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Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT | Clinical Trials | Clareo Health

RECRUITINGPHASE1

Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT

Phase I Trial for Patients With Advanced Hematologic Malignancies Undergoing Allogeneic Hematopoietic Cell Transplantation From an HLA-Mismatched Donor (7/8) With Orca-T

NCT06551584•Stanford University

View on ClinicalTrials.gov

Summary

The study goal is to characterize the safety of the combination of Orca-T with dual agent GVHD prophylaxis.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Eligible diseases:
•* Acute myeloid, lymphoid or mixed phenotype leukemia in complete remission (CR) or CR with incomplete hematologic recovery (CRi) as defined in Section 6.1.3; with or without the presence of known minimal residual disease, or
•* Myelodysplasic syndrome (MDS) myelodysplastic syndromes eligible for alloHSCT and/or treatment-related MDS \<10% blasts
•2. Age ≥ 18 and ≤ 70 years at the time of enrollment.
•3. Eligible for myeloablative alloHCT including one of two the myeloablative conditioning regimens (fractionated total body irradiation plus cyclophosphamide or busulfan, fludarabine, and thiotepa)
•4. Has a related or unrelated donor available who is 7/8 match (single allele mismatched) at HLA-A, -B, -C, and -DRB1, all typed using DNA-based high-resolution methods.
•5. Estimated glomerular filtration rate (eGFR) ≥ 50 mL/minute or creatinine \< 2 mg/dL.
•6. Cardiac ejection fraction at rest ≥ 45% or shortening fraction of ≥ 27% by echocardiogram or radionuclide scan (MUGA).
•7. Diffusing capacity of the lung for carbon monoxide (DLCO) (adjusted for hemoglobin) ≥ 50%.
•8. Total bilirubin \< 2 times upper limit of normal (ULN) (patients with Gilbert's syndrome may be included once hemolysis has been excluded).
+5 more criteria

Exclusion Criteria

•1. 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. Planned donor lymphocyte infusion (DLI).
•4. Planned pharmaceutical in vivo or ex vivo T cell depletion, e.g., post-transplant cyclophosphamide (Cy), peri-transplant anti-thymocyte globulin (ATG), or alemtuzumab. For patients that have previously been exposed to a T cell-depleting agent, a 5 half-life washout of the agent must occur prior to planned Day 0 (day of infusion of Orca-T HSPC and Tregs ).
•5. Recipient positive anti-donor HLA antibodies against a mismatched allele in the selected donor determined by either:
•1. Positive crossmatch test of any titer (by complement-dependent cytotoxicity or flow cytometric testing), or
•2. Presence of anti-donor HLA antibody to any of the following HLA loci: HLA-A, -B, -C, -DRB1, -DQB1, -DQA1, -DPB1, or -DPA1, with mean fluorescence intensity (MFI) \>1000 by solid phase immunoassay.
•6. Uncontrolled bacterial, viral, or fungal infections (currently taking antimicrobial therapy and with progression or no clinical improvement) at time of enrollment including known, active tuberculosis infection.
•7. Seropositive for HIV-1 or -2, HTLV-1 or -2, Hepatitis B sAg, and/or Hepatitis C antibody.
•\*History of hepatitis B or hepatitis C is permitted if viral load is undetectable per quantitative PCR and/or NAT. In this case, monitoring for hepatitis B or hepatitis C by PCR at 3, 6, and 12 months is recommended.
+8 more criteria

Locations (1)

Stanford University

Palo Alto, California, United States

Key Dates

Start Date

December 1, 2025

Primary Completion Date

May 1, 2026

Completion Date

December 1, 2026

Last Updated

January 30, 2026

Enrollment

ESTIMATED participants

Conditions

Acute Myeloid LeukemiaAcute Lymphoid LeukemiaMixed Phenotype Acute LeukemiaMyelodysplastic Syndromes

Interventions

ORCA-T

DRUG

Contacts

Alyssa Kanegai

CONTACT

(650) 736-1596 akanegai@stanford.edu

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 30, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Phase I Trial for Patients w/ Advanced Hematologic Malignancies Undergoing Allogeneic HCT

Inclusion Criteria

Exclusion Criteria

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