Neoplasms

All Conditions

Rare Diseases

Glioblastoma

Astrocytoma

Glioma

Neoplasms, Neuroepithelial

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

Neoplasms, Nerve Tissue

Neuroepithelioma

Antineoplastic Agents

All Drugs and Chemicals

Temozolomide

Immunomodulating Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

radiotherapy combined with TMZ treatment followed by adjuvant TMZ

3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months

3 doses of ALECSAT/4 weeks followed by ALECSAT/3 months

ALECSAT

Radiotherapy

Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks

Katja Werlenius, PhD

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).

Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma

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

Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC

To compare OS rate at 12 and 24 months between patients who receive ALECSAT as add on to SoC and patients who only receive SoC

Comparison of frequency and severity of treatment related AEs in the 2 study groups

CytoVac A/S

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Hormones

Autologous activated CTL and NK-cells injected as a single intravenous injection.

Hans-Henrik Meyhoff, MD

This study is a phase I study of a new cell based prostate cancer therapy (ALECSAT). In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumour cells and in this way stop or slow down the progression of disease.

This study is a prospective open phase I study to investigate the safety and tolerability of administration of a single dose of a cell based medicinal product (CBMP) ALECSAT.

ALECSAT is an autologous CBMP that is made from the patient's own blood cells. ALECSAT contains a large amount of tumour specific cytotoxic Lymphocytes (CTL) and Natural Killer (NK) cells that are isolated activated and amplified in number.

The CBMP is given as a slow i. v. injection to patients with prostate cancer. The patients are in the late stage of the disease where they have received hormone treatment but their disease is progressing.

The primary objective of the study is to observe if any side effects or tolerability issues occur as a consequence of the cell administration, secondarily it will be observed if any positive anti tumour effect may be observed. The study has the purpose to investigate whether treatment with ALECSAT in any way is toxic.

Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate cancer patients.

A group consisting of 6 patients will be treated with ALECSAT according to the protocol. Then an interim analysis will be done. If there are no signs of significant toxicity related to the treatment, the study will continue with 8 more patients that will be included and treated with ALECSAT according to the phase I protocol. Thus this study will include a total of 14 patients.

The patients will after a single administration of ALECSAT be hospitalised for 3 days and will furthermore be followed closely for 7 weeks by 5 planned study visits, by the investigators at Urologisk Klinik at Fredrikssund Hospital.

Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy

A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Prostate Cancer Patients - a First Dose in Man Study

Autologous activated CTL and NK-cells injected as three intravenous injections interspaced by 5 weeks.

This study is a phase I study of a cell based prostate cancer therapy, Autologous Lymphoid Effector Cells Specific Against Tumor-cells (ALECSAT). Safety and tolerability of a single dose has been shown in 13 prostate cancer patients. In this study 20 prostate cancer patients will receive 3 doses of the ALECSAT treatment. In this therapy specific cells from the patient's own immune system are isolated, activated and re-administered to the patient to boost a specific immune response against the cancer cells. The aim of the study is to show safety and tolerability for repeated dosing of this type of therapy. It is the hypothesis that the cells administered during the therapy will attack the tumor cells and in this way stop or slow down the progression of disease.

This study is a prospective open phase I study to investigate the safety and tolerability of administration of repeated doses of a cell based medicinal product (CBMP) ALECSAT.

ALECSAT is an autologous CBMP that is made from the patient's own blood cells. ALECSAT contains a large amount of tumour specific cytotoxic Lymphocytes (CTL) and Natural Killer (NK) cells that are isolated activated and amplified in number.

The CBMP is given as a slow i. v. injection to patients with prostate cancer. The patients are in the late stage of the disease where they have received hormone treatment but their disease is progressing.

The primary objective of the study is to observe if any side effects or tolerability issues occur as a consequence of the repeated administration of ALECSAT, secondarily it will be observed if changes in Prostate-Specific Antigen (PSA) levels or any positive anti tumor effect may be observed. The study has the purpose to investigate whether repeated treatment with ALECSAT in any way is toxic.

Trial Design: The study is an open, prospective phase I safety study of ALECSAT in prostate cancer patients.

A group consisting of 4 patients will be treated twice with ALECSAT according to the protocol. Then an interim analysis will be done. If there are no signs of significant toxicity related to the treatment, the study will continue to the third treatment for these patients and with 14 more patients that will be treated with ALECSAT according to the protocol. Thus this study will include a total of 20 patients.

The patients will after the first administration of ALECSAT be hospitalized for 2 days. Five and 10 weeks later the patients will be hospitalized for 1 day and receive the second and third administration of ALECSAT. Each patient will furthermore be followed closely for 12 weeks after the third treatment. During the course of the entire study the patients will be monitored by 11 planned study visits, by the investigators at Department of Urology, Fredrikssund Hospital, Denmark.

Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy

A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering Repeated Doses of ALECSAT to Prostate Cancer Patients.

To show safety and tolerability patients was monitored closely after administration of ALECSAT and during the follow up period. Heart rate, temperature, blood pressure, Performance status was monitored. Blood samples analysed were: PSA, Alkaline Phosphatase (ALP), Lactate DeHydogenase (LDH), Creatinine (CREAT) and Standard haematology: Blood picture (complete blood count, haemogram), leucocytes, Differential count, electrolytes, renal function, and liver count (liver enzymes).

