Phase 2 / Phase 3: Gene-modified (GM) T cell therapy for Neoplasms
This is a prospective study for the long-term follow-up (LTFU) of safety and how well it works for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Participants who received at least one infusion of GM T cells will be asked to enroll in this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.
Official registry: https://clinicaltrials.gov/study/NCT03435796 · Celgene · enrollment listed as 1,541
What this phase means
Phase 2/3: earlier tests looked promising enough to expand. This stage asks, in a larger group, whether the treatment really works and is safe enough to seek approval.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are Gene-modified (GM) T cell therapy. The registry lists allocation as na. This is a prospective study for the long-term follow-up (LTFU) of safety and how well it works for all pediatric and adult participants exposed to Gene-modified (GM) T-cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study.
They plan to enroll about 1,541 people at 225 sites. Taking part typically means genetic testing or a gene-targeted therapy plus check-ins.
Official title (unrewritten)
Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells
Interventions: Gene-modified (GM) T cell therapy
Primary outcome (registry wording): Incidence of delayed Adverse Events (AEs)
Who it is for (from inclusion criteria)
- The registry does not list clear inclusion rules. Call the study team before assuming you qualify.
Who the registry excludes
- Other protocol-defined inclusion/
Public study contact (from the registry)
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
225 listed- University of Alabama Birmingham — Birmingham, Alabama (recruiting)
- Banner MD Anderson Cancer Center — Gilbert, Arizona (recruiting)
- Mayo Clinic Phoenix — Phoenix, Arizona (recruiting)
- Local Institution - 01039 — Scottsdale, Arizona (completed)
- Local Institution - 01021 — Tucson, Arizona (withdrawn)
- City Of Hope — Duarte, California (recruiting)
- University Of California San Diego Moores Cancer Center — La Jolla, California (recruiting)
- Local Institution - 01206 — Los Angeles, California (withdrawn)
- Local Institution - 01043 — Sacramento, California (withdrawn)
- University of California, San Francisco- California — San Francisco, California (recruiting)
- UCLA Medical Centre-Santa Monica — Santa Monica, California (recruiting)
- Stanford Cancer Center — Stanford, California (recruiting)
+ 121 sites outside the US on the same record
FAQ about this NCT record
Is NCT03435796 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT03435796?
Phase 2 / Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT03435796?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary