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Also known as Posoleucel (formerly known as ALVR105) cells
Posoleucel cells · 1 trial · 2 indications
An adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. TEAEs are defined as AEs with a start date and time on or after the first dose of study treatment through the end of study. Clinically significant changes in vital signs, physical exams, laboratory assessments and electrocardiograms were also reported as TEAEs.
| Arm | Type | Description |
|---|---|---|
| Posoleucel | EXPERIMENTAL | Arm 1: Regimen A |
| Posoleucel and Placebo | EXPERIMENTAL | Arm 2: Regimen B |
| Placebo | PLACEBO_COMPARATOR | Arm 3: Regimen A |
| Name | Type | Description |
|---|---|---|
| Posoleucel (formerly known as ALVR105) cells | BIOLOGICAL | Infusion |
| Placebo (visually identical to Posoleucel) | BIOLOGICAL | Infusion |
Inclusion Criteria: * Patients who had a kidney transplant performed greater than or equal to 28 days prior to enrollment * At least 1 identified, suitably matched Posoleucel (ALVR105) cell line for infusion is available. * Capable of giving signed informed consent which includes compliance with th...
Posoleucel cells are being developed for BK virus nephropathy, a viral infection that affects kidney transplant recipients. The therapy is an investigational cell therapy in Phase 2 development for this indication. It is not yet approved for commercial use.
Posoleucel cells are being developed by Kalaris Therapeutics, Inc., which trades under the ticker KLRS. The company is advancing this cell therapy as a potential treatment for BK virus nephropathy in kidney transplant patients.
Posoleucel cells are in Phase 2 clinical development. The development program includes one completed Phase 2 trial. The therapy remains investigational and has not been approved by the FDA for any indication.
One Phase 2 clinical trial has been completed for Posoleucel cells: NCT04605484, titled "Study of Posoleucel (Formerly Known as ALVR105; Viralym-M) in Kidney Transplant Patients With BK Viremia." The trial enrolled 61 participants in the United States and was randomized, double-blind, and placebo-controlled.
Yes, Posoleucel was formerly known as ALVR105. The therapy has also been referred to as Viralym-M. These names refer to the same investigational cell therapy being developed by Kalaris Therapeutics for BK virus nephropathy.