Center for Immunology and Immune Therapies

Below are current clinical trials.

Filter this list of studies by location, status and more.

1. A Study of R-ICE and Lenalidomide for Treating Patients with First-Relapse/Primary Refractory Diffuse Large B-Cell Lymphoma

   Rochester, Minn., Jacksonville, Fla.

   The purpose of this study is to assess the side effects and best dose of lenalidomide when given together with rituximab-ifosfamide-carboplatin-etoposide (R-ICE) and how well they work in treating patients with diffuse large B-cell lymphoma that has returned after a period of improvement and that has not responded to previous treatment. Biological therapies, such as lenalidomide, may stimulate or suppress the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as R-ICE, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving lenalidomide with R-ICE may be a better treatment for patients with diffuse large B-cell lymphoma.

2. Dendritic Cell Therapy After Cryosurgery in Combination With Pembrolizumab in Treating Patients With Stage III-IV Melanoma That Cannot Be Remove by Surgery

   Rochester, Minn.

   This phase Ib/II trial studies how well dendritic cell therapy after cryosurgery in combination with pembrolizumab works in treating patients with stage III-IV melanoma that cannot be removed by surgery. Vaccines made from a person's white blood cells mixed with tumor proteins may help the body build an effective immune response to kill tumor cells. Cryosurgery, also known as cryoablation or cryotherapy, kills tumor cells by freezing them. Monoclonal antibodies, such as pembrolizumab, may block tumor growth in different ways by targeting certain cells. Giving dendritic cell therapy after cryosurgery in combination with pembrolizumab may work better in treating patients with melanoma.

3. Study of Imprime PGG and Pembrolizumab in Advanced Melanoma and Triple Negative Breast Cancer

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   Objective: To determine the Overall Response Rate (ORR) to Imprime PGG + pembrolizumab in subjects with advanced melanoma or metastatic TNBC

   Safety: To characterize the safety of Imprime PGG + pembrolizumab given in combination

   Hypothesis: Restore (for melanoma) or enhance (for TNBC) sensitivity to checkpoint inhibitors (CPI) by appropriate and effective stimulation of the subject's innate and adaptive immune systems in those subjects who have failed 1st line therapy

   The study will incorporate Simon's optimal 2-stage design with sample size fixed at 12 subjects each in Stage 1 for advanced melanoma and for Triple Negative Breast Cancer (TNBC) subjects. The safety criterion of ≤ 4 (or ≤ 33%) subjects with Grade 3/4 adverse events in Cycle 1 within either tumor type must be met in order to proceed to Stage 2. The starting dose is 4 mg/kg for Imprime PGG. In the event there are a total of > 4 (or > 33%) of subjects with Grade 3/4 adverse events in Cycle 1, the dose of Imprime PGG will be reduced to 2 mg/kg, and Stage 1 will be repeated at a dose of 2 mg/kg with an additional cohort of n=12 subjects. For the dose that meets the safety criterion in Stage 1, at least 1 response in melanoma subjects and 2 responses in TNBC subjects amongst the 12 subjects within each tumor type must be observed in order to proceed to Stage 2.

   Stage 2 will enroll an additional 17 subjects with melanoma, and 30 subjects with TNBC. For the dose that meets the Stage 1 safety criterion, success will be declared if at least 4 amongst the total of up to 29 subjects with melanoma, and 13 amongst the total of up to 42 subjects with TNBC achieve an objective response.

4. Cyclophosphamide and Vaccine Therapy in Treating Patients with Stage II-III Breast, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer

   Rochester, Minn.

   This study is being done to gather information. The study will provide important information related to the safety and the effect of the vaccine on a patient's immune system. What researchers learn from this study could possibly be used in the future to prevent or delay recurrence of breast or ovarian cancers.

5. SMAC Mimetic LCL161 Alone or With Cyclophosphamide in Treating Patients With Relapsed or Refractory Multiple Myeloma

   Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

   This phase II trial studies how well second mitochondrial-derived activator of caspases (SMAC) mimetic LCL161 alone or with cyclophosphamide works in treating patients with relapsed or refractory multiple myeloma. Biological therapies, such as SMAC mimetic LCL161, may stimulate the immune system in different ways and stop cancer cells from growing. Drugs used in chemotherapy, such as cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving SMAC mimetic LCL161 alone or with cyclophosphamide is more effective in treating multiple myeloma.

6. Collection of Tissue and Blood in Patients with Allergic and Immunologic Disorders

   Scottsdale/Phoenix, Ariz.

   Allergic and immunologic disorders are very common but some are very poorly understood. Numerous studies of the epidemiology, characteristics, diagnosis and treatment of these disorders are urgently needed to identify and optimally treat affected patients. Though numerous challenges impact the progress of research in this area, specimens are needed to test new hypotheses and methodologies.  We aim to create a registry and biorepository of tissue and fluid specimens for future studies.

7. A Study of Patients Treated for Chronic Granulomatous Disease Since 1995

   Rochester, Minn.

   Chronic granulomatous disease (CGD) is an inherited immune system abnormality in which bone marrow transplantation has been shown to be curative. However the risks of transplantation are high and not all patients with CGD may need to undergo this high risk procedure. The purpose of this study is to determine the long term medical condition and daily functioning of patients with CGD after a transplant and if possible, compare these results to patients who do not undergo a transplant.

8. Spatial and Molecular Architecture of Tumor Environments Responsive to IO (immuno-oncology) Therapy

   Rochester, Minn.

   The purpose of this study is to gain stepwise understanding of the fundamental biology governing human antitumor immunity, by systematic study of the tumor-immune interface at the level of the TME, taking advantage of the heterogeneity of different interacting tumor and immune cell subsets.

9. Risk Prediction for Immune Checkpoint Inhibitor Associated Diabetes Mellitus

   Rochester, Minn.

   The purpose of this study is to identify risk factors for ICI associated diabetes mellitus and to assess the severity and natural course of this immune related adverse effect.

10. A Study to Better Understand How to Predict and Manage Patients Who are at High Risk for Developing Rheumatic Immune-related Adverse Events While Receiving Treatment for Melanoma

    Rochester, Minn.

    The purpose of this study is to:

    1. Understanding how to better predict and manage patients at high risk for rheumatic irAEs and tailor therapy without diminishing cancer treatment efficacy and,
    2. Further inform our understanding on the pathogenesis of classic rheumatologic diseases.
    3. Establish a repository of biological samples from patients with irAE and corresponding rheumatologic