Gene-Modified Immune Cells (FH-MCVA2TCR) in Treating Patients With Metastatic or Unresectable Merkel Cell Cancer

ATTAC-MCC: Phase I/II study of Autologous CD8+ and CD4+ Transgenic T cells expressing high affinity MCPyV-specific TCRs combined with Avelumab and Class I MHC -upregulation in patients with metastatic MCC refractory to PD-1 axis blockade

This phase I/II trial studies the side effects of gene-modified immune cells (FH-MCVA2TCR) and to see how well they work in treating patients with Merkel cell cancer that has spread to other parts of the body (metastatic) or that cannot be removed by surgery (unresectable). Placing a gene that has been created in the laboratory into immune cells may improve the body's ability to fight Merkel cell cancer.

ATTAMAGE-A1.1: Phase I/II study of Autologous CD8+ and CD4+ Transgenic T cells expressing high affinity MAGE-A1-specific T-Cell Receptor (TCR) combined with Atezolizumab in patients with metastatic MAGE-A1 expressing cancer.

Metastatic triple negative breast cancer (TNBC), urothelial, and non-small cell lung cancer (NSCLC) are solid tumor malignancies with abysmal survival rates following progression on initial therapies. There are currently few consistently effective treatments for individuals with these cancers following treatment with PD-L1 axis blockade. We have developed an engineered autologous T cell therapy targeting cancer testes antigen MAGE-A1.  In a phase I trial, we seek to determine the safety and potential efficacy of this T cell therapy in addition to an FDA approved therapeutic standard anti-PD-L1 therapeutic, atezolizumab, for patients with advanced triple negative breast cancer, urothelial, or non-small cell lung cancers whose tumors express high level of MAGE-A1 and have become resistant to PD-L1 axis treatments.

WT1 (126) Liquid : Phase I/II study of Autologous CD4+ and  CD8+ T cells that have been transduced to express a WT1-specific T Cell receptor for treatment of AML

AML patients at high risk of  relapse without hematopoietic stem cell transplantation (HCT), as defined by any of: (a) presence of measurable residual disease (MRD) detected by flow cytometry, cytogenetics, or “next-generation sequencing”/PCR at time of complete remission; (b)  failure of neutrophil count to reach 1,000 and platelet count  100,000 post-treatment (i.e. CRp, CRi, CRh, or morphologic leukemia-free state [MLFS]);  (c) pre-treatment ELN 2017 risk categories “intermediate” or “adverse”;  or (d) more than 1 course of induction therapy required to attain remission.

The safety and feasibility of administering autologous engineered WT1-specific T cells as post-remission AML therapy will be assessed in this study. For the first, second and third cohorts, patients will receive 1 x 10⁹, 1 x 10¹⁰ and 1 x 10¹⁰ T_TCR-DL10 preceded by cyclophosphamide and fludarabine (Cy/Flu) conditioning respectively, after count recovery from their last cycle of consolidation. All patients will have the option of receiving a second infusion (if available) based on the results of a marrow performed 4 weeks later or at any time within 1 year of the first.

Phase I/II study of Autologous CD8+ Transgenic T cells expressing high affinity mesothelin-specific T-Cell Receptor (TCR) for patients with unresectable/metastatic pancreatic cancer

Metastatic pancreatic cancer patients have a mean survival of 6 months following progression on initial first line chemotherapy. There are currently few treatment options and include strategies such as second-line chemotherapy with response rates averaging 10%, median PFS of 3 months and OS of 6 months. We have developed an engineered autologous T cell therapy targeting mesothelin, an antigen overexpressed by pancreatic cancer cells.  In a phase I trial, we seek to determine the safety and preliminary antitumor efficacy of this T cell therapy in patients with metastatic pancreatic ductal adenocarcinomas whose tumors express mesothelin and have progressed on prior chemotherapy.