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Posoleucel

Phase 2

Adenovirus Infection | Monoclonal antibody | Infectious Disease |Kalaris Therapeutics, Inc.|Last Updated: May 9, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment26

FDA Designations

No designations recorded

Clinical trial landscape

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 monoclonal antibody being developed for the prevention of adenovirus infection. It is also being studied for the prevention of BK virus, cytomegalovirus, Epstein-Barr virus, human herpes virus-6, and JC virus infections in patients who have undergone allogeneic hematopoietic cell transplant.

Who makes Posoleucel?

Posoleucel is being developed by Kalaris Therapeutics, Inc., a biopharmaceutical company traded on the stock exchange under the ticker symbol KLRS.

What phase is Posoleucel in?

Posoleucel is in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is not currently in any active clinical trials.

What clinical trials is Posoleucel in?

Posoleucel has been studied in one completed Phase 2 clinical trial, identified as NCT04693637. This trial evaluated Posoleucel for multi-virus prevention in patients post-allogeneic hematopoietic cell transplant, enrolling 26 participants in the United States.

Is Posoleucel the same as ALVR105 or Viralym-M?

Yes, Posoleucel is also known as ALVR105 and was formerly called Viralym-M. The completed clinical trial NCT04693637 was titled "Posoleucel (ALVR105, Formerly Viralym-M) for Multi-Virus Prevention in Patients Post-Allogeneic Hematopoietic Cell Transplant."