Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Autologous FL vaccine · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Arm 1 | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Autologous FL vaccine | BIOLOGICAL | 1.0 mg of vaccine subcutaneously (s.c.) on Day 1, and followed by 125 µg GM-CSF s.c. at Day 1 -4, monthly until 8th vaccination, bimonthly until 12th vaccination (month 16) |
Inclusion Criteria: * Subjects with histologically proven follicular lymphoma (grade 1, 2, or 3a), in clinical relapse/progression requiring treatment * Subjects must have had first line treatment consisting of rituximab with or without rituximab maintenance therapy (i.e. rituximab monotherapy, R-C...
The autologous FL vaccine is an investigational cell-based immunotherapy developed by Icon Plc for follicular lymphoma, a type of non-Hodgkin lymphoma. It is made from a patient's own cells, which is what autologous means. It has been studied in a single Phase 1 clinical trial and is not an approved treatment.
The autologous FL vaccine is being studied as a treatment for follicular lymphoma, a slow-growing B-cell lymphoma. It is intended to stimulate the patient's immune system against their own tumor cells. The only clinical trial of this vaccine enrolled 28 adults with follicular lymphoma in the United States.
The autologous FL vaccine is developed by Icon Plc, which trades on the Nasdaq under the ticker ICLR. Icon Plc is a clinical research organization and healthcare intelligence company. The vaccine is an investigational product and has not been approved by any regulatory agency.
The autologous FL vaccine is in Phase 1 development. It has completed one Phase 1 clinical trial, and no active trials are currently listed. As an investigational therapy, it has not received FDA approval and remains in early-stage clinical research.
The autologous FL vaccine has been evaluated in one completed Phase 1 trial, NCT01022255, titled Autologous Vaccine for Follicular Lymphoma. The trial enrolled 28 participants aged 18 years and older in the United States. It was an uncontrolled, non-randomized study, and no other trials are listed.