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

Study Purpose

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).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years - 70 Years
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Male or female patients, aged between 18 and 70.
  • - Histologically confirmed glioblastoma (Grade IV) diagnosis.
  • - Eligible for combined radiotherapy and TMZ treatment.
  • - Patients with complete or partial tumour resection.
For patients with limited tumour volume, biopsy is acceptable.
  • - WHO Performance status 0-2.
  • - Body weight ≥ 40 kg (males), ≥ 50 kg (females).
  • - Able and willing to provide written informed consent and comply with the study protocol and procedures.
  • - Women of child-bearing potential must have a negative pregnancy test at screening and agree to use acceptable methods of contraception during the trial.

Exclusion Criteria:

  • - Prior treatment for brain tumours at study entry.
  • - Prior treatment with temozolomide at study entry.
  • - Females who are pregnant, planning to become pregnant or breastfeeding.
  • - Positive tests for anti- human immunodeficiency virus (HIV)-1/2; HBsAg, anti HBc, anti-HCV or being positive in a Treponema Pallidum test (syphilis).
  • - Patients who may have been exposed to West Nile virus or Dengue fever virus within the last 28 days prior to enrolment or Ebola virus within the last 60 days prior to enrolment should be excluded, unless the patient has been tested negative.
  • - Patients from high incidence areas for Human T-Lymphotropic Virus (HTLV-1) virus or who has a parent or spouse from a high incidence area must be excluded unless tested negative for HTLV-1 virus.
  • - Known allergy to study medication.
  • - Any condition or illness that, in the opinion of the Investigator or medical monitor, would compromise patient safety or interfere with the evaluation of the safety of the investigational drug.
  • - Any concurrent illness that may worsen or cause complications in connection with blood donation, for example uncontrolled epilepsy, cardiovascular, cerebrovascular or respiratory disease.
  • - Use of immunosuppressant drugs with the exception of steroids.
Blood transfusion within 48 hours prior to the donation of blood for ALECSAT production.
  • - Low haemoglobin count in the opinion of the Investigator.
  • - Lymphocyte count <0.3 x 109/litre.
  • - Participation in any other interventional clinical trial within 30 days prior to inclusion.
  • - TMZ contraindication.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT02799238
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 CytoVac A/S
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Katja Werlenius, PhD
Principal Investigator Affiliation Sahlgrenska University Hospital, Gothenburg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Completed
Countries Sweden
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Glioblastoma
Arms & Interventions

Arms

Active Comparator: Radiotherapy in combination with Temozolomide (TMZ)

radiotherapy combined with TMZ treatment followed by adjuvant TMZ

Experimental: ALECSAT + Radiotherapy in combination with TMZ

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

Interventions

Biological: - ALECSAT

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

Radiation: - Radiotherapy

Radiotherapy 5 days/week for 6 weeks

Drug: - Temozolomide

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Sahlgrenska University Hospital, Göteborg, Sweden

Status

Address

Sahlgrenska University Hospital

Göteborg, ,

Ryhov hospital, Jönköping, Sweden

Status

Address

Ryhov hospital

Jönköping, , 55185

Skånes university hospital, Lund, Sweden

Status

Address

Skånes university hospital

Lund, , 221 85

Karolinska University hospital, Stockholm, Sweden

Status

Address

Karolinska University hospital

Stockholm, , 171 76

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