GM-CSF

Mechanism

CD40 agonists(Tumor necrosis factor receptor superfamily member 5 agonists), CSF-2R stimulants(Granulocyte-macrophage colony-stimulating factor receptor stimulants), GM-CSF stimulants(Macrophage colony stimulating factor 2 stimulants)

Therapeutic Areas

NeoplasmsRespiratory Diseases

Active Indication

Non-Small Cell Lung Cancer

Inactive Indication

Adenocarcinoma of LungMantle-Cell LymphomaMelanoma, Cutaneous Malignant

Originator Organization

University of South Florida

Active Organization

Cell Genesys, Inc.

Inactive Organization

H. Lee Moffitt Cancer Center & Research Institute, Inc.

Drug Highest PhasePhase 1/2

First Approval Date-

Regulation-

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The purpose of this study is to find out what effects (good and bad) a tumor vaccine (GM.CD40L) used in combination with Nivolumab will have on participants and their cancer. Another purpose of the study is to find out the maximum tolerated dose of nivolumab in combination with GM.CD40L vaccine. Investigators also want to find out if the combination of GM.CD40L and nivolumab can boost the immune system of participants like you, and how their immune system reacts, both before and after the treatment.

Start Date01 Jul 2018

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

NCT01433172

/ CompletedPhase 1/2IIT

A Randomized Phase I/II Trial Using a GM-CSF-Producing and CD40L-Expressing Bystander Cell Line (GM.CD40L) Vaccine in Combination With CCL21 for Patients With Stage IV Adenocarcinoma of the Lung

The purpose of this study is to find out what effects (good and bad) a tumor vaccine used in combination with GM.CD40L and CCL21 have on the patient and their cancer. We also want to find out if the vaccine and the drugs can boost the immune system of these patients and how their immune system reacts, both before and after the vaccine treatment.

Start Date26 Mar 2012

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

NCT00840931

/ CompletedPhase 1IIT

A Phase I Pilot Study of Immunotherapy Using Lenalidomide Plus "Bystander" Vaccine in Patients With High-Risk Myelodysplastic Syndrome (MDS)

The purpose of this study is to find out the maximum tolerated dose (MTD) of the combined therapy of lenalidomide (Revlimid®) and Granulocyte/macrophage colony stimulating factor and CD40 Ligand expressed in the K562 cell line (GM.CD40L) bystander vaccine. This research is also being done to see how well the combination of these drugs works to fight myelodysplastic syndrome (MDS).

Start Date02 Feb 2009

Sponsor / Collaborator

H. Lee Moffitt Cancer Center & Research Institute, Inc.

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100 Clinical Results associated with CD40L-GVAX(University of South Florida)

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100 Translational Medicine associated with CD40L-GVAX(University of South Florida)

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100 Patents (Medical) associated with CD40L-GVAX(University of South Florida)

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82

Literatures (Medical) associated with CD40L-GVAX(University of South Florida)

07 Sep 2020·Journal of Experimental MedicineQ1 · MEDICINE

Autologous tumor cell vaccine induces antitumor T cell immune responses in patients with mantle cell lymphoma: A phase I/II trial

Q1 · MEDICINE

Article

Author: Faham, Malek ; Moore, A. Holliston ; Frank, Matthew J. ; Weng, Wen-Kai ; Phillips, Destiny L. ; Wapnir, Irene L. ; Meyer, Everett H. ; Laport, Ginna G. ; Haabeth, Ole A.W. ; Advani, Ranjana H. ; Gupta, Neel K. ; Negrin, Robert S. ; Rezvani, Andrew R. ; Czerwinski, Debra K. ; Alizadeh, Ash A. ; Brody, Joshua D. ; Sheehan, Kevin ; Miklos, David B. ; Maeda, Lauren S. ; Khodadoust, Michael S. ; Okada, Ami ; Reddy, Sunil A. ; Levy, Ronald ; Chu, Michael P.

Here, we report on the results of a phase I/II trial (NCT00490529) for patients with mantle cell lymphoma who, having achieved remission after immunochemotherapy, were vaccinated with irradiated, CpG-activated tumor cells. Subsequently, vaccine-primed lymphocytes were collected and reinfused after a standard autologous stem cell transplantation (ASCT). The primary endpoint was detection of minimal residual disease (MRD) within 1 yr after ASCT at the previously validated threshold of ≥1 malignant cell per 10,000 leukocyte equivalents. Of 45 evaluable patients, 40 (89%) were found to be MRD negative, and the MRD-positive patients experienced early subsequent relapse. The vaccination induced antitumor CD8 T cell immune responses in 40% of patients, and these were associated with favorable clinical outcomes. Patients with high tumor PD-L1 expression after in vitro exposure to CpG had inferior outcomes. Vaccination with CpG-stimulated autologous tumor cells followed by the adoptive transfer of vaccine-primed lymphocytes after ASCT is feasible and safe.

17 Jun 2020·Science AdvancesQ1 · CROSS-FIELD

Engineering autologous tumor cell vaccine to locally mobilize antitumor immunity in tumor surgical bed

Q1 · CROSS-FIELD

ArticleOA

Author: Ding, Yaping ; Zhang, Pengcheng ; Li, Yaping ; Fang, Lei ; Jiang, Yanyan ; Wang, Dangge ; Wang, Jue ; Zhao, Zitong

A feasible and transformable cancer vaccine was designed for personalized immunotherapy of postoperative tumors.

