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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 is an investigational therapy being studied for BK Virus Nephropathy, a viral infection that can affect kidney transplant patients. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Posoleucel cells is a monoclonal antibody, though its specific molecular target has not been disclosed. It is being evaluated for its potential to address BK Virus Nephropathy in patients who have undergone kidney transplantation.
Posoleucel cells is being developed by Kalaris Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KLRS.
Posoleucel cells is in Phase 2 clinical development. It is an investigational drug and has not received approval from the U.S. Food and Drug Administration or any other regulatory agency.
Posoleucel cells has one completed Phase 2 clinical trial, identified as NCT04605484, which studied the drug 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 cells was formerly known as ALVR105 and Viralym-M. The clinical trial NCT04605484 explicitly notes that Posoleucel was previously referred to by these alternative names.