An open-label, randomised, Phase II study to investigate the efficacy andsafety of Autologous Lymphoid Effector Cells Specific Against Tumour-Cells(ALECSAT) treatment as an add-on therapy to radiotherapy andtemozolomide (standard of care) in patients with newly diagnosedglioblastoma (malignant primary brain tumor)

Phase 1

• Conditions: Glioblastoma multiforme; MedDRA version: 20.0Level: PTClassification code 10018337Term: Glioblastoma multiformeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-004058-17-SE
• Lead Sponsor: CytoVac A/S

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12-09
• Last Update Posted: 14 May 2018

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

1. Male or female patients, aged between 18 and 70.
2. Histologically confirmed, newly diagnosed glioblastoma, including
gliosarcoma.
3. Eligible for combined radiotherapy and TMZ treatment. (Stupp
treatment)
4. Patients with complete or partial tumour resection. For patients
with limited tumour volume, biopsy is acceptable.
5. WHO Performance status 0-2.
6. Body weight 40 = kg (males), 50 = kg (females).
7. Able and willing to provide written informed consent and comply
with the study protocol and procedures.
8. Women of child-bearing potential must have a negative pregnancy
test at screening and agree to use acceptable methods of
contraception during the study. A highly effective method of birth
control is defined as those which result in a low failure rate (i.e.
less than 1% per year) when used consistently and correctly such
as implants, injectables, combined oral, intravaginal and
transdermal contraceptives, some intrauterine devices (IUDs),
intrauterine system (IUS), bilateral tubal occlusion, sexual
abstinence or vasectomised partner. True abstinence should be
consistent with the preferred and usual lifestyle of the patient.
Periodic abstinence (e.g. calendar, ovulation, symptothermal, post-
ovulation methods) and withdrawal are not acceptable methods of
contraception.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1. Prior treatment for brain tumours at study entry.
2. Prior treatment with temozolomide at study entry.
3. Females who are pregnant, planning to become pregnant or
breastfeeding.
4. Positive tests for anti- human immunodeficiency virus (HIV)-1/2;
HBsAg, anti HBc, anti-HCV or being positive in a Treponema
Pallidum test (syphilis).
5. Patients who may have been exposed to high risk contagious virus
within a reasonable time prior to enrolment should be excluded,
unless the patient has been tested negative. e.g. by travelling in
areas of the world with known high risk of infection or known
epidemics, (in particular but not limited to West e virus (in
season), Dengue fever, Zika or Ebola when outbreaks are
recognized)
6. 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.
7. Known allergy to study medication.
8. Any condition or illness that, in the opinion of the Investigator,
would compromise patient safety or interfere with the evaluation
of the safety of the investigational drug.
9. Any concurrent illness that may worsen or cause complications in
connection with blood donation, for example uncontrolled
epilepsy, cardiovascular, cerebrovascular or respiratory disease.
10. Use of immunosuppressant drugs with the exception of steroids.
11. Blood transfusion within 48 hours prior to the donation of blood
for ALECSAT production.
12. Low haemoglobin count, in the opinion of the Investigator.
13. Lymphocyte count <0.3 x 10E9 /litre.
14. Receiving any other experimental treatment, including
compassionate use programs and other interventional clinical
studies for glioblastoma, within 30 days prior to inclusion, at the
moment of inclusion or during active treatment within the
assigned group.
15. TMZ contraindication.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified