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Posoleucel

Phase 3

Adenovirus Infection | Cell therapy | Infectious Disease |Kalaris Therapeutics, Inc.|Trials Updated: May 9, 2024

Posoleucel development status

Highest phase Phase 3 (NCT05179057)
Phase scored for KLRSPhase 2
Registered trials 1 across 1 sponsor since Jan 2001

Posoleucel target and mechanism

Target class-Cel (Cell Tx)
ModalityCell therapy

Also known as Posoleucel (ALVR105)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Posoleucel clinical trials

Posoleucel · 1 trial · 6 indications

Phase 2 1
NCT04693637Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell TransplantAdenovirus Infection
COMPLETED26 Analytics
PHASE2COMPLETED
Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant
Adenovirus InfectionUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Through Week 14

The number of participants experiencing clinically significant infections or episodes of end-organ disease due to AdV, BKV, CMV, EBV, HHV-6, or JCV through Week 14

Secondary Endpoints

Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease
Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to Adenovirus (AdV)
Through Week 26
Number of Participants Experiencing Clinically Significant Infections or Episodes of End-organ Disease Due to BKV
Through Week 26
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposePREVENTION

Treatment Arms

ArmTypeDescription
Posoleucel (ALVR105)EXPERIMENTALAdministered as 2-4 milliliter infusion

Interventions

NameTypeDescription
Posoleucel (ALVR105)BIOLOGICALAdministered as 2-4 milliliter infusion
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Eligibility Criteria

Age Range1 Year to N/A
SexALL
Healthy VolunteersNo
Study Sites16

Key Inclusion Criteria * ≥1 year of age at the day of screening visit. * Either no evidence of viral infection or viremia, or asymptomatic, viral infection with 3 or fewer viruses of interest at time of screening * Within 15 and 42 days of receiving a first allogeneic HCT and have demonstrated clin...

Countries:United States
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Frequently asked questions about Posoleucel

What is Posoleucel used for?

Posoleucel is an investigational cell therapy being studied for the prevention of adenovirus infection in patients who have received an allogeneic hematopoietic cell transplant. It has also been evaluated for prevention of several other viral infections in that same transplant setting, including BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus.

Who is developing Posoleucel?

Posoleucel is being developed by Kalaris Therapeutics, Inc., which trades under the ticker KLRS. The company is the sponsor of the clinical program evaluating the therapy in transplant recipients.

What phase is Posoleucel in?

Posoleucel is in Phase 2 development. It is an investigational cell therapy and is not approved for commercial use. The Phase 2 study evaluating it has been completed.

What clinical trials is Posoleucel in?

Posoleucel has been studied in the Phase 2 trial NCT04693637, titled Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant. The trial enrolled 26 patients in the United States and has been completed. It was an uncontrolled study without randomization or blinding.

Is Posoleucel the same as ALVR105?

Yes. Posoleucel is also known as ALVR105, and it was formerly called Viralym-M. These names refer to the same investigational cell therapy developed by Kalaris Therapeutics.