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PLX-R18

Phase 1

Incomplete HCT (Hematopoietic Cell Transplantation) | Monoclonal antibody | Other |Pluri Inc.|Trials Updated: Dec 16, 2022

PLX-R18 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Dec 2001

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDDMC
Total Trials1
Total Enrollment21

FDA Designations

No designations recorded

PLX-R18 clinical trials

PLX-R18 · 1 trial · 1 indication

Phase 1 1
NCT03002519Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell TransplantationIncomplete HCT (Hematopoietic Cell Transplantation)
COMPLETED21 Analytics
PHASE1COMPLETED
Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation
Incomplete HCT (Hematopoietic Cell Transplantation)Unlock trial analytics

Study Endpoints

Primary Endpoints

Emergent Adverse Events (AEs)
Recorded after time of consent throughout the study until the last visit (~1 year)
Safety laboratory values (including immunological testing)
Blood samples will be collected on each visit, through study completion (~1 year)
Vital signs
Will be assessed during each visit, through study completion (~1 year)
ECG
Will be assessed during the screening visit, before each IP treatment visit and on the 14th day of participation (visit 5).
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
PLX-R18EXPERIMENTALDose Escalation- first three subjects will be enrolled in the low dose cohort, 6 subjects in the intermediate-dose cohort, and 15 subjects in the high dose cohort.

Interventions

NameTypeDescription
PLX-R18BIOLOGICALIntramuscular (IM) administration of PLX-R18
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites10

Inclusion Criteria: 1. Age ≥18 years. 2. At least 3 months after HCT, either autologous or allogeneic (of any source, with any preparatory regimen, for any indication), prior to study treatment. 3. Sustained platelet count ≤50,000/µL, and/or sustained Hb ≤8 g/dL and/or sustained ANC ≤1000/mm3, attr...

Countries:United StatesIsrael
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Frequently asked questions about PLX-R18

What is PLX-R18?

PLX-R18 is an investigational monoclonal antibody developed by Pluri Inc. It is being studied for incomplete hematopoietic recovery following hematopoietic cell transplantation, a condition in which blood cell production does not fully recover after a transplant. It has completed a Phase 1 clinical trial and is not approved for commercial use.

What is PLX-R18 used for?

PLX-R18 is being developed for incomplete hematopoietic recovery following hematopoietic cell transplantation (HCT). The condition involves inadequate restoration of blood cell production after transplant. The only clinical study of PLX-R18 to date enrolled 21 adult subjects with this condition in the United States and Israel.

Who makes PLX-R18?

PLX-R18 is developed by Pluri Inc., which trades under the ticker PLUR. Pluri is the sponsor of the clinical program evaluating the drug in incomplete hematopoietic recovery after hematopoietic cell transplantation.

What phase is PLX-R18 in?

PLX-R18 is in Phase 1 clinical development. It is investigational and has not been approved by the FDA or any other regulatory agency. One Phase 1 trial has been completed, and no active trials of PLX-R18 are currently listed.

What clinical trials is PLX-R18 in?

PLX-R18 has been studied in one completed Phase 1 trial, NCT03002519, titled Safety Evaluation of Intramuscular Injections of PLX-R18 in Subjects With Incomplete Hematopoietic Recovery Following Hematopoietic Cell Transplantation. The trial enrolled 21 adults across sites in the United States and Israel and was an uncontrolled, non-randomized study.