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Personalized Neoantigen DNA vaccine · 1 trial · 1 indication
* Safety will be defined as a \< 33% treatment-related DLT rate related to vaccination alone or in combination with retifanlimab, by the end of the DLT observation period for a given cohort. * A DLT will be defined as any grade 3 toxicity or greater according to CTCAE v5 considered at least possibly related to study treatment (exceptions are listed in the protocol). * The DLT observation period begins with date of first vaccine administration and continues for 30 days from administration of first dose of retifanlimab. For patients in Cohort A, this is Day 87 (first dose of retifanlimab is given with vaccine Dose 3 on Day 57), and for patients in Cohort B, this is Day 30 (first dose of retifanlimab is given with vaccine Dose 1 on Day 1).
| Arm | Type | Description |
|---|---|---|
| Cohort A: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort A will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection alone during the first two priming doses, then concurrently with retifanlimab during the subsequent boosting doses (Doses 3 through 6) * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| Cohort B: Personalized neoantigen DNA vaccine + retifanlimab | EXPERIMENTAL | * Cohort B will receive the personalized neoantigen DNA vaccine via electroporation mediated IM injection plus concurrent retifanlimab beginning with Dose 1 and continuing for a total of 6 doses. * The personalized neoantigen DNA vaccine will be given once every 28 days for up to 6 doses. Retifanlimab is given at a fixed dose of 500 mg every 28 days. * Patients may receive up to 6 doses of personalized neoantigen DNA vaccine and up to 12 months total of retifanlimab |
| Name | Type | Description |
|---|---|---|
| Personalized Neoantigen DNA vaccine | BIOLOGICAL | The sites of immunization may be rotated for each of the immunizations. |
| Retifanlimab | BIOLOGICAL | Retifanlimab will be supplied by Incyte. |
| TDS-IM v 2.0 electroporation device | DEVICE | Each DNA vaccination will be 1 mL vaccine administered intramuscularly using an integrated electroporation administration system |
Step 1 Inclusion Criteria for Tissue Sequencing: * Newly diagnosed histologically or molecularly consistent with WHO grade IV high grade glioma, IDH wildtype. * Patients who had prior craniotomy with biopsy, subtotal resection, total gross resection, or re-resection will be permitted. * Consent to ...
The Personalized Neoantigen DNA vaccine is being studied for the treatment of unmethylated glioblastoma, a type of brain cancer. It is currently in Phase 1 clinical development and is intended for patients with newly diagnosed, unmethylated glioblastoma.
The Personalized Neoantigen DNA vaccine is being developed by Incyte Corporation, a biopharmaceutical company traded on the NASDAQ under the ticker symbol INCY. The company is conducting a Phase 1 clinical trial to evaluate the vaccine in patients with unmethylated glioblastoma.
The Personalized Neoantigen DNA vaccine is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 1 trial is actively enrolling or has enrolled participants, but it is not yet recruiting new participants.
The Personalized Neoantigen DNA vaccine is being evaluated in a single Phase 1 clinical trial with the identifier NCT05743595. This trial is studying the vaccine in combination with retifanlimab, a PD-1 blockade therapy, in patients with newly diagnosed, unmethylated glioblastoma. The trial is active but not recruiting and has an enrollment of 27 participants.
The Personalized Neoantigen DNA vaccine is designed to target neoantigens, which are unique mutations found on tumor cells. By delivering DNA that encodes these neoantigens, the vaccine aims to stimulate the patient's immune system to recognize and attack cancer cells. It is being tested in combination with retifanlimab, a PD-1 inhibitor, to enhance the immune response.