MULTI TUMOR-ASSOCIATED ANTIGEN APPROACH

NCT02494167

Recruiting

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

This research study uses Marker’s MultiTAA therapy to treat patients with acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS). Investigators will grow T cells from patients’ stem cell donors in the laboratory train them to recognize the tumor proteins WT1, NY-ESO-1, PRAME, and Survivin, which are expressed on most AML and MDS cancer cells.

This Phase 1 study will investigate the safety of increasing dose levels of MultiTAA T cells trained against all four tumor-associated proteins, from 5 x 106 cells up to 2 x 107 cells, in patients with AML or MDS 30 days post hematopoietic stem cell transplant. Patients will be monitored for dose-limiting toxicities and for anti-tumor effects for four weeks, and for expansion and persistence of the MultiTAA T cells for one year.

NCT01333046

Recruiting

Administration of TAA-Specific CTLs; Hodgkin or Non-Hodgkin Lymphoma; TACTAL (TACTAL)

This research study uses Marker’s MultiTAA therapy to treat patients with Hodgkin or non-Hodgkin lymphomas. Investigators will grow T cells from the patient in the laboratory to train them to recognize five tumor associated proteins that commonly show on lymphoma cells: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX.

This Phase 1 trial will investigate three aspects of the MultiTAA therapy. The first phase will “antigen-escalate,” evaluating the safety of training patients against an increasing number of tumor-associated proteins. The second phase will “dose-escalate,” evaluating the safety of increasing dose levels of MultiTAA T cells trained against all five tumor-associated proteins, from 5 x 106 cells up to 2 x 107 cells. The third stage will evaluate if treatment with azacytidine before the MultiTAA therapy will enhance the treatment. Patients will be monitored for eight weeks for adverse events related to the therapy, for one year for expansion, persistence, and anti-tumor effects of the Multi-TAA therapy, and for one year for evidence of an epitope spreading, or an increase in the spectrum of tumor associated antigens targeted by a patient’s own T cells.

NCT02291848

Recruiting

Tumor-Associated Antigen-Specific Cytotoxic T-Lymphocytes for Multiple Myeloma (TACTAM)

This research study uses Marker’s MultiTAA therapy to treat patients with multiple myeloma. Investigators will grow T cells from the patient in the laboratory to train them to recognize five tumor associated proteins that commonly show on lymphoma cells: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX.

This Phase 1 study is designed to evaluate the safety and efficacy of the MultiTAA therapy in patients with multiple myeloma. Patients will be evaluated over the course of one year to evaluate the expansion, persistence and anti-tumor effects.

NCT03093350

Recruiting

TAA Specific Cytotoxic T Lymphocytes in Patients With Breast Cancer (TACTIC)
This research study uses Marker’s MultiTAA therapy to treat patients with refractory breast cancer. Investigators will grow T cells from the patient in the laboratory to train them to recognize four tumor associated proteins which commonly show on breast cancer: NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2.

This Phase 2 study is designed to determine the clinical efficacy and side effects of the MultiTAA therapy in patients with breast cancer. Patients will be monitored over the course of twelve weeks for a clinical response according to the RECIST criteria.

NCT03192462

Recruiting

TAA Specific Cytotoxic T Lymphocytes in Patients With Pancreatic Cancer (TACTOPS)

Patients who have pancreatic cancer that has come back or has not gone away after treatment, including the standard treatment for this disease or patients who are not eligible for or have elected not to receive standard of care chemotherapy, and patients who will have surgery after treatment for pancreatic cancer are eligible for this study. This is a research study using special immune system cells called tumor-associated antigen (TAA)-specific cytotoxic T lymphocytes, a new experimental therapy.

The proteins that are targeted in this study are called tumor-associated antigens (TAAs). These are cell proteins that are specific to the cancer cell. They do not show, or they show up in low quantities, on normal human cells. In this study, five common TAAs will be targeted. They are called NY-ESO-1, MAGEA4, PRAME, Survivin and SSX2. On a different study, patients have been treated and so far this treatment has shown to be safe.

Investigators now want to try this treatment in patients with pancreatic cancer.

These TAA-specific cytotoxic T lymphocytes (TAA-CTLs) are an investigational product not approved by the Food and Drug Administration.

NCT02475707

Recruiting

Administration of Donor MultiTAA-Specific T Cells for ALL (STELLA)

This research study uses Marker’s MultiTAA therapy to treat patients with acute lymphoblastic leukemia (ALL) after an allogeneic hematopoietic stem cell transplant (HSCT). Investigators will grow T cells from patients’ stem cell donors in the laboratory to train them to recognize three tumor associated proteins which commonly show on ALL: WT1, PRAME and Survivin

This Phase I study will investigate the safety of increasing dose levels of MultiTAA T cells trained against all three tumor-associated proteins, from 5 x 106 cells up to 2 x 107 cells, in patients with ALL 30 days post hematopoietic stem cell transplant. Patients will be monitored for dose-limiting toxicities and for anti-tumor effects for four weeks, and for expansion and persistence of the MultiTAA T cells for one year.

Marker is planning to initiate multiple Phase 2 clinical trials in relapsed/refractory acute myelogenous leukemia, non-Hodgkin’s lymphoma and multiple myeloma in 2019.