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Autologous Genetically modified T cells · 1 trial · 1 indication
Number of Participants with Adverse Events related to study treatment
| Arm | Type | Description |
|---|---|---|
| Autologous Genetically modified T cells | EXPERIMENTAL | Patients with advanced myeloma and who are candidates for autologous stem cell transplants, or syngeneic stem cell transplants (SSCT), will be eligible. Prior to full screening on this study, patients will undergo prescreening to evaluate HLA-A type and presence of NY-ESO-1c259T/LAGE antigen. Patients will undergo a steady-state mononuclear cell apheresis for T cell collection, with an optional second collection. Once mononuclear cells have been collected, patients (or donors in the case of SSCT) will then undergo hematopoietic stem cell mobilization. Patients will receive a dose \>0.1-1 x 10¹º anti-CD3/anti-CD28-costimulated autologous T cells which have been genetically modified to express high affinity NY-ESO-1c259 TCRs. |
| Name | Type | Description |
|---|---|---|
| Autologous Genetically modified T cells | GENETIC | Patients will undergo myeloma restaging at days +42, +100, 6 months, 9 months and 1 year post infusion. At this point, in accordance with FDA Guidelines, all patients will enter long term follow up (LTFU) and be followed biannually for monitoring for gene transfer delayed adverse events until year 5 post infusion. From year 5, all patients will require annual LTFU visits for monitoring for delayed adverse events until year 15 after receiving the genetically modified T cells. Patients whose disease progresses prior to year 1 will enter LTFU at time of progression; however these patients will be seen quarterly from progression until year 1 post infusion and then follow the LTFU schedule mentioned above. |
Inclusion Criteria: * Myeloma has relapsed, progressed, or failed to respond after at least one prior course of therapy (consisting of at least 2 treatment cycles or months of therapy) * Myeloma has responded partially to initial therapy but a complete response (immunofixation negative and normal s...
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Autologous genetically modified T cells are a gene therapy approach in which a patient's own T cells are genetically altered outside the body and then returned to the patient. GSK plc is developing this therapy for multiple myeloma, a cancer of plasma cells in the bone marrow.
Autologous genetically modified T cells are being studied for the treatment of multiple myeloma. The therapy is designed for patients with this blood cancer, and the clinical program has focused on advanced multiple myeloma in adults.
This therapy targets ADA, which is an exogenous gene introduced into the patient's T cells. The target class is an exogenous gene, meaning the modified cells are designed to express ADA as part of the treatment approach for multiple myeloma.
GSK plc, which trades under the ticker GSK, is the developer of autologous genetically modified T cells. The company is responsible for the clinical development of this gene therapy candidate in multiple myeloma.
Autologous genetically modified T cells are in Phase 2 clinical development. The program has completed one Phase 2 trial and is not currently listed as having active trials. It is an investigational therapy and has not been approved by the FDA.
The clinical program includes one completed Phase 2 trial, NCT01352286, titled Redirected Auto T Cells for Advanced Myeloma. It enrolled 25 participants in the United States. The study was uncontrolled, non-randomized, and not double-blind, and it included adults aged 18 years and older.