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

• ClinicalTrials.gov Identifier: NCT02799238
• Recruitment Status: Completed
• First Posted: June 14, 2016
• Last Update Posted: April 30, 2020
• Sponsor: CytoVac A/S
• Information provided by (Responsible Party): CytoVac A/S

Study Description

Brief Summary:

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).

Condition or disease	Intervention/treatment	Phase
Glioblastoma	Biological: ALECSAT; Radiation: Radiotherapy; Drug: Temozolomide	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 62 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: open label
• Primary Purpose: Treatment
• Official Title: 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
• Actual Study Start Date: March 2016
• Actual Primary Completion Date: November 14, 2019
• Actual Study Completion Date: February 24, 2020

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Radiotherapy in combination with Temozolomide (TMZ); radiotherapy combined with TMZ treatment followed by adjuvant TMZ	Radiation: Radiotherapy; Radiotherapy 5 days/week for 6 weeks; Drug: Temozolomide; Temozolomide daily for 6 weeks followed by 6 cycles 5days/4weeks
Experimental: ALECSAT + Radiotherapy in combination with TMZ; 3 doses of ALECSAT /4 weeks followed by ALECSAT every 3 months	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

Outcome Measures

Primary Outcome Measures :

1. Progression Free Survival [ Time Frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause ]
   Compare the progression free survival between patients who receive ALECSAT as add on to SoC and patients who only receive SoC

Secondary Outcome Measures :

1. Proportion of patients alive at 12 and 24 months [ Time Frame: 24 months after LPFV or when 47 patients has reached investigator assessed disease progression or death from any cause ]
   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
2. Frequency and Severity of treatment related Adverse Events [ Time Frame: Up to 24 months after randomisation of last patient ]
   Comparison of frequency and severity of treatment related AEs in the 2 study groups

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Sweden

Sahlgrenska University Hospital

Göteborg, Sweden

Ryhov hospital

Jönköping, Sweden, 55185

Skånes university hospital

Lund, Sweden, 221 85

Karolinska University hospital

Stockholm, Sweden, 171 76

Sponsors and Collaborators

CytoVac A/S

Investigators

• Principal Investigator: Katja Werlenius, PhD; Sahlgrenska University Hospital, Gothenburg

More Information

• Responsible Party: CytoVac A/S
• ClinicalTrials.gov Identifier: NCT02799238
• Other Study ID Numbers: CV-006
• First Posted: June 14, 2016
• Last Update Posted: April 30, 2020
• Last Verified: April 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

Keywords provided by CytoVac A/S:

glioblastoma, GBM, immunotherapy, autologous lymphoid effector cells specific against tumour cells, ALECSAT, Stupp regimen, TMZ, radiotherapy

Additional relevant MeSH terms:

Glioblastoma; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Temozolomide; Antineoplastic Agents, Alkylating; Alkylating Agents; Molecular Mechanisms of Pharmacological Action; Antineoplastic Agents