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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 is an investigational gene therapy being studied for the treatment of multiple myeloma, a type of blood cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Autologous Genetically modified T cells is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. The therapy is in Phase 2 clinical development for multiple myeloma.
Autologous Genetically modified T cells is in Phase 2 clinical development. It is an investigational therapy and has not yet received regulatory approval. One Phase 2 clinical trial for this therapy has been completed.
Autologous Genetically modified T cells has been studied in one completed clinical trial with the identifier NCT01352286, titled 'Redirected Auto T Cells for Advanced Myeloma'. This Phase 2 trial enrolled 25 participants with multiple myeloma in the United States.
Autologous Genetically modified T cells is not FDA approved. It is an investigational gene therapy currently in Phase 2 clinical development for multiple myeloma. The therapy remains under study and has not been authorized for commercial use.