allogeneic K562-GM tumor cell vaccine / National Cancer Institute - LARVOL DELTA

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Dana-Farber Cancer Institute | Active, not recruiting ➔ Completed | N=40 ➔ 24

Enrollment change • Trial completion • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CSF2

A phase I trial of vaccination with lethally irradiated lymphoma cells admixed with granulocyte-macrophage colony-stimulating factor secreting K562 cells for the treatment of follicular lymphoma. (PubMed, Leuk Lymphoma) - P1 | "Vaccines contained dose levels of 5 × 106 or 1 × 107 GM-K562 cells admixed with autologous tumor cells at doses ranging from 1 × 105 to 5 × 107.Correlative studies did not demonstrate a significant immune response as assessed by delayed-type hypersensitivity reactions, B and T cell subsets, and natural killer cell subsets. Future vaccine studies should focus on identifying lymphoma-specific immunogenic proteins and modifying the vaccine immune adjuvant."

Journal • P1 data • Follicular Lymphoma • Hematological Malignancies • Immunology • Lymphoma • Oncology

Efficient ex vivo expansion of conserved element vaccine-specific CD8+ T-cells from SHIV-infected, ART-suppressed nonhuman primates. (PubMed, Front Immunol) - "NHP CE-XTCs expanded up to 10-fold following co-culture with the combination of primary dendritic cells (DCs), PHA blasts pulsed with CE peptides, irradiated GM-K562 feeder cells, and autologous T cells from CE-vaccinated NHP...However, consistent with prior studies with human HXTC and these cells' predominant CD8 effector phenotype, we did not observe significant differences in CE-XTC persistence or SHIV acquisition in two CE-XTC-infused NHP compared to two control NHP. These data support the safety and feasibility of our approach and underscore the need for continued development of CE-XTC and similar cell-based strategies to redirect and increase the potency of cellular virus-specific adaptive immune responses."

Journal • Preclinical • Human Immunodeficiency Virus • Infectious Disease • CD8

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma (clinicaltrials.gov) - P1 | N=40 | Active, not recruiting | Sponsor: Dana-Farber Cancer Institute | Trial primary completion date: Aug 2021 ➔ Aug 2023

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology • CSF2

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial primary completion date: Aug 2020 ➔ Aug 2021

Trial primary completion date • Follicular Lymphoma • Hematological Malignancies • Lymphoma • Oncology

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia (clinicaltrials.gov) - P1; N=3; Completed; Sponsor: Dana-Farber Cancer Institute; Active, not recruiting ➔ Completed; N=30 ➔ 3; Trial completion date: Jan 2022 ➔ Sep 2020

Clinical • Enrollment change • Trial completion • Trial completion date • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • PCR

Reduced Intensity Stem Cell Transplantation for Chronic Lymphocytic Leukemia Followed by Vaccination (clinicaltrials.gov) - P1; N=27; Completed; Sponsor: Dana-Farber Cancer Institute; Active, not recruiting ➔ Completed; N=40 ➔ 27; Trial completion date: Jul 2021 ➔ Apr 2020

Enrollment change • Trial completion • Trial completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Oncology • Transplantation

Vaccination With GM-K562 Cells in Patients With Advanced Myelodysplastic Syndrome (MDS) or Acute Myeloid Leukemia (AML) After Allogeneic Hematopoetic Stem Cell Transplantation (clinicaltrials.gov) - P1; N=33; Completed; Sponsor: Dana-Farber Cancer Institute; Active, not recruiting ➔ Completed; Trial completion date: Dec 2026 ➔ Jan 2020

Clinical • Trial completion • Trial completion date • Acute Myelogenous Leukemia • Anemia • Chronic Myeloid Leukemia • Chronic Myelomonocytic Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • Myelodysplastic Syndrome • Oncology • Transplantation • HLA-DRB1

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial completion date: Jan 2020 ➔ Jan 2022

Clinical • Trial completion date • PCR

Tumor Cell Vaccine for Patients Undergoing Surgery for Sarcomas, Melanomas, Germ Cell Tumors, or Malignancies That Have Metastasized to the Lungs, Pleura, or Mediastinum (clinicaltrials.gov) - P1; N=19; Terminated; Sponsor: National Cancer Institute (NCI); Trial completion date: Jun 2014 ➔ Feb 2020; Completed ➔ Terminated; Trial primary completion date: Jun 2014 ➔ Feb 2020; Per stopping rule if 12 patients underwent immune response analysis after 6 vaccinations and none developed a response, the protocol would stop accrual.

Clinical • Trial completion date • Trial primary completion date • Trial termination

Pilot Study of Allogeneic Tumor Cell Vaccine With Metronomic Oral Cyclophosphamide and Celecoxib in Patients Undergoing Resection of Lung and Esophageal Cancers, Thymic Neoplasms, and Malignant Pleural Mesotheliomas (clinicaltrials.gov) - P1; N=10; Terminated; Sponsor: National Cancer Institute (NCI); Trial completion date: Mar 2015 ➔ Feb 2020; Completed ➔ Terminated; Closed accrual due to unpromising results and the opening of study 14C0053 targeting the same population.

Clinical • Trial completion date • Trial termination • IL2RA

Vaccination for the Treatment of Previously Untreated or Relapsed Follicular Lymphoma (clinicaltrials.gov) - P1; N=40; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial primary completion date: Aug 2019 ➔ Aug 2020

Trial primary completion date • CSF2

Vaccination With Lethally Irradiated Glioma Cells Mixed With GM-K562 Cells in Patients Undergoing Craniotomy For Recurrent Tumor (clinicaltrials.gov) - P1; N=11; Completed; Sponsor: Massachusetts General Hospital; Recruiting ➔ Completed; N=25 ➔ 11; Trial primary completion date: Jun 2011 ➔ Aug 2009

Clinical • Enrollment change • Trial completion • Trial primary completion date

Vaccine Therapy and Imatinib Mesylate in Treating Patients With Chronic Phase Chronic Myelogenous Leukemia (clinicaltrials.gov) - P1; N=30; Active, not recruiting; Sponsor: Dana-Farber Cancer Institute; Trial completion date: Jan 2019 ➔ Jan 2020

Clinical • Trial completion date