Defined by parent protocol. The study will enroll all adult and paediatric subjects who received at least one genetically modified T cells infusion in a previous Celgene sponsored study.
Conditions
Brief summary
Safety endpoints:Incidence of delayed adverse events considered at least possibly related to GM T cell therapy (i.e. neurologic/autoimmune/hematologic disorders, infections, reportable new malignancies, hospitalizations, etc.)., Safety endpoints:Incidence of certain hematologic new malignancies irrespective of causality., Safety endpoints:Persistence of GM T cells, analysis of vector integration sites, incidence of RCL., Safety endpoints:Pediatrics only: Physical growth as assessed by physical examination and sexual maturity., Efficacy endpoints:Overall survival (subjects with original diagnosis of malignancies), Efficacy endpoints:Proportion of subjects who progressed on the study (subjects with original diagnosis of malignancies), Efficacy endpoints:Proportion of subjects experiencing a disease relapse (subjects with autoimmune diseases), The timeframe for safety and efficacy assessments is up to 15 years from last GM T-cell infusion. For pediatric participants will continue until they reach Tanner Stage 5. Assessments will start 3 months after the last GM T-cell infusion, then will continue at a frequency of once every 6 months until Month 60, and then once a year until the EOS.
Detailed description
Lymphocyte count (B-cell) for participants that received a CD-19-directed GM T-cell therapy. This assessment will be required up to 5 years from the last GM T-cell infusion (with the same frequency described for the primary endpoints) and after that might be concluded if B-cell levels are considered back to normal levels; otherwise follow up continues for up to 15 years if B-cell levels remain below normal levels.
Interventions
DRUGDual Targeting BCMAxGPRC5D CAR T
Sponsors
Celgene Corp.
Eligibility
Sex/Gender
All
Age
0 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety endpoints:Incidence of delayed adverse events considered at least possibly related to GM T cell therapy (i.e. neurologic/autoimmune/hematologic disorders, infections, reportable new malignancies, hospitalizations, etc.)., Safety endpoints:Incidence of certain hematologic new malignancies irrespective of causality., Safety endpoints:Persistence of GM T cells, analysis of vector integration sites, incidence of RCL., Safety endpoints:Pediatrics only: Physical growth as assessed by physical examination and sexual maturity., Efficacy endpoints:Overall survival (subjects with original diagnosis of malignancies), Efficacy endpoints:Proportion of subjects who progressed on the study (subjects with original diagnosis of malignancies), Efficacy endpoints:Proportion of subjects experiencing a disease relapse (subjects with autoimmune diseases), The timeframe for safety and efficacy assessments is up to 15 years from last GM T-cell infusion. For pediatric participants will continue until th | — |
Secondary
| Measure | Time frame |
|---|---|
| Lymphocyte count (B-cell) for participants that received a CD-19-directed GM T-cell therapy. This assessment will be required up to 5 years from the last GM T-cell infusion (with the same frequency described for the primary endpoints) and after that might be concluded if B-cell levels are considered back to normal levels; otherwise follow up continues for up to 15 years if B-cell levels remain below normal levels. | — |
Countries
Austria, Belgium, Czechia, Denmark, Finland, France, Germany, Greece, Italy, Netherlands, Norway, Poland, Portugal, Romania, Spain, Sweden
Outcome results
None listed