Precision-T Study™

A clinical research trial for people with blood cancer who are considering a stem cell transplant

Stem cell transplant is a potentially curative therapy that offers hope for people with blood cancer, but there are risks involved. The Precision-T Study™ is looking at a way to potentially make treatments involving a stem cell transplant safer and more effective than a standard procedure.

Learn about the clinical trial and see if you can take part.

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About the Precision-T Study

The Precision-T Study is testing a way to potentially reduce a serious side effect of allogeneic stem cell transplant called chronic graft versus host disease (GvHD) while keeping the benefits of this treatment. The clinical trial is for people with certain blood cancers, including acute myeloid leukemia, acute lymphoid leukemia and myelodysplastic syndrome.

  • The person with blood cancer (the recipient) receives chemotherapy and/or radiation to further destroy their cancer blood cells and suppress their immune system
  • The recipient’s immune system is then replaced with healthy blood cells from another person (the donor)
  • Healthy blood (called the graft) contains many different types of cells—some can provide benefit, but some may cause GvHD by attacking cells of the recipient (also called the host)

This clinical trial is looking to see if giving the recipient only certain types of healthy blood cells improves chronic GvHD survival. Healthy blood cells from the donor will be used to manufacture the investigational cell therapy, currently called Orca-T. Recipients will be given Orca-T in a similar way as a standard cell therapy.

People with blood cancer who take part in the clinical research trial will receive:

  • Either Orca-T or a standard cell therapy, and
  • Other medicines to help reduce the chance of developing certain side effects

Donors involved in the study will give their blood via apheresis, a standard process for collecting blood cells for stem cell transplant.

To learn more about the Precision-T Study design, visit ClinicalTrials.gov.

After stem cell transplant, study investigators will monitor and manage the recipient to see if their blood cancer comes back and see if any side effects develop from the stem cell transplant, including GvHD and infection. This information will be used to see how long people are living free of chronic GvHD, as well as how long it takes for GvHD to develop (if at all) and, for how many people.

More details about the questions being studied can be found at ClinicalTrials.gov..

Who can take part
in the Precision-T Study?

To become a recipient of a stem cell transplant in this clinical trial, you must:

  • Be 18 to 65 years old
  • Have a certain type of blood cancer (acute myeloid leukemia, acute lymphoid leukemia, myelodysplastic syndrome)
  • Be planning on getting a stem cell transplant, as determined by your doctor
  • Have identified a healthy donor, who may be a relative or unrelated donor

People who have already had a stem cell transplant will not be able to take part.

If you are interested in taking part, talk with your doctor or a study investigator about the clinical trial, as there are other criteria for entry, to help decide if it is right for you.

If you are a donor and have questions about the trial, please see the frequently asked questions section below. Unrelated donors who were matched to the recipient via the National Marrow Donor Program may contact their donation center for more information. Related donors may contact a study investigator for more information.

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Frequently Asked Questions

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What is a clinical trial?

A clinical trial is a type of research study that tests if an investigational therapy is safe and works in people. The US Food and Drug Administration (FDA) has strict rules on how clinical trials are performed and reviews the data produced from it to decide if that investigational therapy can be widely used. Clinical trials typically follow a series of phases (Phase 1, 2, and 3) where increasing numbers of people are studied, often for increasing lengths of time, to make sure the investigational therapy is safe and effective.

Why participate in a clinical trial?

People choose to take part in clinical trials for different reasons, including being able to:

  • Access new or currently approved therapies
  • Receive additional medical care and attention
  • Take an active role in your health and wellbeing
  • Help shape the future treatment of your disease

You should also consider the following:

  • You may have side effects from the investigational therapy
  • The investigational therapy may have little, if any, benefit
  • The clinical trial will require time for traveling to the study site and for office visits

How does a clinical trial work?

A clinical trial involves a set of clinic visits, tests, and procedures that you must follow if you decide to enroll. Information about how you are responding to the investigational therapy and how you feel is collected. Once information from enough people is collected, the study investigators will look at the findings.

What is an investigational therapy?

An investigational therapy is a treatment for a disease that is not currently approved by the US Food and Drug Administration (FDA) for wider use. It is given to people taking part in a clinical trial to learn if it is safe and effective. The FDA needs to review data on the investigational therapy before any clinical trial can start. Then, once the study investigators have enough information from clinical trials, the FDA will review this additional information and determine if it can be approved for wider use by doctors.

What is Orca-T?

Orca-T is the current name of an investigational therapy that contains a specific set of blood cells from a healthy donor. Orca-T is given to the recipient in a similar way as standard cell therapy. For comparison purposes, some people on the Precision-T Study will receive a standard cell therapy instead of Orca-T. The Precision-T Study is a large study that was started based on encouraging results from an earlier clinical study. Information on this study can be found at OrcaBio.com.

Why is chronic GvHD a serious problem?

GvHD is a common side effect that can happen after stem cell transplant. It occurs when healthy blood cells from the donor (the graft), which were given to replace cancer blood cells, attack organs of the recipient (the host). This can change the way these organs work and may increase the chance of infection. Symptoms of GvHD range from mild to serious and may even be life-threatening.

