Precision-T: A Randomized Phase III Study of Orca-T in Recipients Undergoing Allogeneic Transplantation for Hematologic Malignancies (Orca-T)
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| ClinicalTrials.gov Identifier: NCT05316701 |
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Recruitment Status :
Recruiting
First Posted : April 7, 2022
Last Update Posted : January 26, 2023
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Sponsor:
Orca Biosystems, Inc.
Information provided by (Responsible Party):
Orca Biosystems, Inc.
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Brief Summary:
This study will compare the safety and efficacy between patients receiving an engineered donor graft ("Orca-T", a T-cell-Depleted Graft With Additional Infusion of Conventional T Cells and Regulatory T Cells) or standard-of-care (SOC) control in participants undergoing myeloablative allogeneic hematopoietic cell transplant transplantation (MA-alloHCT) for hematologic malignancies. This posting represents the Phase III component of Precision-T. The Precision-T Ph1b component is described under NCT04013685.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myeloid Leukemia Acute Lymphoid Leukemia Mixed Phenotype Acute Leukemia Undifferentiated Leukemia High-risk Myelodysplastic Syndrome Acute Leukemia Therapy-Related Myelodysplastic Syndrome MDS | Biological: Orca-T Biological: Standard-of-Care | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 174 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | The Phase III is a randomized, open-label, multicenter study comparing outcomes between patients receiving Orca-T followed by single-agent tacrolimus or standard-of-care (SOC) control followed by dual agent, tacrolimus-based Graft-versus-Host-Disease (GVHD) prophylaxis regimen |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | June 21, 2022 |
| Estimated Primary Completion Date : | April 2024 |
| Estimated Study Completion Date : | April 2028 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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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).
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Biological: Orca-T
engineered donor allograft
Other Name: TregGraft |
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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.
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Biological: Standard-of-Care
unmanipulated donor allograft
Other Name: SOC |
Primary Outcome Measures :
- 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
Secondary Outcome Measures :
- Graft-versus-Host-Disease and Relapse-free survival (GRFS) [ Time Frame: Day 0 through 365 days post-transplant ]An event for this time-to-event outcome is defined as survival free of death from any cause, relapse, Grade 3-4 aGVHD (graded per MAGIC), and moderate to severe cGVHD (graded per NIH consensus criteria).
- Moderate to severe chronic graft-versus-host-disease [ Time Frame: Day 0 through 365 days post-transplant ]An event for this time-to-event outcome is defined as moderate to severe cGVHD as defined by NIH consensus criteria.
- Relapse-free survival [ Time Frame: Day 0 through 730 days post-transplant ]Survival free of death from relapse.
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Key Inclusion Criteria:
- Matched to a related or unrelated donor who is an 8/8 match for HLA-A, -B, -C, and DRB1
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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
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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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05316701
Contacts
| Contact: James S McClellan, MD PhD | 530 414 9743 | info@orcabio.com |
Locations
| United States, California | |
| City of Hope | Recruiting |
| Duarte, California, United States, 91010 | |
| Contact: Amandeep Salhotra | |
| Ronald Regan UCLA Medical Center | Recruiting |
| Los Angeles, California, United States, 90095 | |
| Contact: Caspian Oliai, MD | |
| Contact: Bruck Habtemariam BHabtemariam@mednet.ucla.edu | |
| UC Davis | Recruiting |
| Sacramento, California, United States, 95817 | |
| Contact: Rasmus Hoeg | |
| Contact: Dara Feleciano, RN MSN djfeleciano@ucdavis.edu | |
| Stanford Health Care | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Everett Meyer, MD, PhD | |
| Contact: Lindsay Danley lindsmd@stanford.edu | |
| United States, Florida | |
| University of Miami Hospital and Clinics - Sylvester Comprehensive Cancer Center | Recruiting |
| Miami, Florida, United States, 33136 | |
| Contact: Antonio M Jimenez, MD | |
| Moffitt Cancer Center | Recruiting |
| Tampa, Florida, United States, 33612 | |
| Contact: Rawan Faramand, MD 888-663-3488 Rawan.Faramand@moffitt.org | |
| United States, Georgia | |
| Winship Cancer Institute - Emory University | Recruiting |
| Atlanta, Georgia, United States, 30322 | |
| Contact: Edmund Waller, MD, PhD | |
| United States, Illinois | |
| University of Chicago | Recruiting |
| Chicago, Illinois, United States, 60637 | |
| Contact: Satyajit Kosuri, MD | |
| United States, Massachusetts | |
| Massachusetts General Hospital | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Yi-Bin Chen, MD 617-724-3456 ychen6@partners.org | |
| United States, New York | |
| Weill Cornell Medicine - New York-Presbyterian Hospital | Recruiting |
| New York, New York, United States, 10021 | |
| Contact: Alexandra Gomez Arteaga, MD | |
| Contact: Meredith Mullane, RN 212-746-0702 Met9042@med.cornell.edu | |
| United States, Oregon | |
| Oregon Health & Sciences University - Knight Cancer Institute | Recruiting |
| Portland, Oregon, United States, 97239 | |
| Contact: Arpita Gandhi, MD | |
| United States, Tennessee | |
| Vanderbilt University | Recruiting |
| Nashville, Tennessee, United States, 37232 | |
| Contact: Bhagirathbhai Dholaria, MD 615-343-6653 | |
| Contact: Rohan Goel rohan.w.goel@vumc.org | |
| Sarah Cannon Research Institute | Recruiting |
| Nashville, Tennessee, United States, 37239 | |
| Contact: Jeremy Pantin, MD 615-342-3385 | |
| United States, Utah | |
| University of Utah | Recruiting |
| Salt Lake City, Utah, United States, 84112 | |
| Contact: Sagar Patel, MD | |
| Contact: Collind Boyington Collind.boyington@hci.utah.edu | |
Sponsors and Collaborators
Orca Biosystems, Inc.
| Responsible Party: | Orca Biosystems, Inc. |
| ClinicalTrials.gov Identifier: | NCT05316701 |
| Other Study ID Numbers: |
Precision-T (PhIII component) |
| First Posted: | April 7, 2022 Key Record Dates |
| Last Update Posted: | January 26, 2023 |
| Last Verified: | January 2023 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by Orca Biosystems, Inc.:
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hematopoietic stem cell transplantation acute leukemia Myelodysplastic syndromes |
matched related donor matched unrelated donor myelodysplastic syndrome |
Additional relevant MeSH terms:
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Leukemia Preleukemia Hematologic Neoplasms Leukemia, Lymphoid Precursor Cell Lymphoblastic Leukemia-Lymphoma Myelodysplastic Syndromes Syndrome Acute Disease Disease Pathologic Processes Neoplasms by Histologic Type |
Neoplasms Bone Marrow Diseases Hematologic Diseases Precancerous Conditions Neoplasms by Site Disease Attributes Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |