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This is a trial of AGS-003, which is being studied as a possible treatment for Advanced Renal Cell Carcinoma. The purpose of this study is to determine whether there is an overall survival (OS) benefit between subjects treated with AGS-003 in combination with standard treatment versus subjects treated with standard treatment alone.

Start Date01 Nov 2012

Sponsor / Collaborator

Argos Therapeutics, Inc.

NCT01482949 / TerminatedPhase 2

A Rollover Phase II Study Testing the Biologic Activity and Safety of AGS-003 in Renal Cell Carcinoma Subjects With Prolonged Response or Stable Disease and Ongoing AGS-003 Treatment in Protocol AGS-003-004 or AGS-003-006

The purpose of this study is to evaluate clinical response to AGS-003 alone or in combination with sunitinib therapy.

Start Date01 Sep 2011

Sponsor / Collaborator

Argos Therapeutics, Inc.

100 Clinical Results associated with Rocapuldencel-T

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100 Translational Medicine associated with Rocapuldencel-T

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100 Patents (Medical) associated with Rocapuldencel-T

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14

Literatures (Medical) associated with Rocapuldencel-T

01 Aug 2023·Human Vaccines & Immunotherapeutics

A review of the clinical experience with CMN-001, a tumor RNA loaded dendritic cell immunotherapy for the treatment of metastatic renal cell carcinoma

Review

Author: Horvatinovich, Joe ; DeBenedette, Mark ; Gamble, Alicia ; Nicolette, Charles A ; Norris, Marcus

Engineering dendritic cells (DCs) to treat cancer is a long sought-after goal for cell-based immunotherapies. In this review, we focus on the experience with CMN-001, formally AGS-003, a DC-based immunotherapy, employing autologous DC electroporated with autologous tumor RNA to treat subjects with metastatic renal cell carcinoma (mRCC). We will review the early clinical development of CMN-001 up to and including deployment in a multicenter phase 3 study and provide a rationale to continue the development of CMN-001 in an ongoing randomized phase 2 study. The synergy between CMN-001 and everolimus observed in the phase 3 study provides an opportunity to design a phase 2b study building on the mechanism of action of CMN-001 and underlying immune and clinical outcomes revealed in the earlier studies. The design of the phase 2b study combines CMN-001 with first-line checkpoint inhibition therapy and second line lenvatinib/everolimus in poor-risk mRCC subjects.

15 May 2020·Clinical Cancer ResearchQ1 · MEDICINE

Results of the ADAPT Phase 3 Study of Rocapuldencel-T in Combination with Sunitinib as First-Line Therapy in Patients with Metastatic Renal Cell Carcinoma

Q1 · MEDICINE

Article

Author: Bratslavsky, Gennady ; Plachco, Ana ; Vaena, Daniel ; Norris, Marcus S. ; Master, Viraj ; Wood, Christopher G. ; Kapoor, Anil ; Nicolette, Charles A. ; Figlin, Robert A. ; Tannir, Nizar M. ; Chen, David Y.T. ; DeBenedette, Mark ; Tcherepanova, Irina Y. ; Lowrance, William ; Horvatinovich, Joe ; Uzzo, Robert G. ; Gamble, Alicia ; Tykodi, Scott S.

AbstractPurpose:Rocapuldencel-T is an autologous immunotherapy prepared from mature monocyte-derived dendritic cells (DC), coelectroporated with amplified tumor RNA plus CD40L RNA. This pivotal phase III trial was initiated to investigate the safety and efficacy of a combination therapy dosing regimen of Rocapuldencel-T plus sunitinib in patients with metastatic renal cell carcinoma (mRCC).Patients and Methods:Patients received either Rocapuldencel-T plus standard of care (SOC) or SOC treatment alone. The primary objective compared overall survival (OS) between groups. Secondary objectives included safety assessments, progression-free survival (PFS), and tumor responses based on RECIST 1.1 criteria. Exploratory analyses included immunologic assessments and correlates with OS.Results:Between 2013 and 2016, 462 patients were randomized 2:1, 307 to the combination group and 155 to the SOC group. Median OS in the combination group was 27.7 months [95% confidence interval (CI) 23.0–35.9] and 32.4 months (95% CI, 22.5–) in the SOC group HR of 1.10 (95% CI, 0.83–1.40). PFS was 6.0 months and 7.83 months for the combination and SOC groups, respectively [HR = 1.15 (95% CI, 0.92–1.44)]. The ORR was 42.7% (95% CI, 37.1–48.4) for the combination group and 39.4% (95% CI, 31.6–47.5) for the SOC group. Median follow up was 29 months (0.4–47.7 months). On the basis of the lack of clinical efficacy, the ADAPT trial was terminated on February 17, 2017. Immune responses were detected in 70% of patients treated with Rocapuldencel-T, and the magnitude of the immune response positively correlated with OS. In addition, we report the survival-predictive value of measuring IL-12 produced by the DC vaccine and the observation that high baseline numbers of T regulatory cells are associated with improved outcomes in DC-treated patients, but are associated with poor outcomes in patients receiving SOC treatment. No serious adverse events attributed to the study medication have been reported to date.Conclusions:Rocapuldencel-T did not improve OS in patients treated with combination therapy, although the induced immune response correlated with OS. Moreover, we identified two potential survival-predictive biomarkers for patients receiving DC based immunotherapy, IL-12 produced by the DC vaccine and higher numbers of T regulatory cells present in the peripheral blood of patients with advanced RCC.

