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NCT06900192

A Multicenter Phase 1 Study of Orca-Q in Primary Progressive Multiple Sclerosis

StatusNot Yet Recruiting
PhasePhase 1
Primary completion (estimated)
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Record History

All 2 versions: 2 with changes below. See every version on ClinicalTrials.gov ↗

  1. Sponsor changed: Stanford University to Orca Biosystems, Inc. Show 10 more changesShow less
    • Primary completion moved earlier from Aug 2029 to Jun 2028
    • Start date: Mar 2025 to Mar 2027
    • Eligibility criteria expanded, about 187 words
    • Study completion pushed from Aug 2029 to Dec 2032
    • Interventions modified
    • Secondary endpoints: 2 to 14
    • Primary endpoint revised
    • Study title revised
    • Study description shortened, about 2 words
    • Collaborators shortened, about 3 words
  2. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Severe acute graft-versus-host-disease-free survival
Timeframe: Up to 6 months after infusion

Secondary (14)

Event-Free Survival (EFS)
Loss of Neurological Function or Relapse
Overall Survival (OS)
Treatment-Related Mortality (TRM)
Incidence of Disease-Modifying Therapy Use for PPMS After Orca-Q
Show 9 moreShow less
Incidence of aGVHD
Severity of aGVHD
Incidence chronic graft-versus-host disease (cGVHD)
Severity of cGVHD
Incidence of Primary Graft Failure
Incidence of Secondary Graft Failure
Time to Neutrophil Engraftment
Development of Infectious Complications
Regimen-Related Toxicity

Arms and interventions

Orca-Q Graft with myeloablative conditioning regimenExperimental

Donor Orca-Q stem cell graft

Biologicals: Orca-Q

Drugs: myeloablative regimen, Tacrolimus