Precision-T: A Randomized Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (Orca-T)

April 8, 2024 updated by: Orca Biosystems, Inc.

A Randomized Phase III Trial of Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation With Either Orca-T, a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells, or Standard-of-Care Allogeneic Graft

This study will evaluate the safety, tolerability, and efficacy of Orca-T, 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) in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation for hematologic malignancies.

This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Cross reference NCT04013685

Study Type

Interventional

Enrollment (Estimated)

174

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: James S McClellan, MD PhD
  • Phone Number: 530 414 9743
  • Email: info@orcabio.com

Study Contact Backup

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Amandeep Salhotra
      • Los Angeles, California, United States, 90095
      • Sacramento, California, United States, 95817
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Contact:
          • Everett Meyer, MD, PhD
        • Contact:
    • Colorado
      • Denver, Colorado, United States, 80218
        • Recruiting
        • Colorado Blood Cancer Institute
        • Contact:
          • Alireza Eghtedar, MD
          • Phone Number: 720-754-4800
    • Florida
      • Miami, Florida, United States, 33136
        • Recruiting
        • University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center
        • Contact:
          • Antonio M Jimenez, MD
      • Tampa, Florida, United States, 33612
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute - Emory University
        • Contact:
          • Edmund Waller, MD, PhD
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Satyajit Kosuri, MD
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Contact:
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Recruiting
        • University of Michigan Health System - Michigan Medicine
        • Contact:
          • Cancer Center Hotline
          • Phone Number: 800-865-1125
        • Principal Investigator:
          • John Magenau, MD
    • New York
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center
        • Contact:
          • Roni Tamari, MD
        • Contact:
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine - New York-Presbyterian Hospital
        • Contact:
          • Alexandra Gomez Arteaga, MD
        • Contact:
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic
        • Contact:
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Recruiting
        • OU Health Stephenson Cancer Center
        • Contact:
          • Jennifer Holter-Chakrabarty, MD
          • Phone Number: 405-271-8299
        • Contact:
          • Silas Day
          • Phone Number: 48748 (405) 271-8001
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health & Sciences University - Knight Cancer Institute
        • Contact:
          • Arpita Gandhi, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
          • Bhagirathbhai Dholaria, MD
          • Phone Number: 615-343-6653
        • Contact:
      • Nashville, Tennessee, United States, 37239
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Jeremy Pantin, MD
          • Phone Number: 615-342-3385
    • Utah
      • Salt Lake City, Utah, United States, 84112

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1

  • Diagnosed with one of the following diseases:

    • Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi), with or without the presence of known minimal residual disease
    • Myelodysplastic syndromes (MDS) that are indicated for alloHSCT per 2017 International Expert Panel recommendations and/or have therapy-related/secondary MDS, with ≤ 10% blast burden in the bone marrow

  • Planned to undergo MA-alloHCT including one of the following myeloablative conditioning regimens:

    • TBI/Cy
    • TBI/Etoposide
    • BFT
  • Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  • Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  • Negative serum or urine beta-HCG test in females of childbearing potential
  • ALT/AST < 3 times ULN
  • Recipients in screening must screen negative for SARS-CoV-2 RNA using a PCR-based test
  • Disease Risk Index (DRI) overall risk categorization of intermediate or high
  • Total bilirubin ≤ upper limit of normal (ULN)
  • Estimated glomerular filtration rate (eGFR) ≥ 60 mL/minute

Key Exclusion Criteria:

  • Prior allogeneic HCT
  • Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
  • Planned donor lymphocyte infusion (DLI)
  • Planned pharmaceutical in vivo or ex vivo T cell depletion
  • Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor
  • Karnofsky performance score < 70%
  • Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  • Uncontrolled bacterial, viral or fungal infections at time of enrollment
  • Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, Hepatitis C antibody
  • Known allergy or hypersensitivity to, or intolerance of, tacrolimus
  • Documented allergy or hypersensitivity to iron dextran or bovine, murine, algal or Streptomyces avidinii proteins
  • Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  • Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  • Psychosocial circumstances that preclude the patient being able to go through transplant or participate responsibly in follow up care
  • Women who are pregnant or breastfeeding
  • Women of childbearing potential (WOCBP) or men who have sexual contact with WOCBP unwilling to use effective forms of birth control or abstinence for one year after transplantation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Orca-T
For patients randomized to the Orca-T arm, Orca-T will be administered after myeloablative conditioning regimen. Single-agent GVHD prophylaxis with tacrolimus will be administered following Tcon infusion (generally Day +3).
Biological: Orca-T
an allogeneic stem cell and T-cell immunotherapy biologic
Active Comparator: Standard of Care alloHCT Control
For patients randomized to the standard-of-care control arm, an unmanipulated allograft derived from the peripheral blood of a matched donor will be administered after a myeloablative conditioning regimen. Dual-agent prophylaxis consisting of tacrolimus plus methotrexate will be administered starting on Day -3.
Biological: Standard-of-Care
unmanipulated donor allograft
Other Names:
  • SOC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic Graft-versus-Host-Disease-free Survival
Time Frame: Randomization through 730 days post transplant
An event for this time-to-event outcome is defined as death by any cause or moderate to severe cGVHD as defined by NIH consensus criteria, whichever is earlier.
Randomization through 730 days post transplant

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to moderate or severe cGVHD
Time Frame: Randomization through 730 days post transplant
An event for this time-to-event outcome is defined as time from randomization to the first onset of of moderate or severe cGVHD within 730 days after randomization. Death within 730 days after randomization without prior moderate or severe cGVHD is considered a competing event.
Randomization through 730 days post transplant
Graft-versus-Host Disease and Relapse-free survival (GRFS) up to 1 year
Time Frame: Day 0 through 365 days post-transplant
GRFS is defined as the time from randomization to death from any cause, relapse, the first onset of grade 3 or 4 aGVHD (graded per MAGIC criteria), or the first onset of moderate or severe cGVHD (graded per NIH consensus criteria), whichever is earliest.
Day 0 through 365 days post-transplant
Overall Survival
Time Frame: 730 days after end of enrollment
OS is defined as the time from randomization to death from any cause .
730 days after end of enrollment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Orca Biosystems, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2022

Primary Completion (Estimated)

April 1, 2025

Study Completion (Estimated)

April 1, 2027

Study Registration Dates

First Submitted

March 30, 2022

First Submitted That Met QC Criteria

March 30, 2022

First Posted (Actual)

April 7, 2022

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Precision-T (PhIII component)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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