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Multi-antigen Specifically Oriented Lymphocytes for High-Risk Blood Cancers

This study is testing the safety of a treatment called Tumor Associated Antigen Lymphocytes (TAA-T) for people with very high-risk blood cancers like Acute Myeloid Leukemia (AML) and Myelodysplastic Syndrome (MDS). TAA-T are special immune cells designed to find and kill cancer cells. These cells are made to target three specific cancer markers (WT1, PRAME, and SURVIVIN). You might be able to join if you are between 6 months and 80 years old, have high-risk AML or MDS, and have had or will have a stem cell transplant. The main goal is to see how safe TAA-T is, with safety being measured at 45 days after treatment. The study plans to enroll 50 participants, but its current status is unclear.

Study design
This is a Phase I dose-escalation study, meaning it starts with a low dose and gradually increases it to find the safest and most effective amount. It plans to enroll 50 participants.
What's involved
You would receive an infusion of TAA-T cells after your stem cell transplant. You would be monitored for side effects.
Compensation
Not stated in the trial record.
Follow-up
Safety will be measured at 45 days after the TAA-T infusion.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT02203903

Multi-institutional Prospective Research of Expanded Multi-antigen Specifically Oriented Lymphocytes for the Treatment of VEry High Risk Hematopoietic Malignancies

Recruiting
PHASE1Ages 6–80InterventionalTreatment
Catherine Bollard
~50 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:Tumor associated antigen lymphocytes (TAA-T)

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Safety of investigational product (TAA-T)
Measured over 45 days
+3 more outcomes measured

Conditions

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS

Explore related trials

Acute Myeloid LeukemiaHematologic NeoplasmMyelodysplastic SyndromeT cell chimerismTotal chimerism

Where it's being run

2 sites across 2 states
District of Columbia1
Maryland1

Who to contact

Fahmida Hoq, MBBS, MS
[email protected]
202-476-3634
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Aged 6 months to 80 years.
Anticipated myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant.
Patients with high risk AML and MDS who have received or will receive an allo-HSCT and have not had hematologic relapse of disease.
Karnofsky/Lansky score of ≥ 50.
Agree to use contraceptive measures during study protocol participation (when age appropriate).
Patient or parent/guardian capable of providing informed consent.
T cell chimerism \> 94% if collected from recipient of allo-HSCT
Patients with high risk AML and MDS who have received an allo-HSCT and have not had hematologic relapse of disease.
Steroids less than 0.5 mg/kg/day prednisone or equivalent in the context of no escalation of treatment within the preceding 2 weeks
Karnofsky/Lansky score of ≥ 50.
Bilirubin \< 2.5 mg/dL, AST/ALT \<5x upper limit of normal, Serum creatinine \< 1.0 or 2x the upper limit of normal (whichever is higher).
Pulse oximetry of \> 90% on room air.
Absolute neutrophil count \> 250/ µL (may be supported with Granulocyte colony-stimulating factor (GCSF)).
Agree to use contraceptive measures during study protocol participation (when age appropriate).
Patient or parent/guardian capable of providing informed consent.
LVEF \> 50% or LVSF \> 27% (performed within the last 6 months) if history of TBI \>500 cGy for arm A and B.
Total chimerism \> 50%; or if cancer cells preclude this, donor T cell chimerism \> 50% (performed within the last 6 months).
Donors for allogeneic (i.e. HLA matched or mismatched related or unrelated) stem cell transplants who have undergone eligibility evaluation as per FDA regulations outlined in 21 CFR 1271 subpart C. If a donor has been chosen for the transplant based on urgent medical need, that same donor will also be used for TAA-T generation provided that there are no new reasons for ineligibility since the transplant donor evaluation.
Aged 6 months to 80 years.
Donor or guardian of pediatric capable of providing informed consent.
Donor must have completed infectious Disease (ID) testing up to 7 days before or after the collection of blood from the donor (related or unrelated) for TAA-T manufacturing. The following tests will be performed:
HBsAg
HB Core antibody
HIV1/2 NAT
Syphilis (T. Pallidum IgG)
HTLV I/II
CMV total
HBV/HCV NAT
West Nile Virus NAT.
Cruz (Chagas) antibody
Hepatitis C
Female donors of childbearing age must have a negative pregnancy test within 7 days of blood collection for TAA-T manufacturing.

Exclusion

Patients with uncontrolled infections.
Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
Pregnancy (female of childbearing potential).
Patients who received ATG, Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days prior to TAA-T infusion.
No investigational therapies (under IND, not extensively studied in the current clinical context) within 28 days prior to TAA-T infusion.
Uncontrolled infections.
Active Bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
Active acute GVHD or chronic GVHD requiring escalation of treatment within preceding 2 weeks of any grade is exclusion for Arm C patients.
Pregnancy or lactating (female of childbearing potential).
Patients who have or will be receiving 2nd allogeneic HSCT
Donation of cells would pose a physical or psychological risk to the donor.
Female donors of childbearing age who are known to be pregnant.

What this trial measures

  • Safety of investigational product (TAA-T)45 days

    Acute GVHD grades III-IV within 45 days of the last dose of TAA-T

  • Safety of TAA-T cells45 days

    Grades 3-5 infusion-related adverse events within 45 days of the last dose of TAA-T

  • Safety of TAA-Ts45 days

    Grades 4-5 non-hematological attributable adverse events within 45 days of TAA-T dose and that are not due to the pre-existing infection or the original malignancy or pre-existing co-morbidities as defined by the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), Version 5.0

  • Event-free survivalTwelve months post-HSCT

    To determine if event-free survival (EFS) at twelve months post-HSCT is improved with TAA-T administration for AML and MDS (Arm C).