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NIH grant 1R01FD008756-01: Safety and Efficacy of a Multi-Tumor-Associated Antigen-Specific T Cell Therapy in Pancreatic Cancer Patients
Institute: {'code': 'FD', 'abbreviation': 'FDA', 'name': 'Food and Drug Administration', 'admin_org_id': '12500799', 'admin_funding_url': ''}. PI: Juan Fernando Vera. Award: $645493.
Start: 2026-09-25T00:00:00.
ABSTRACT
Pancreatic cancer (PC) is an orphan disease affecting approximately 67,440 people annually in the US. With a
5-year relative survival of only 13% for all stages combined and 3.2% for metastatic disease, PC represents one
of the most aggressive malignancies. Although surgical resection provides the best curative option, <20% of PC
patients are eligible for surgery at diagnosis. Patients with locally advanced unresectable PC typically have a
median survival of less than 1 year. Standard frontline treatment includes FOLFIRINOX (FFX) or NALIRIFOX
(NLX), yet these result in median overall survival of only 11.1 months and are associated with cumulative
toxicities that limit longer treatment. Patients with locally advanced unresectable PC have an urgent unmet need
for treatments that extend median survival beyond 12 months.
Marker Therapeutics has developed MT-601, a multi-tumor associated antigen (mTAA)-specific autologous T
cell product that recognizes six target antigens expressed by pancreatic tumors: PRAME, NY-ESO-1, survivin,
MAGE-A4, SSX2, and WT1. This non-engineered T cell therapy limits tumor adaptation through negative antigen
selection (immune escape) while reducing on-target, off-tumor effects. MT-601 is manufactured from patient
apheresis material using a simplified process that stimulates and expands polyclonal tumor-specific T cells. The
product consists of CD4+ and CD8+ T cells that recognize target cells via native T cell receptors, interacting with
both class I and II MHC complexes. Preliminary data from the Phase 1 TACTOPS trial of mTAA-specific T cells
in pancreatic cancer demonstrated clinical benefit with 1 complete response, 2 partial responses, and 8 stable
disease among 13 FFX treated patients. To date, mTAA-specific T cells have shown an excellent safety profile
in >200 patients across 7 cancer indications, without cytokine release syndrome, neurotoxicity, or dose-limiting
toxicities. MT-601 represents an improved product with the addition of WT1, higher dosing (400×10⁶ cells vs
20×10⁶), and enhanced manufacturing yielding 4X increased potency.
Therefore, Marker proposes a Phase 1, single-center, open-label clinical trial (PANACEA, NCT# 06549751) to
evaluate the safety and efficacy of MT-601 administered during maintenance capecitabine following FFX or NLX
in patients with locally advanced unresectable PC. The trial includes Dose Escalation using a modified 3+3
design followed by Expansion at the recommend dose. Specific Aim 1 will assess safety and efficacy of MT-601
in combination with maintenance capecitabine, determining the maximum tolerated dose and evaluating
progression-free survival and duration of response. Specific Aim 2 will correlate biological characteristics of MT-
601 with clinical outcomes, including T cell expansion, persistence, clonality, and anti-tumor immune effects.
Successful completion of this trial will provide critical dosing, safety, and efficacy data necessary to advance MT-
601 to a randomized pivotal study comparing MT-601 plus maintenance chemotherapy versus maintenance
chemotherapy alone, ultimately advancing this therapy toward market approval for PC patients.document fetched 2026-10-04 02:43