ACTIVE_NOT_RECRUITING

Administration of Donor Multi TAA-Specific T Cells for AML or MDS (ADSPAM)

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This research study uses special blood cells called multiple tumor-associated antigen (TAA)-specific T cells (a new experimental therapy) to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) which has come back, or may come back, or has not gone away after standard treatment, including an allogeneic hematopoietic stem cell transplant (HSCT). The investigators have previously used this sort of therapy to treat Hodgkin or non-Hodgkin lymphomas that are infected with Epstein-Barr virus (EBV). EBV is found in cancer cells of up to half of all patients with Hodgkin and non-Hodgkin lymphoma. This suggests that it may play a role in causing lymphoma. The cancer cells infected by EBV are able to hide from the body's immune system and escape being killed. The investigators previously tested whether special white blood cells (called T cells) that were trained to kill EBV-infected cells could affect these tumors, and in many patients the investigators found that giving these trained T cells causes a complete or partial response. Other cancers express specific proteins that can be targeted in the same way. The investigators have been able to infuse such tumor-targeted cells into up to 10 patients with lymphoma who do not have EBV, and seen some complete responses. Importantly, the treatment appears to be safe. Therefore, the investigators now want to test whether the investigators can direct these special T cells against other types of cancers that carry similar proteins called tumor-associated antigens (TAAs). These proteins are specific to the cancer cell, so they either do not show up, or show up in low quantities, or normal human cells. The investigators will grow T cells from patients' stem cell donors in the laboratory in a way that will train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin, which are expressed on most AML and MDS cancer cells. The cells will be infused at least 30 days post-allogeneic stem cell transplant. In this study, the investigators want see whether these cells will be able to recognize and kill cancer cells that express these proteins. These donor-derived multiTAA-specific T cells are an investigational product not yet approved by the U.S. Food and Drug Administration The purpose of this study is to find the largest safe dose of donor-derived tumor protein multiTAA-specific T cells for patients with AML or MDS.

Official Title

Administration of Donor Derived Multi-Tumor-Associated Antigen (TAA)- Specific T Cells to Patients With AML or MDS (ADSPAM)

Quick Facts

Study Start:2016-02
Study Completion:2027-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT02494167

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as;
  2. 2. Life expectancy ≥ 6 weeks.
  3. 3. Karnofsky/Lansky score of ≥ 50.
  4. 4. Patient or parent/guardian capable of providing informed consent.
  5. 5. Bilirubin ≤ 2X upper limit of normal.
  6. 6. AST ≤ 3X upper limit of normal.
  7. 7. Undergoing stem cell transplant at CAGT.
  8. 8. Serum creatinine ≤ 2X upper limit of normal.
  9. 9. Hgb ≥ 7.0 g/dL (can be transfused).
  10. 10. Pulse oximetry of \> 90% on room air.
  11. 11. Sexually active patients must be willing to utilize one of the more effective birth control methods for 6 months after the T cell infusion. Male partner should use a condom.
  12. 12. Available donor-derived multiTAA-specific T cell line.
  13. 13. No other investigational anti-neoplastic therapy for one month prior to entry in this study.
  1. 1. Patients receiving ATG or Campath within 28 days of infusion.
  2. 2. Patients receiving a Donor Lymphocyte Infusion within 4 weeks of planned T cell infusion.
  3. 3. Less than 30 days post-allogeneic stem cell transplant.
  4. 4. Severe intercurrent infection.
  5. 5. Evidence of GVHD \> Grade II.
  6. 6. Pregnant or lactating.
  7. 7. Currently taking corticosteroids (\> 0.5 mg/kg/day prednisone or equivalent).

Contacts and Locations

Principal Investigator

Premal Lulla, MD
PRINCIPAL_INVESTIGATOR
Baylor College of Medicine

Study Locations (Sites)

Houston Methodist Hospital
Houston, Texas, 77030
United States
Texas Children's Hospital
Houston, Texas, 77030
United States

Collaborators and Investigators

Sponsor: Baylor College of Medicine

  • Premal Lulla, MD, PRINCIPAL_INVESTIGATOR, Baylor College of Medicine

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2016-02
Study Completion Date2027-02

Study Record Updates

Study Start Date2016-02
Study Completion Date2027-02

Terms related to this study

Keywords Provided by Researchers

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome
  • MultiTAA Specific T cells

Additional Relevant MeSH Terms

  • Acute Myeloid Leukemia
  • Myelodysplastic Syndrome