Doctors call GvHD either acute or chronic. Acute GvHD happens shortly after transplant and may only last a short time. Chronic GvHD happens much later after transplant and can last a long time. It is possible to get both acute and chronic GvHD. The goal of the Precision-T Study is to see if the investigational therapy, Orca-T, can reduce the chance that chronic GvHD happens while keeping the benefits of stem cell transplant. Information from an earlier study can be reviewed at OrcaBio.com.

Are there any concerns for donors?

A donor’s role in the Precision-T Study will be very similar to that of a regular allogeneic stem cell transplant. The donor will give blood in the standard way via apheresis, a standard process for collecting blood cells for this type of procedure. Blood cells will be either used as a standard cell therapy or used to manufacture Orca-T, the investigational therapy. The blood will be handled with the utmost care from donation to infusion, and recipients will be closely monitored after transplant. The Precision-T Study follows on from an earlier study of Orca-T. Information on this study can be found at OrcaBio.com.

Clinical trials are extremely important as they look for ways to make therapies safer and more effective. For a recipient to join the Precision-T Strudy, the donor must also agree to take part. If you have any questions, please contact your donation center, or talk to a study investigator.

How can I learn more?

If you are interested in the clinical trial but have not enrolled, contact your doctor for information. You can also learn more at ClinicalTrials.gov.

If you are enrolled in the clinical trial, one of the study investigators will answer any questions that you may have.

Study locations

Current US study locations are listed below, and more may be added as they open. If you don’t see a study location for your area, visit ClinicalTrials.gov to see if a local study location has been added.

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California

Stanford Health Care
Stanford, California, United States, 94305
Contact: Everett Meyer, MD, PhD
Contact: Lindsay Danley
lindsmd@stanford.edu

City of Hope
Duarte, California, United States, 91010
Contact: Amandeep Salhotra, MD

Ronald Reagan UCLA Medical Center
Los Angeles, California, United States, 90095
Contact: Caspian Oliai, MD
Contact: Bruck Habtemariam
bhabtemariam@mednet.ucla.edu

University of California, Davis
Sacramento, California, United States, 95817
Contact: Rasmus Hoeg, MD
Contact: Dara Feleciano, RN MSN
djfeleciano@ucdavis.edu

Colorado

Colorado Blood Cancer Institute
Denver, Colorado, United States, 80218
Contact: Alireza Eghtedar, MD (720) 754-4800

Florida

University of Miami Hospital and Clinics – Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
Contact: Antonio Jimenez, MD

Moffitt Cancer Center
Tampa, Florida, United States, 33612
Contact: Rawan Faramand, MD
Rawan.Faramand@moffitt.org

Georgia

Winship Cancer Institute – Emory University
Atlanta, Georgia, United States, 30322
Contact: Edmund Waller, MD, PhD

Illinois

University of Chicago Medical Center
Chicago, Illinois, United States, 60637
Contact: Satyajit Kosuri, MD

Massachusetts

Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Contact: Yi-Bin Chen, MD
ychen6@partners.org

Michigan

University of Michigan Health System – Michigan Medicine
Ann Arbor, Michigan, United States, 48109
Contact: Cancer Center Hotline (800) 865-1125
Principal Investigator: John Magenau, MD

New York

Weill Cornell Medicine – New York-Presbyterian Hospital
New York, New York, United States, 10021
Contact: Alexandra Gomez Arteaga, MD
Contact: Meredith Mullane, RN
Met9042@med.cornell.edu

Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Contact: Roni Tamari, MD
abmttrials@mskcc.org

Ohio

Cleveland Clinic
Cleveland, Ohio, United States, 44195
Contact: Betty Ky Hamilton, MD
taussigresearch@ccf.org
(216) 444-7923

Oklahoma

OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, United States, 73104
Contact: Jennifer Holter-Chakrabarty, MD (405) 271-8299
Contact: Silas Day (405) 271-8001 *48748

Oregon

Oregon Health & Sciences University – Knight Cancer Institute
Portland, Oregon, United States, 97239
Contact: Arpita Gandhi, MD

Tennessee

Sarah Cannon Research Institute
Nashville, Tennessee, United States, 37239
Contact: Jeremy Pantin, MD

Vanderbilt University
Nashville, Tennessee, United States, 37232
Contact: Bhagirathbhai Dholaria, MD
Contact: Rohan Goel
rohan.w.goel@vumc.org

Utah

University of Utah
Salt Lake City, Utah, United States 84112
Contact: Sagar Patel, MD
Contact: Collind Boyington
collind.boyington@hci.utah.edu

Precision-T Study Locations
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Contact us

For more information about the Precision-T Study:
clinicaltrials@orcabio.com
ClinicalTrials.gov
If you are a doctor interested in learning more about the Orca-T and the Precision-T Study, visit ClinicalTrials.gov to see clinical trial details and OrcaBio.com to review information from an earlier study.