A Phase 1 Study of Orca-Q in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies

Part of paid clinical trials in Duarte, California.

Sponsor
Orca Biosystems, Inc.
Study ID
NCT03802695
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 78 Years
Healthy Volunteers
Not accepted

Interventions

  • OrcaGraft (Orca-Q) — BIOLOGICAL
    engineered donor allograft

Study Details

This study will evaluate the safety, tolerability, and efficacy of engineered donor grafts ("OrcaGraft"/"Orca-Q") in participants undergoing allogeneic hematopoietic cell transplant (alloHCT) transplantation for hematologic malignancies.

Key Dates

Start date
Apr 8, 2019
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
300 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A
    Recipients with human leukocyte antigen (HLA)-identical related or unrelated or 1-allele mismatched (7/8 alleles) unrelated donor undergoing myeloablative conditioning (MAC); with single- or dual-agent graft-versus-host disease (GVHD) prophylaxis given
  • Experimental: Arm B
    Recipients with haploidentical-related donors undergoing MAC; with single- or dual-agent GVHD prophylaxis given
  • Experimental: Arm C
    Recipients with an HLA-identical related or unrelated donor undergoing MAC; no GVHD prophylaxis given
  • Experimental: Arm D
    Recipients with an HLA-identical related or unrelated donor undergoing non-myeloablative (NMA)/reduced intensity conditioning (RIC); with dual agent GVHD prophylaxis given
  • Experimental: Arm E
    Recipients with 1-allele mismatched (7/8 alleles) unrelated donor undergoing NMA/RIC; with dual-agent GVHD prophylaxis given
  • Experimental: Arm F
    Recipients with haploidentical-related donors undergoing NMA/RIC; with dual-agent GVHD prophylaxis given

Primary Outcome Measure

Dose Limiting Toxicities through Day +28 (dose escalation) [ Time Frame: 28 Days after administration of Orca-Q/OrcaGraft ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
City of HopeDuarteCalifornia91010
Amandeep Salhotra, MD
UC DavisSacramentoCalifornia95817
Mehrdad Abedi, MD
Stanford Health CareStanfordCalifornia94305
Robert Lowsky, MD
Moffitt Cancer CenterTampaFlorida33612
Rawan Faramand, MD
Emory UniversityAtlantaGeorgia30322-
The University of Kansas HospitalKansas CityKansas66160-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065
Roni Tamari, MD
Ohio State UniversityColumbusOhio43210-
University of Texas MD Anderson Cancer CenterHoustonTexas77054
Samer Srour, MD
Fred Hutchinson Cancer CenterSeattleWashington98109
Boglarka Gyurkocza, MD
Froedtert Memorial Lutheran HospitalMilwaukeeWisconsin53226-

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City of Hope· Duarte, CAUC Davis· Sacramento, CAStanford Health Care· Stanford, CAMoffitt Cancer Center· Tampa, FLEmory University· Atlanta, GAThe University of Kansas Hospital· Kansas City, KS

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