AE and SAE was reported during the study period and the Investigator was urged to judge whether the event was related to the study product or not.

Blood pressure, pulse and temperature were monitored frequently during 48 hours post injection of the study product, and thereafter at each follow up visit.

No significant conclusion of efficacy is possible due to the study design with only one group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy, defined as stable disease or partial response, are possible. Trends towards possible treatment response were measured by monitoring PSA, a potential marker for prostate cancer disease progression; by other blood markers; and by Quality of life questionnaire (EORTC QLQ-C30) and WHO/ECOG (Eastern Cooperative Oncology Group). Control of any bone metastases were followed by hotspots and bone scan index measured by skeletal scintigraphy.

At each visit, the physician must assess whether any adverse events/reactions or side effects have occurred. Such events may either be reported by the subjects, be observed at the visits or discovered by the laboratory tests.

Age, Categorical

Mean age

Age, Continuous

Sex: Female, Male

Denmark

Region of Enrollment

Christer Lundell-Ek, Project Manager - Clinical Development

Total numbers of Adverse Events (AE)

AE judged as related to study product

Number of Serious Adverse Events (SAE)

SAE judged as related to study product

Safety issues identified by EORTC

ALCESAT

No formal statistical analysis plan was considered for this study. Any subject that received one administration of ALECSAT and a 6 week follow-up period will be considered as having received ALECSAT and be included in the efficacy part of the report. All patients that received at least one injection of ALECSAT was assessed for safety.

Adverse Events

Trends towards possible treatment response

No trends of possible treatment response

Not evaluable patients

No significant conclusion of efficacy is possible due to the study design with only one active group of patients. However by analyzing and comparing the outcome with the data the individual patient presented at baseline some trends of efficacy are possible. Scintigraphy and blood tests (PSA, ALP, LDH and Creatinine)were used for this analysis.

Trends Towards Possible Treatment Response

The Secondary Endpoint for This Study is to Establish if Any Indications of a Positive Therapeutic Effect on the Prostate Cancer May be Observed.

Significant abnormal changes in Blood pressure

Significant abnormal changes in Pulse

Significant abnormal changes in temperature

Blood Pressure, Pulse and Temperature

After inclusion in the ALECSAT trial, the subject donates 200 ml blood sample for the first ALECSAT product, and after 6 and 11 weeks the subject donated 200 ml again for the second and third product. ALECSAT was thereafter administered at week 4, 9, and week 14.

Overall Study

Digestive System Diseases

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Endocrine Gland Neoplasms

Gastrointestinal Diseases

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Gastrointestinal Agents

Pancrelipase

Pancreatin

The ALECSAT CBMP will be administered as single dose at week 4, 7 and week 10 which is considered an appropriate time for ALECSAT CBMP to strengthen the immune system and thus have the ability to kill tumour cells. It is the aim that the patients will receive three doses during the study period however, if the patient wish and it is recommended by the investigator, patients may receive more than three doses, continuing until progression or as judged by the Investigator. Continued treatment after the 24 week study period is only possible under the condition that no safety issues have been discovered. The interval between injections for continued treatment will be decided based on e.g. tumour response and clinical examinations.

Alecsat

Lars T. Sørensen, MD

This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.

Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.

This study is a prospective open phase-I study to investigate the safety and tolerability for administration of repeated doses of ALECSAT.

Each patient will be followed up to 24 weeks from the initial blood donation to the last visit. However, the actual treatment starts on day 26, when the first single dose of ALECSAT is administered. The following administrations are given with 3 weeks intervals, i.e. at week 7 and 10. The patients are attending Kirurgisk afdeling K, Bispebjerg Hospital, and are followed by close examinations during the study period and at regular visits after completing the study as advised by the patient's responsible physician.

The selected group of patients suffers from locally advanced pancreatic cancer and have been treated with first line treatment regimens (e.g. surgery, radiotherapy, and/or Folfirinox) and are followed at Kirurgisk afdeling K, Bispebjerg Hospital. The subjects will be recruited consecutively and included to the study if they fulfil the inclusion criteria and do not meet any of the exclusion criteria. Potential candidates will receive oral information by the Investigator subsequent to the written patient information. The potential candidate must have the opportunity to consider the given information and to further ask the Investigator questions before finally deciding to participate. When the patient decides to take part in the study he/she will be required to sign the declaration of consent.