01 Jan 2018·AIDS Research and Human RetrovirusesQ4 · MEDICINE

Immunogenicity of AGS-004 Dendritic Cell Therapy in Patients Treated During Acute HIV Infection

Q4 · MEDICINE

Article

Author: Tcherepanova, Irina Y. ; McGee, Kara S. ; Eron, Joseph J. ; Gamble, Alicia ; Gay, Cynthia L. ; Kearney, Mary F. ; DeBenedette, Mark A. ; Margolis, David M. ; Cope, Anna B. ; Archin, Nancie M. ; Nicolette, Charles A. ; Coffin, John M. ; Lewis, Whitney E. ; Hicks, Charles B. ; Kuruc, JoAnn D.

AGS-004 consists of matured autologous dendritic cells co-electroporated with in vitro transcribed RNA encoding autologous HIV antigens. In an open-label, single arm sub-study of AGS-004-003, AGS-004 was administered monthly to suppressed participants who started antiretroviral therapy (ART) during acute HIV infection. HIV-1 specific T cell responses were measured by multicolor flow cytometry after 3-4 doses. The frequency of resting CD4⁺ T-cell infection (RCI) was measured by quantitative viral outgrowth assay. Participants demonstrating increased immune response postvaccination were eligible for analytic treatment interruption (ATI). AGS-004 induced a positive immune response defined as ≥2-fold increase from baseline in the number of multifunctional HIV-1 specific CD28⁺/CD45RA^- CD8⁺ effector/memory cytoxic T-lymphocytes (CTLs) in all six participants. All participants underwent ATI with rebound viremia at a median of 29 days. Immune correlates between time to viral rebound and the induction of effector CTLs were determined. Baseline RCI was low in most participants (0.043-0.767 IUPM). One participant had a >2-fold decrease (0.179-0.067 infectious units per million [IUPM]) in RCI at week 10. One participant with the lowest RCI had the longest ATI. AGS-004 dendritic cell administration increased multifunctional HIV-specific CD28⁺/CD45RA^- CD8⁺ memory T cell responses in all participants, but did not permit sustained ART interruption. However, greater expansion of CD28^-/CCR7^-/CD45RA^- CD8⁺ effector T cell responses correlated with a longer time to viral rebound. AGS-004 may be a useful tool to augment immune responses in the setting of latency reversal and eradication strategies.

100 Deals associated with Rocapuldencel-T

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R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic Renal Cell Carcinoma	Phase 3	US	Argos Therapeutics, Inc.	30 Jan 2022
Non-Small Cell Lung Cancer	Phase 2	US	GU Research Network, LLC	01 Mar 2016
Advanced Renal Cell Carcinoma	Phase 2	CA	Argos Therapeutics, Inc.	01 Jan 2008
Advanced Renal Cell Carcinoma	Phase 2	US	Argos Therapeutics, Inc.	01 Jan 2008

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Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT01582672 (ADAPT, ASCO2018)	Phase 3	Metastatic Renal Cell Carcinoma \| Advanced Renal Cell Carcinoma	462	Rocapuldencel-T + sunitinib	(oekriizbpf) = ldimgrzjwg epinotzhax (velrttnrdt )	-	01 Jun 2018
NCT01582672 (ADAPT, ASCO2018)	Phase 3		462	Standard-of-care + sunitinib	(oekriizbpf) = ulwiznvgij epinotzhax (velrttnrdt )	-	01 Jun 2018
NCT01582672 (ADAPT Trial, SITC2017)	Phase 3	Metastatic Renal Cell Carcinoma CD28+/CD45RA- \| IL-12	146	Rocapuldencel-T + standard-of-care (SOC)	qiflwcbomq(tiwetbjbxr) = xueoztazkh vlujvdpvif (tgzthmejqz )	Positive	07 Nov 2017
NCT01582672 (ADAPT Trial, SITC2017)	Phase 3	Metastatic Renal Cell Carcinoma CD28+/CD45RA- \| IL-12	146	Standard-of-care (SOC) alone	qiflwcbomq(tiwetbjbxr) = knjjvghuue vlujvdpvif (tgzthmejqz )	Positive	07 Nov 2017
ADAPT \| P217 (SITC2016)	Phase 3	-	-	AGS-003	pmtlacbpsi(ygxgkbxejt) = xsaylgpfxo nfvajomaqz (oxfnulnzrn )	Positive	16 Nov 2016
ADAPT \| P217 (SITC2016)	Phase 3	-	-	PD-1 checkpoint inhibitor	pmtlacbpsi(ygxgkbxejt) = zozwquwqjn nfvajomaqz (oxfnulnzrn )	Positive	16 Nov 2016
NCT00678119 (Pubmed \| J Immunother Cancer) Manual	Phase 2	Advanced Renal Cell Carcinoma	21	sunitinib+AGS-003	(uaqqfqxpzv) = jvrykmwzlb zezprguuxa (urslxmpepx ) View more	Positive	21 Apr 2015
NCT00678119 (ASCO_GU2013)	Phase 2	Metastatic Renal Cell Carcinoma	21	AGS-003 plus sunitinibAGS-003 plus sunitinib	(dcybhyyscb) = fxnuuwyauo texagsvhwo (lyuxjedlkp ) View more	-	20 Feb 2013
AGS-003-006 (ASCO_GU2012)	Phase 2	Metastatic Renal Cell Carcinoma	25	AGS-003	(tnenkljwxz) = qipxfrypgg gklbtfwrwv (adxiufdmgq ) View more	-	10 Feb 2012