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

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

A Phase Ib 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

255

Phase

  • Phase 1

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

Study Locations

  • United States
    • California
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Amandeep Salhotra
      • Los Angeles, California, United States, 90095
        • Recruiting
        • Ronald Reagan UCLA Medical Center
        • Contact:
          • Caspian Oliai
      • Sacramento, California, United States, 95817
        • Recruiting
        • UC Davis
        • Contact:
          • Rasmus Hoeg
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford Health Care
        • Contact:
          • Everett Meyer
    • 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
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
          • Rawan Faramand, MD
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Winship Cancer Institute - Emory University
        • Contact:
          • Edmund Waller
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago
        • Contact:
          • Satyajit Kosuri
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Active, not recruiting
        • The University of Kansas Hospital
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts
        • Contact:
          • Yi-Bin Chen, MD
    • 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
    • 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
    • Tennessee
      • Nashville, Tennessee, United States, 37203
        • Recruiting
        • Sarah Cannon Research Institute
        • Contact:
          • Jeremy Pantin
      • Nashville, Tennessee, United States, 37232
        • Recruiting
        • Vanderbilt University
        • Contact:
          • Bhagirathbhai Dholaria
    • Texas
      • Houston, Texas, United States, 77054
        • Active, not recruiting
        • University of Texas MD Anderson Cancer Center
      • San Antonio, Texas, United States, 78229
        • Withdrawn
        • Texas Transplant Institute
    • Utah
      • Salt Lake City, Utah, United States, 84112
        • Recruiting
        • University of Utah - Huntsman Cancer Institute
        • Contact:
          • Sagar Patel

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 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

Recipients must meet all of the following criteria:

  1. Patients must diagnosed with one of the following histopathologically confirmed diseases, for which a myeloablative hematopoietic stem cell transplant (HCT) is planned:

    A) Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia who are not in CR or CRi (active disease) and/or MDS with >10% to <20% bone marrow blast burden (ages 18 to 75 years)

    B) Acute leukemia in CR/CRi or MDS that is DRI intermediate to high risk (ages 66 to 75 years)

    C) BPDCN (ages 18 to 65 years)

    D) Participants aged 18 to 65 who would be eligible for the Phase 3 component of Precision-T except for mild impairments of renal and/or hepatic function as defined by an eGFR of 50 to <60 mL/min and/or a total bilirubin of >ULN to ≤2 x ULN and diagnosed with either of the following:

    i. Acute myeloid, lymphoid, or mixed phenotype/undifferentiated leukemia that is in CR/CRi and DRI intermediate to high risk

    a) MDS that is DRI intermediate to high risk

    E) Acute or chronic leukemia in remission that is DRI low risk (ages 18 to 65 years), including the following:

    i. CML in chronic phase but with a history of accelerated phase or blast crisis or who are resistant to or intolerant of more than 1 first- and second-generation tyrosine kinase inhibitors

    ii. Acute myeloid leukemia (AML) with inv(16) without accompanying complex cytogenetics

  2. Patients must be matched to a 8/8 HLA-matched related or unrelated donor
  3. Estimated glomerular filtration rate (eGFR) > 50 mL/minute
  4. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA)
  5. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%
  6. Total bilirubin < 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included where hemolysis has been excluded) and ALT/AST < 3 times ULN

Key Exclusion Criteria:

Recipients meeting any of the following exclusion criteria will not be eligible:

  1. History of prior allogeneic HCT
  2. Currently receiving corticosteroids or other immunosuppressive therapy. Topical corticosteroids or oral systemic corticosteroid doses less than or equal to 10 mg/day are allowed.
  3. Pre-planned donor lymphocyte infusion (DLI)
  4. Planned pharmaceutical in vivo or ex vivo T cell depletion
  5. Positive for anti-donor HLA antibodies against an allele in the selected donor
  6. Karnofsky performance score < 70%
  7. Hematopoietic cell transplantation-specific Comorbidity Index (HCT-CI) > 4
  8. Uncontrolled bacterial, viral or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment
  9. Seropositive for HIV-1 or -2 antibody, HTLV-1 or -2 antibody, Hepatitis B sAg, or Hepatitis C antibody
  10. Any uncontrolled autoimmune disease requiring active immunosuppressive treatment
  11. Concurrent malignancies or active disease within 1 year, except non-melanoma skin cancers that have been curatively resected
  12. Women who are pregnant or breastfeeding

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects with Acute Leukemia or Myelodysplasic Syndrome, or BPDCN
This is a non-randomized, single-arm study. All enrolled subjects will receive an allogeneic HCT with the Orca-T product.
Biological: Orca-T
an allogeneic stem cell and T-cell immunotherapy biologic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of primary graft failure
Time Frame: 365 days
The incidence of primary graft failure
365 days
The incidence of grade 3 or 4 aGVHD
Time Frame: 180 days
The incidence of grade 3 or 4 aGVHD
180 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
1-year overall survival (OS)
Time Frame: 365 days
1-year overall survival (OS)
365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
Time Frame: 365 days
1 year graft-versus-host-disease-free and relapse-free survival (GRFS)
365 days
incidence and severity of acute and chronic graft vs host disease (GvHD)
Time Frame: 365 days
incidence and severity of acute and chronic graft vs host disease (GvHD)
365 days
incidence of serious infections
Time Frame: 365 days
incidence of serious infections
365 days
incidence of engraftment
Time Frame: 28 days
incidence of engraftment of platelets and neutrophils
28 days

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)

November 21, 2019

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

July 3, 2019

First Submitted That Met QC Criteria

July 8, 2019

First Posted (Actual)

July 10, 2019

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 (PhIb component)

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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