"ImmunoBreast - A Phase Ib Study to Investigate the Safety, Tolerability and Trends of Efficacy of ALECSAT Treatment as an add-on Therapy to Carboplatin and Gemcitabine in Patients With Locally Advanced or Metastatic Triple-negative Breast Cancer"

A phase Ib study to investigate the safety, tolerability and trends of efficacy of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer.

Start Date21 Apr 2020

Sponsor / Collaborator

Odense University Hospital

[+1]

EUCTR2019-001420-34-DK

/ Unknown statusPhase 2IIT

ImmunoBreast - A phase II study to investigate the efficacy and safety of ALECSAT treatment as an add-on therapy to carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer”

Start Date01 Nov 2019

Sponsor / Collaborator-

NCT02799238

/ CompletedPhase 2

An Open Label, Randomised, Phase II Study to Investigate the Efficacy and Safety of ALECSAT Treatment as an add-on Therapy to Radiotherapy and Temozolomide in Patients With Newly Diagnosed Glioblastoma

This is a randomised, open-label, multi-centre, Phase II study in patients with newly diagnosed glioblastoma.
62 patients with newly diagnosed glioblastoma are enrolled in the study in a 1:2 allocation (standard of care (SOC): ALECSAT as an adjunct therapy to SOC).
Patients recruited into this study will receive either:
* ALECSAT as an adjunct therapy to standard of care for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion) or
* Standard of care therapy for newly diagnosed glioblastoma (first line therapy: Stupp regimen, followed by second line therapy at the Investigator's discretion).

Start Date01 Mar 2016

Sponsor / Collaborator

CytoVac AS

100 Clinical Results associated with Alecsat (Cytovac)

100 Translational Medicine associated with Alecsat (Cytovac)

100 Patents (Medical) associated with Alecsat (Cytovac)

Literatures (Medical) associated with Alecsat (Cytovac)

01 Dec 2025·Journal for ImmunoTherapy of Cancer

Adoptive cell transfer therapy with ex vivo primed peripheral lymphocytes in combination with chemotherapy in locally advanced or metastatic triple-negative breast cancer: the ImmunoBreast phase Ib clinical trial

Article

Author: Ditzel, Henrik J ; Gammelgaard, Odd Lilleng ; Kirkin, Alexei F ; Kodahl, Annette Raskov ; Sandberg, Lene ; Jylling, Anne Marie Bak ; Ehmsen, Sidse

Background:

Adoptive cell transfer-based immunotherapy holds promise for treating advanced cancer. However, a key challenge remains: generating sufficient numbers of lymphocytes capable of recognizing and targeting a broad range of cancer antigens. We recently developed Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT), a novel procedure for selecting, expanding and maturing polyclonal lymphocytes from peripheral blood with the capacity to target cancer cells. In this single-center phase Ib trial, we evaluated the safety, tolerability, and preliminary efficacy of ALECSAT in combination with standard carboplatin and gemcitabine in patients with locally advanced or metastatic triple-negative breast cancer (mTNBC).

Methods:

This clinical study enrolled 15 patients with mTNBC. The patients received three ALECSAT doses, administered every 28 days. Subsequently, ALECSAT doses were given at 6-week intervals. Carboplatin and gemcitabine were administered on days 1 and 8 in 3-week cycles. The cell composition of ALECSAT preparations was analyzed using flow cytometry. Additionally, patient-derived xenograft (PDX) mouse models were generated and treated with ALECSAT to assess treatment responses.

Results:

14 patients with mTNBC, who had received one to four prior treatment lines, were treated with 1–10 doses of ALECSAT. The combination of ALECSAT with carboplatin and gemcitabine was well tolerated and demonstrated a favorable safety profile. Common adverse events (AEs), including fatigue, nausea, and hematological abnormalities, were consistent with the known toxicity profiles of carboplatin and gemcitabine. Notably, grade ≥3 AEs were predominantly hematological, with manageable durations of neutropenia and thrombocytopenia. Among treated patients, one achieved a complete response, four had partial responses, five had stable disease, and four had progressive disease. The objective response rate was 36% (95% CI 12.8% to 64.9%). Median progression-free survival was 4.3 months (95% CI 1.6 to 7.0), while median overall survival was 8.7 months (95% CI 5.1 to 12.4). A positive correlation was observed between the total number of administered ALECSAT cells (particularly CD8+T cells) and time to progression. Additionally, ALECSAT treatment outcomes in patients correlated with responses observed in their corresponding PDX models.