A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients

A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of Administering ALECSAT to Pancreas Cancer Patients

Changes in pancreatic cancer marker CA19-9, change in Haemoglobin, Lymphocytes and their subpopulations, Leucocytes, ASAT, ALAT, Amylase, Bilirubin, Glucose, LDH, Sodium and Potassium that may show trends of clinical effect at specific time points and will be compared with the individual patients status at baseline,

Changes in the patients quality of life and performance status are measured at specific time points and will be compared with the individual patients status at baseline,

Investigation of the safety and tolerability of administrating repeated doses of ALECSAT will be measured by recording the presence of adverse events/serious adverse events during the study period, and by following clinically significant changes in blood parameters, performance status and quality of life questionnaire at specific time points and compare with the individual patients status at baseline

Assessment of any change in tumour involvement are followed by CT (according to the RECIST 11 protocol) at specific time points and will be compared with the individual patients status at baseline

Skin and Connective Tissue Diseases

Breast Neoplasms

Triple Negative Breast Neoplasms

Breast Diseases

Skin Diseases

Gemcitabine

Carboplatin

This is an exploratory single arm study. 20 patients will be included with the objective to investigate the safety, tolerability and trends of efficacy of ALECSAT for the treatment of recurrent TNBC.

ALECSAT is a form of adoptive cell therapy medicinal product. ALECSAT is an abbreviation for Autologous Lymphoid Effector Cells Specific Against Tumor. ALECSAT is an autologous product that induces an immune response against a broad repertoire of CTAs expressed on cancer cells (including TNBC) leading to killing of these cells.

Patients will receive standard treatment with carboplatin and gemcitabine along with ALECSAT.

Patients will receive concurrent chemotherapy with carboplatin/gemcitabine with cycles repeated every 3 weeks.

During the loading phase, patients will receive ALECSAT at 28 days intervals at weeks 5, 9, and 13. Hereafter (the maintenance phase), ALECSAT will be administered every 12 weeks until disease progression, death, unacceptable toxicity, investigator/patient decision or EOT visit at 18 months.

Henrik J Ditzel, MD, PhD

Annette R Kodahl, M.D.

Henrik J Ditzel, M.D.

Erik H Jakobsen, M.D.

Anette R Kodahl, MD, PhD

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.

This is a phase Ib, dual-center, open-label, single-arm, clinical study to determine the safety, tolerability and trends of efficacy of ALECSAT as an add-on therapy to standard treatment with carboplatin and gemcitabine in female patients with locally advanced inoperable or metastatic TNBC, which has received no more than two prior systemic therapies for mTNBC.

Study treatments will continue until any of the following occurs: disease progression is locally verified using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST 1.1); unacceptable toxicity; intercurrent illness that necessitates discontinuation of study treatment; Investigator's decision to withdraw the patient; pregnancy; patient noncompliance with study treatment or procedure requirements; withdrawal of consent to treatment; death; end-of-treatment visit at month 18; or other administrative reasons requiring cessation of study treatment. If chemotherapy is discontinued during the study, the patient will be allowed to continue in the study on ALECSAT treatment after discontinuation of chemotherapy, based on the Investigator's judgement. In addition, if clinical assessments indicate an anti-cancer effect of ALECSAT treatment (at the discretion of the investigator) at end of study, patients will be offered to continue ALECSAT treatment after end of the study under approved named patient use. Response assessment according to RECIST v1.1 will be performed at weeks 9 (±7 days), 18 (±7 days), and 27 (±7 days) after treatment start as by local hospital standards. Imaging will continue every 9 weeks (±7 days) thereafter during the first year, independent of any treatment delays. Response assessment will be performed every 12 weeks (±7 days) after the first year. Safety will be monitored according to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 (v5.0). Patients who discontinue study treatments for reasons other than PD will continue post-treatment imaging studies for disease status follow-up as per protocol, i.e., every 9 weeks (± 7 days) and 12 weeks (± 7 days) during the first year or second year of study participation, until disease progression, start of a non-study anticancer treatment, withdrawal of consent to study participation, death, or end-of-treatment visit 18 months.

ImmunoBreast - A Phase Ib Study

"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"

PFS according to RECIST v1.1, from the initiation of study treatment to the time of radiographic progression or death from any cause during the study.

DCR according to RECIST v1.1 defined as the proportion of patients with CR, PR or stable disease (SD).

DOR according to RECIST v1.1 defined as the time from the first occurrence of a documented objective tumor response to the time of radiographic progression or death from any cause on study, whichever occurs first.

OS defined as the time from initiation of study treatment to the date of death from any cause.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S
Safety Study of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy	NCT00891345	Hormone-refract...	ALECSAT	18 Years -	CytoVac A/S
Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma	NCT02799238	Glioblastoma	ALECSAT Radiotherapy Temozolomide	18 Years - 70 Years	CytoVac A/S
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy	NCT01422850	Hormone-refract...	ALECSAT	18 Years -	CytoVac A/S
Safety Study of Repeated Dosing of a Cytotoxic Lymphocytes (CTL) Based Prostate Cancer Therapy	NCT01422850	Hormone-refract...	ALECSAT	18 Years -	CytoVac A/S
A Prospective, Open Phase I Study to Investigate the Tolerability and Efficacy of ALECSAT to Pancreas Cancer Patients	NCT01984658	Pancreatic Canc...	Alecsat	18 Years -	CytoVac A/S
ImmunoBreast - A Phase Ib Study	NCT04609215	Triple Negative... Breast Cancer Metastatic Brea...	ALECSAT	18 Years -	Odense University Hospital

Spots Global Cancer Trial Database for alecsat

Every month we try and update this database with for alecsat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for alecsat

Every month we try and update this database with for alecsat cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for alecsat cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.