Trial of Orca-T Following Reduced Intensity or Nonmyeloablative Conditioning in Patients With Acute Myeloid Leukemia or Myelodysplastic Syndrome

Part of paid clinical trials in Los Angeles, California.

Sponsor
Orca Biosystems, Inc.
Study ID
NCT07216443
Phase
PHASE2
Status
Recruiting
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Conditions

  • Leukemia, Myeloid, Acute
  • Mixed Phenotype Acute Leukemia
  • Myelodysplastic Syndromes

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Orca-T — BIOLOGICAL
    An allogeneic stem cell and T-cell immunotherapy biologic

Study Details

This study will evaluate the safety, tolerability, and efficacy of Orca-T in participants undergoing reduced intensity or non-myeloablative allogeneic hematopoietic cell transplantation (alloHCT) for hematologic malignancies. Orca-T is an allogeneic stem cell and T-cell immunotherapy biologic manufactured for each patient (transplant recipient) from the mobilized peripheral blood of a specific, unique donor. It is composed of purified hematopoietic stem and progenitor cells (HSPCs), purified regulatory T cells (Tregs), and conventional T cells (Tcons).

Key Dates

Start date
Dec 9, 2025
Status verified
Apr 2026
Primary completion
Nov 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
80 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Orca-T
    Participants will receive \[RIC or NMA conditioning\] + Orca-T + single-agent tacrolimus based on eligibility and investigator's choice of conditioning regimen.

Primary Outcome Measure

RIC Cohort: GVHD-free and relapse-free survival (GRFS) [ Time Frame: Day 0 through day +365 after transplantation ]

Central Contacts

Locations (5)

FacilityCityStateZIPSite coordinators
UCLA Department of MedicineLos AngelesCalifornia90095
Caspian Oliai
[email protected]
310-794-0824
Moffitt Cancer CenterTampaFlorida33612
Nelli Bejanyan, MD
[email protected]
(813) 745-6008
John Theurer Cancer Center at Hackensack University Medical CenterHackensackNew Jersey07601
Siddhartha Reddy
[email protected]
551-996-5900
Oregon Health and Science UniversityPortlandOregon97239
Arpita Gandhi
[email protected]
503-494-5058
Vanderbilt University, Ingram Cancer CenterNashvilleTennessee37232
Bhagirathbhai Dholaria
[email protected]
615-875-3112

Find similar trials in Los Angeles, CA

By research site
UCLA Department of Medicine· Los Angeles, CAMoffitt Cancer Center· Tampa, FLJohn Theurer Cancer Center at Hackensack University Medical Center· Hackensack, NJOregon Health and Science University· Portland, ORVanderbilt University, Ingram Cancer Center· Nashville, TN

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