01 Dec 2018·Cancer Immunology, ImmunotherapyQ2 · MEDICINE

A phase I/randomized phase II study of GM.CD40L vaccine in combination with CCL21 in patients with advanced lung adenocarcinoma

Q2 · MEDICINE

Article

Author: Chiappori, Alberto ; Haura, Eric B ; Tanvetyanon, Tawee ; Kelley, Linda ; Mediavilla-Varela, Melanie ; Kim, Jongphil ; Gray, Jhanelle E ; Boyle, Theresa A ; Williams, Charlie C ; Hopewell, Emily L ; Khalil, Farah ; Pinder-Schenck, Mary ; Antonia, Scott J ; Altiok, Soner ; Smilee, Renee ; Devane, Rebecca ; Creelan, Ben C ; Noyes, David

The GM.CD40L vaccine, which recruits and activates dendritic cells, migrates to lymph nodes, activating T cells and leading to systemic tumor cell killing. When combined with the CCL21 chemokine, which recruits T cells and enhances T-cell responses, additive effects have been demonstrated in non-small cell lung cancer mouse models. Here, we compared GM.CD40L versus GM.CD40L plus CCL21 (GM.CD40L.CCL21) in lung adenocarcinoma patients with ≥ 1 line of treatment. In this phase I/II randomized trial (NCT01433172), patients received intradermal vaccines every 14 days (3 doses) and then monthly (3 doses). A two-stage minimax design was used. During phase I, no dose-limiting toxicities were shown in three patients who received GM.CD40L.CCL21. During phase II, of evaluable patients, 5/33 patients (15.2%) randomized for GM.DCD40L (p = .023) and 3/32 patients (9.4%) randomized for GM.DCD40L.CCL21 (p = .20) showed 6-month progression-free survival. Median overall survival was 9.3 versus 9.5 months with GM.DCD40L versus GM.DCD40L.CCL21 (95% CI 0.70-2.25; p = .44). For GM.CD40L versus GM.CD40L.CCL21, the most common treatment-related adverse events (TRAEs) were grade 1/2 injection site reaction (51.4% versus 61.1%) and grade 1/2 fatigue (35.1% versus 47.2%). Grade 1 immune-mediated TRAEs were isolated to skin. No patients showed evidence of pseudo-progression or immune-related TRAEs of grade 1 or greater of pneumonitis, endocrinopathy, or colitis, and none discontinued treatment due to toxicity. Although we found no significant associations between vaccine immunogenicity and outcomes, in limited biopsies, one patient treated with GMCD40L.CCL21 displayed abundant tumor-infiltrating lymphocytes. This possible effectiveness warrants further investigation of GM.CD40L in combination approaches.

100 Deals associated with CD40L-GVAX(University of South Florida)

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of Lung	Phase 3	US	H. Lee Moffitt Cancer Center & Research Institute, Inc.	26 Mar 2012
Adenocarcinoma of Lung	Phase 3	US	H. Lee Moffitt Cancer Center & Research Institute, Inc.	26 Mar 2012
Melanoma, Cutaneous Malignant	Phase 3	US	H. Lee Moffitt Cancer Center & Research Institute, Inc.	01 Oct 2004
Mantle-Cell Lymphoma	Phase 3	US	H. Lee Moffitt Cancer Center & Research Institute, Inc.	01 Jul 2004
Non-Small Cell Lung Cancer	Phase 2	US	Cell Genesys, Inc.	01 May 2002

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Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01433172 (ASCO2016)	Phase 1/2	Advanced Lung Adenocarcinoma	35	GM.CD40L vaccine	(rcfpbslnwa) = eiwcxpcpkp zekzfxpczz (iygxklctkl ) View more	Negative	20 May 2016
NCT01433172 (ASCO2016)	Phase 1/2	Advanced Lung Adenocarcinoma	35	GM.CD40L.CCL21 vaccine	(rcfpbslnwa) = otaaajlvil zekzfxpczz (iygxklctkl ) View more	Negative	20 May 2016
NCT00101101 (CTgov)	Phase 2	Mantle-Cell Lymphoma	43	cyclophosphamide+prednisone+Autologous Tumor Cell-Based Vaccine+doxorubicin+IL-2+Dexamethasone+Vincristine	hwebloqscs(rhsaodlhes) = wwbsubaamr zfiqqovcfz (sidpxbxakh, kuhufdepjk - qsbzimvxxh) View more	-	04 Sep 2013
NCT01433172 (ASCO2013)	Phase 1/2	metastatic non-small cell lung cancer	73	GM.CD40L	(sawcvhurzm) = ezzdjynnop rsaeftbnyt (kgzmdvxwfx )	-	20 May 2013
NCT00101166 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant	43	Bystander-Based Autologous Tumor Cell Vaccine	ptaaqszxtc(jacnrwlssv) = vefhjfminj fktoigmsis (kgetpmuxxh, dnfalnidah - kdpuzpezcl) View more	-	16 Nov 2012