Conclusion:

ALECSAT, in combination with carboplatin and gemcitabine, was safe, well tolerated, and demonstrated promising antitumor activity in mTNBC. These findings support further investigation in larger clinical trials.

Trial registration number:

NCT00891345 .

01 Jan 2021·Neuro-oncology advances

A randomized phase II trial of efficacy and safety of the immunotherapy ALECSAT as an adjunct to radiotherapy and temozolomide for newly diagnosed glioblastoma

Article

Author: Rydenhag, Bertil ; Dzhandzhugazyan, Karine N ; Strandeus, Michael ; Raida, Martin K ; Blomstrand, Malin ; Smits, Anja ; Werlenius, Katja ; Jakola, Asgeir S ; Kirkin, Alexei F ; Carén, Helena ; Stragliotto, Giuseppe ; Kinhult, Sara ; Dyregaard, Dorte

Abstract:

Background:

There is an urgent need for effective treatments against glioblastoma (GBM). In this trial, we investigated the efficacy and safety of an adoptive cell-based immunotherapy.

Methods:

Patients with newly diagnosed GBM were recruited at 4 study sites in Sweden. The patients were randomized 1:2 to receive either radiotherapy (RT), 60 Gy/30 fractions, with concomitant and adjuvant temozolomide (TMZ) only, or RT and TMZ with the addition of Autologous Lymphoid Effector Cells Specific Against Tumor (ALECSAT) in an open-label phase II trial. The primary endpoint was investigator-assessed progression-free survival (PFS). The secondary endpoints were survival and safety of ALECSAT.

Results:

Sixty-two patients were randomized to either standard of care (SOC) with RT and TMZ alone (n = 22) or SOC with ALECSAT (n = 40). Median age was 57 years (range 38–69), 95% of the patients were in good performance status (WHO 0–1). There was no significant difference between the study arms (SOC vs ALECSAT + SOC) in PFS (7.9 vs 7.8 months; hazard ratio [HR] 1.28; 95% confidence interval [CI] 0.70–2.36; P = .42) or in median overall survival (OS) (18.3 vs 19.2 months; HR 1.16, 95% CI 0.58–2.31; P = .67). The treatment groups were balanced in terms of serious adverse events (52.4% vs 52.5%), but adverse events ≥grade 3 were more common in the experimental arm (81.0% vs 92.5%).

Conclusion:

Addition of ALECSAT immunotherapy to standard treatment with radiochemotherapy was well tolerated but did not improve PFS or OS for patients with newly diagnosed GBM.

01 Jan 2018·Neoplasia (New York, N.Y.)Q2 · MEDICINE

Determinants for Effective ALECSAT Immunotherapy Treatment on Autologous Patient-Derived Glioblastoma Stem Cells

Q2 · MEDICINE

ArticleOA

Author: Wenger, Anna ; Rydenhag, Bertil ; Werlenius, Katja ; Farahmand, Dan ; Thorén, Fredrik Bergh ; Smits, Anja ; Jakola, Asgeir S ; Hallner, Alexander ; Carén, Helena ; Tisell, Magnus

Glioblastoma (GBM) is the most aggressive primary brain tumor with a median survival of less than 15 months, emphasizing the need for better treatments. Immunotherapy as a treatment for improving or aiding the patient's own immune defense to target the tumor has been suggested for GBM. A randomized clinical trial of adoptive cell transfer using ALECSAT (Autologous Lymphoid Effector Cells Specific Against Tumor Cells) is currently ongoing in Sweden. Here we performed a paired pre-clinical study to investigate the composition and in vitro effect of ALECSAT and identify determinants for the effect using autologous GBM-derived cancer stem cells (CSC), immunocytochemistry and flow cytometry. We show a clear dose-response relationship of ALECSAT on CSC, suggesting that the number of infused cells is of importance. In addition, the in vitro effect of ALECSAT on CSC correlated significantly to the blood count of T helper (T_h) cells in the patient indicating a potential benefit of collecting cells for ALECSAT preparation at an even earlier stage when patients generally have a better blood count. The factors identified in this study will be important to consider in the design of future immunotherapy trials to achieve prolonged survival.

