Long-term Follow-up of Participants Treated With Galapagos Chimeric Antigen Receptor (CAR) T-cell Therapies
Recruiting
Phase 3
Interventional Study
Hematological Malignancies
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Other
- Participants needed
- 546 (estimated)
- Sponsor
- Lakefront Biotherapeutics NV · Industry
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About This Trial
This is a long-term follow-up study for participants treated with Galapagos (GLPG) CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion.
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors (e.g. lentiviral vectors), long term safety and efficacy follow up of treated patients is …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
* All participants who have been treated with a Galapagos CAR T-cell therapy in a clinical trial or Managed Access Program.
Exclusion Criteria:
* There are no exclusion criteria for this study
Contacts