NCT02203903

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_1

Timeline
14mo left

Started Jan 2015

Longer than P75 for phase_1

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress91%
Jan 2015Jun 2027

First Submitted

Initial submission to the registry

July 25, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 30, 2014

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
11.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2027

Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

11.9 years

First QC Date

July 25, 2014

Last Update Submit

May 29, 2025

Conditions

Relapsed/Refractory Hematopoietic Malignancies, Acute Myeloid Leukemia and MDS

Outcome Measures

Primary Outcomes (4)

  • Safety of investigational product (TAA-T)

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

    45 days

  • Safety of TAA-T cells

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

    45 days

  • Safety of TAA-Ts

    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

    45 days

  • Event-free survival

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

    Twelve months post-HSCT

Secondary Outcomes (1)

  • Tumor associated antigen lymphocytes (TAA-T) responses

    2 years

Other Outcomes (5)

  • The incidence and severity of acute and/or chronic GVHD

    2 years

  • Event free and overall survival

    1 year

  • Characterize the cytokine and lymphocyte cellular milieu pre- and post-infusion of TAA-T

    2 years

  • +2 more other outcomes

Study Arms (1)

Tumor associated antigen lymphocytes (TAA-T)

EXPERIMENTAL

TAA-T will be infused any time after neutrophil engraftment post-HSCT or day 30, whichever comes first. All infusions will be within 5 months post-HSCT. Patients will receive a TAA-T cell dose of 4 x 107 cells/m2.

Biological: Tumor associated antigen lymphocytes (TAA-T)

Interventions

Tumor associated antigen lymphocytes (TAA-T)BIOLOGICAL

TAA-T may be generated from donors or recipients and will be tested for specificity to 3 tumor antigens commonly found in hematological malignancies (WT1, PRAME, and SURVIVIN,). The goal of this cell infusion will be to initiate an immune response to residual leukemia or lymphoma that includes multiple antigens and may prevent tumor evasion (through decreased expression of a single antigen).

Tumor associated antigen lymphocytes (TAA-T)

Eligibility Criteria

Age6 Months - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with uncontrolled infections.
  • Current evidence of GVHD \> grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis.
  • Pregnancy (female of childbearing potential).
  • 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).
  • 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.
  • +21 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Childrens National Medical Center

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

RECRUITING

Tania Jain, MD

Baltimore, Maryland, 21287, United States

RECRUITING

Related Publications (1)

  • Kinoshita H, Cooke KR, Grant M, Stanojevic M, Cruz CR, Keller M, Fortiz MF, Hoq F, Lang H, Barrett AJ, Liang H, Tanna J, Zhang N, Shibli A, Datar A, Fulton K, Kukadiya D, Zhang A, Williams KM, Dave H, Dome JS, Jacobsohn D, Hanley PJ, Jones RJ, Bollard CM. Outcome of donor-derived TAA-T cell therapy in patients with high-risk or relapsed acute leukemia post allogeneic BMT. Blood Adv. 2022 Apr 26;6(8):2520-2534. doi: 10.1182/bloodadvances.2021006831.

    PMID: 35244681DERIVED

MeSH Terms

Conditions

RecurrenceHematologic NeoplasmsLeukemia, Myeloid, Acute

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNeoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic DiseasesLeukemia, MyeloidLeukemiaNeoplasms by Histologic Type

Central Study Contacts

Fahmida Hoq, MBBS, MS

CONTACT

202-476-3634fhoq@childrensnational.org

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director- Center for Cancer and Immunology Research

Study Record Dates

First Submitted

July 25, 2014

First Posted

July 30, 2014

Study Start

January 1, 2015

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

June 28, 2027

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations

US(2)