News (Medical) associated with Alecsat (Cytovac)

14 Jan 2020

·cytovac.com

Pressemeddelelse/ Press release 14. jan 2020

På dansk – in English below Pressemeddelse Cytovac Jan. 14, 2020 Cytovac har igangsat en ny privat kapital rejsning i perioden d. 14-31 Januar, hvor selskabet ønsker at rejse 15 millioner danske kroner (SEK 21.5 millioner), der skal finansiere selskabets aktiviteter indtil udgangen af 2020. Cytovac har besluttet at starte et investigator-initieret studie i triple negativ brystkræft (CV007) i samarbejde med Odense Universitets Hospital. Studiet forventes påbegyndt senere i 2020. Til dette studie vil CytoVacs 2nd generations Alecsat produkt blive benyttet. CytoVac følger hermed sin tidligere oplyste kliniske udviklingsplan. Cytovac har afsluttet CV006 fase 2 studiet i patienter med hjernekræft (glioblastom) i Sverige. Studiet inkluderede 62 patienter randomiseret 1:2 til at modtage standard behandling eller standard behandling plus ALECSAT behandling. Det primære formål med studiet var at undersøge effekten af ALECSAT på udvikling af glioblastom. Fase 2 studiet viste ingen statistisk signifikant effekt af ALECSAT behandlingen på udviklingen af glioblastom. CytoVacs CV003 fase 1 studie (25 patienter med glioblastom) demonstrerede ellers 2 patienter med komplet respons og en patientmed delvis respons. Selskabets direktør, Kim Arvid Nielsen, har besluttet ikke at være en del af den fremtidige udvikling hos CytoVac, men har valgt at stå til rådighed for selskabet i en fremadrettet periode. Selskabets finanschef, Lone Dahl Andersen, bliver konstitueret som ny direktør for selskabet foreløbigt frem til 1. marts 2020. Bestyrelsen In English Press release Cytovac January 14, 2020 Cytovac has initiated a new private capital raise for the period January 14-31, 2020, Cytovac wishes to raise DKK 15 million (SEK 21.5 million), which will finance the company´s activities until the end of 2020. Cytovac has decided to start the investigator-initiated study in triple negative breast cancer (CV007) in collaboration with Odense University hospital. The study is expected to start later in 2020. For this study Cytovac´s 2nd generation ALECSAT product will be used. Thus, Cytovac continues its previously announced clinical development plan. Cytovac has completed the CV006 phase 2 study in patients with brain cancer (glioblastoma) in Sweden. The study included 62 patients randomized 1:2 to receive standard treatment or standard treatment plus ALECSAT therapy. The primary objective of the study was to investigate the effect of ALECSAT on glioblastoma progression. The phase 2 study showed no statistically significant effect of ALECSAT therapy on the progression of glioblastoma. Cytovac´s CV003 phase 1 study (25 patients with advanced glioblastoma) otherwise demonstrated 2 patients with complete response and one patient with partial response. The company´s CEO Kim Arvid Nielsen has decided not to be a part of the future development at Cytovac but has chosen to be available to the company for a future period. The company´s CFO, Lone Dahl Andersen will be appointed as new CEO of the company provisionally until March 1, 2020. Board of Directors

Phase 2Clinical ResultExecutive ChangePhase 1

100 Deals associated with Alecsat (Cytovac)

R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Metastatic breast cancer	Phase 2	Denmark	CytoVac AS	21 Apr 2020
Triple Negative Breast Cancer	Phase 2	Denmark	CytoVac AS	21 Apr 2020
Glioblastoma Multiforme	Phase 2	Denmark	CytoVac AS	01 Feb 2014
Locally Advanced Pancreatic Adenocarcinoma	Phase 1	Denmark	CytoVac AS	01 Oct 2013
Castration-Resistant Prostatic Cancer	Phase 1	Denmark	CytoVac AS	01 Apr 2009

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