NCT02494167

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

Active, enrolled Phase 1 Last updated 20 October 2025

What this trial tests

Phase 1 trial testing MultiTAA-specific T cells in Acute Myeloid Leukemia in 44 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

1 February 2016

Primary endpoint
1 April 2025

1 February 2027

Quick facts

Lead sponsor	Baylor College of Medicine
Phase	Phase 1
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	non randomized
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	44
Start date	1 February 2016
Primary completion	1 April 2025
Estimated completion	1 February 2027
Sites	2 locations across United States

Drugs / interventions tested

• MultiTAA-specific T cells — full drug profile →

Conditions studied

• Acute Myeloid Leukemia — all drugs for Acute Myeloid Leukemia →
• Myelodysplastic Syndrome — all drugs for Myelodysplastic Syndrome →

Sponsor

Baylor College of Medicine

Who can join

Eligibility, any sex, with Acute Myeloid Leukemia or Myelodysplastic Syndrome. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• Number of patients with dose-limiting toxicities (DLTs).
  Time frame: 4 weeks
  Maximum tolerated dose (MTD) of multiTAA-specific T cells among the five pre-specified dose levels.

Sponsor's own 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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. NY-ESO-1 Based Immunotherapy of Cancer: Current Perspectives.
   Thomas R, Al-Khadairi G, Roelands J, Hendrickx W, et al · · 2018 · cited 298× · PMID 29770138 · DOI 10.3389/fimmu.2018.00947
2. Cancer Testis Antigens and Immunotherapy: Where Do We Stand in the Targeting of PRAME?
   Al-Khadairi G, Decock J. · · 2019 · cited 85× · PMID 31311081 · DOI 10.3390/cancers11070984
3. Immuno-transcriptomic profiling of extracranial pediatric solid malignancies.
   Brohl AS, Sindiri S, Wei JS, Milewski D, et al · · 2021 · cited 60× · PMID 34818552 · DOI 10.1016/j.celrep.2021.110047
4. The twisted survivin connection to angiogenesis.
   Sanhueza C, Wehinger S, Castillo Bennett J, Valenzuela M, et al · · 2015 · cited 56× · PMID 26584646 · DOI 10.1186/s12943-015-0467-1
5. Clinical effects of administering leukemia-specific donor T cells to patients with AML/MDS after allogeneic transplant.
   Lulla PD, Naik S, Vasileiou S, Tzannou I, et al · · 2021 · cited 51× · PMID 33270816 · DOI 10.1182/blood.2020009471
6. Biology of Cancer-Testis Antigens and Their Therapeutic Implications in Cancer.
   Nin DS, Deng LW. · · 2023 · cited 45× · PMID 36980267 · DOI 10.3390/cells12060926
7. Acute myeloid leukemia immunopeptidome reveals HLA presentation of mutated nucleophosmin.
   Narayan R, Olsson N, Wagar LE, Medeiros BC, et al · · 2019 · cited 43× · PMID 31291378 · DOI 10.1371/journal.pone.0219547
8. T-Cell Immunotherapies Targeting Histocompatibility and Tumor Antigens in Hematological Malignancies.
   Janelle V, Rulleau C, Del Testa S, Carli C, et al · · 2020 · cited 36× · PMID 32153583 · DOI 10.3389/fimmu.2020.00276