Actively Recruiting

Phase 1
Age: 6Months - 80Years
All Genders
NCT02203903

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

Led by Catherine Bollard · Updated on 2025-05-31

50

Participants Needed

2

Research Sites

651 weeks

Total Duration

On this page

Sponsors

C

Catherine Bollard

Lead Sponsor

C

Children's National Research Institute

Collaborating Sponsor

AI-Summary

What this Trial Is About

This Phase I dose-escalation trial is designed to evaluate the safety of administering rapidly -generated tumor multi-antigen associated -specific cytotoxic T lymphocytes, to HSCT recipients with high risk AML and MDS.

CONDITIONS

Official Title

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

Who Can Participate

Age: 6Months - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Aged 6 months to 80 years.
  • Planned myeloablative or non-myeloablative allogeneic hematopoietic stem cell transplant.
  • High-risk acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients who have received or will receive allo-HSCT without hematologic relapse.
  • Karnofsky or Lansky performance score of 50 or higher.
  • Agree to use contraceptive measures during study participation if age appropriate.
  • Patient or parent/guardian capable of providing informed consent.
  • T cell chimerism greater than 94% if collected from allo-HSCT recipient.
Not Eligible

You will not qualify if you...

  • Uncontrolled infections.
  • Current graft-versus-host disease (GVHD) greater than grade 2, bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
  • Pregnancy (female of childbearing potential).
  • Patients who received anti-thymocyte globulin (ATG), Campath, or other T cell immunosuppressive monoclonal antibodies within 28 days before TAA-T infusion.
  • Use of investigational therapies within 28 days prior to TAA-T infusion.
  • Active acute or chronic GVHD requiring escalation of treatment within the past 2 weeks (for certain study arms).
  • Patients who have or will receive a second allogeneic HSCT.
  • Donation of cells that would pose physical or psychological risk to the donor.
  • Female donors known to be pregnant.

AI-Screening

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Trial Site Locations

Total: 2 locations

1

Childrens National Medical Center

Washington D.C., District of Columbia, United States, 20010

Actively Recruiting

2

Tania Jain, MD

Baltimore, Maryland, United States, 21287

Actively Recruiting

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Research Team

F

Fahmida Hoq, MBBS, MS

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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