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Clinical Trials/EUCTR2021-000700-38-IT
EUCTR2021-000700-38-IT
Active, not recruiting
Phase 1

A follow-up study evaluating the long term safety of autologous CD34+-enriched hematopoietic progenitor cells genetically modified with a lentiviral vector encoding for the human interferon-a2 gene previously administered to patients with glioblastoma multiforme - TEM-LT

GENENTA SCIENCE SR0 sites5 target enrollmentJune 7, 2021
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ConditionsGlioblastoma multiforme (GBM)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]

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Glioblastoma multiforme (GBM)
Sponsor
GENENTA SCIENCE SR
Enrollment
5
Status
Active, not recruiting
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
June 7, 2021
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
GENENTA SCIENCE SR

Eligibility Criteria

Inclusion Criteria

  • •Inclusion Criteria at Entry:
  • •Patients who have received Temferon and completed 2 years follow\-up in the TEM\-GBM study.
  • •Able and willing to provide written informed consent and comply with the study protocol and procedures.
  • •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 4
  • •F.1\.3 Elderly (\>\=65 years) yes
  • •F.1\.3\.1 Number of subjects for this age range 1

Exclusion Criteria

  • •There are no exclusion criteria for this study.

Outcomes

Primary Outcomes

Not specified

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