Clinical Trial Details
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NCT02799238 : Autologuos Lymphoid Effector Cells Specific Against Tumour (ALECSAT) as Add on to Standard of Care in Patients With Glioblastoma
PhasePhase 2
AgesMin: 18 Years Max: 70 Years
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

- TMZ contraindication.
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