Hematologic MalignanciesNCT07346105
Orca-T Expanded Access Program Study for Patients With Advanced Hematologic Malignancies
A study testing Orca-T in people with Hematologic Malignancies and Acute Myeloid Leukemia, run by Orca Biosystems, Inc. at 8 sites in United States.
Trial summary
This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoid Leukemia
- What is being tested?
- Orca-T
- How many people
- Not given
- Where
- 8 sitesUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Child, Adult, Older adult
Who may be able to join
- Recipients in this EAP must meet all of the following criteria:
- Commercial Orca-T was prescribed to the patient by their treating physician.
- The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.
- The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.
- Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
- Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.
Who cannot join
- Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
- Available
Massachusetts General Hospital
Boston, Massachusetts, 02114
Richard Newcomb, MD
- Available
The Ohio State University Wexner Medical Center - James Cancer Hospital
Columbus, Ohio, 43210
Sarah Wall, MD, MPH
- Available
Baylor University Medical Center
Dallas, Texas, 75246
Jana Reynolds, MD
- Available
The University of Kansas Hospital
Kansas City, Kansas, 66160
Joseph McGuirk, DO, FACP
- Available
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
Caspian Oliai, MD
- Available
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
Roni Tamari, MD, MS
- Available
Stanford Cancer Institute
Palo Alto, California, 94304
Andrew Rezvani, MD
- Available
Moffitt Cancer Center
Tampa, Florida, 33612
Nelli Benjanyan, MD
About this study
Official title: An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release
This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.
- Conditions
- Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Mixed Phenotype Acute Leukemia
- Being tested
- Orca-T
- Keywords
- Hematopoietic stem cell transplantation, Acute leukemia, Myelodysplastic syndromes, Matched related donor, Matched unrelated donor, Myelodysplastic syndrome, TREGZI
- Medical subject headings
- Hematologic Neoplasms, Leukemia, Myeloid, Acute, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Myelodysplastic Syndromes, Leukemia, Biphenotypic, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Orca-TBiological
Orca-T that does not meet commercial release specifications
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hematologic MalignanciesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Orca Biosystems, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07346105
- Sponsor's protocol ID
- TREGZI (Orca-T) OOS EAP
- Status last verified
- Sep 2026
- First submitted
- 7 Jan 2026
- Last updated
- 21 Sep 2026
- Results posted
- No
Publications
Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.
PubMed 41385341
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Expanded Access Program for Orca-T Products That Are Out of Specification for Commercial Release
- ClinicalTrials.gov ID
- NCT07346105
- Acronym / sponsor ID
- TREGZI (Orca-T) OOS EAP
- Conditions
- Hematologic Malignancies, Acute Myeloid Leukemia, Acute Lymphoid Leukemia, Myelodysplastic Syndrome, Mixed Phenotype Acute Leukemia
- Keywords
- Hematopoietic stem cell transplantation, Acute leukemia, Myelodysplastic syndromes, Matched related donor, Matched unrelated donor, Myelodysplastic syndrome, TREGZI
- Study type
- Expanded access
- Recruitment status
- Available
- Lead sponsor
- Orca Biosystems, Inc.Industry (pharma, biotech, devices)
- First posted
- 16 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is not designed to test a hypothesis; rather, this study will provide patients with access to Orca-T if the commercial Orca-T product produced for them is deemed out of specification (OOS). Serious adverse events (SAEs) occurring during the safety reporting period (defined as the day the recipient receives the Orca-T HSPC drug product through day +365 after transplantation or until initiation of new anticancer therapy, whichever occurs sooner) will be reported.
Study design
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Commercial Orca-T was prescribed to the patient by their treating physician.
- The final manufactured Orca-T does not meet the commercial release specifications or is delivered past expiry.
- The final manufactured Orca-T is acceptable per joint assessment by Orca Bio and the treating physician, taking into account Orca Bio's release criteria.
- Remanufacturing (ie, repeat leukapheresis and manufacturing) is not clinically appropriate per the treating physician's assessment.
- Recipient must be deemed medically fit and stable to receive Orca-T infusions per the treating physician's evaluation.
Key exclusion criteria (1 listed)
- Recipients with any medical condition identified by the treating physician that may impact the safety or outcomes of the recipient in relation to treatment with Orca-T will not be eligible.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Orca-TOrca-T that does not meet commercial release specifications | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Background: PubMed 41385341Meyer EH, Salhotra A, Gandhi AP, Pantin J, Patel SS, Hoeg RT, Gomez-Arteaga A, Faramand R, Tamari R, Waller EK, Kosuri S, Jimenez Jimenez AM, Holter-Chakrabarty J, Dholaria B, Chen YB, Hamilton BK, Magenau J, Eghtedar A, Murray JM, Pavlova A, Fernhoff NB, McClellan JS, Killian MS, Li A, Negrin RS, Oliai C. Orca-T vs allogeneic hematopoietic stem cell transplantation (Precision-T): a multicenter, randomized phase 3 trial. Blood. 2026 Mar 12;147(11):1168-1177. doi: 10.1182/blood.2025031313.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orca-T in people with Hematologic Malignancies and Acute Myeloid Leukemia, run by Orca Biosystems, Inc. at 8 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact James S. McClellan, MD, PhD (530-414-9723, info@orcabio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07346105, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.