EUCTR2021-000700-38-ITActive, not recruitingPhase 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 enrollmentStarted: June 7, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Enrollment
- 5
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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.
Investigators
Similar Trials
Active, not recruiting
Phase 1
ong-Term Evaluation of BIIB067EUCTR2016-003225-41-PLBiogen Idec Research Limited183
Completed
Not Applicable
An Extension Study to Assess the Long-Term Safety, Tolerability, Pharmacokinetics, and Effect on Disease Progression of BIIB078 Administered to Previously Treated Adults with C9ORF72-Associated Amyotrophic Lateral SclerosisAmyotrophic lateral sclerosisneurodegenerative disease10029317NL-OMON49747Biogen1
Active, not recruiting
Phase 1
ong-Term Evaluation of BIIB067Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-003225-41-BEBiogen Idec Research Limited183
Active, not recruiting
Phase 1
ong-Term Evaluation of BIIB067Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-003225-41-DEBiogen Idec Research Limited183
Active, not recruiting
Phase 1
ong-Term Evaluation of BIIB067Amyotrophic Lateral Sclerosis (ALS)MedDRA version: 20.0Level: PTClassification code 10077024Term: Familial amyotrophic lateral sclerosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersMedDRA version: 21.1Level: PTClassification code 10002026Term: Amyotrophic lateral sclerosisSystem Organ Class: 10029205 - Nervous system disordersEUCTR2016-003225-41-ESBiogen Idec Research Limited183