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Clinical Studies


  • 68284528MMY2003, A Phase 2, Multicohort Open-Label Study of JNJ-68284528, a Chimeric Antigen Receptor T Cell (CAR-T) Therapy Directed Against BCMA in Subjects With Multiple Myeloma (CARTITUDE-2) Rochester, Minn.

    The purpose of this study is to evaluate the overall minimal residual disease (MRD) negative rate of participants who receive JNJ-68284528.

  • A blood collection protocol for patients with neoplasms expressing highly prevalent cancer-associated antigens in order to provide peripheral blood mononuclear cells (PBMC) for preclinical in vitro immunologic investigations Scottsdale/Phoenix, Ariz., Rochester, Minn.

    This is a peripheral blood Collection Protocol to study the T-cell immune responses of patients with malignancies displaying one of three different patterns of antigen expression: (1) Cohort 1 focuses on cancers displaying a high (80-90%) frequency of MUC1 expression and variably high (unreported to 50%) HER2/neu (“HER2”) expression; (2) Cohort 2 focuses on primary or secondary myelofibrosis (MF) displaying mutated calreticulin (muCALR); (3) Cohort 3 focuses on glioblastoma multiforme (GBM) which often displays the cytomegalovirus tegument protein CMVpp65. Cohort 1 includes blood collections for in vitro studies which are a component of NIH-funded Project 3 within the Mayo Clinic Pancreatic SPORE, “Optimal Immunotargeting of MUC1 for Advanced Pancreatic Cancer” (Principal Investigator Dr. Gendler). Eligibility Criteria, keep current Eligibility Criteria, but precede by:: "Three cohorts of patients will be collected.:Cohort 1 includes (1) advanced unresectable pancreatic cancer, (2-4) advanced, unresectable breast cancer (up to 6 donors per phenotype: triple negative [HER2, estrogen and progesterone receptor (ER and PR) all negative], HER2 positive whatever the ER/PR status,, and HER2 negative/ER positive), (5) advanced, unresectable colorectal cancer, (6) advanced, unresectable ovarian cancer, (7) advanced, unresectable clear cell kidney cancer, (8) advanced, unresectable bladder cancer, (9) advanced, unresectable lung adenocarcinoma, (10) advanced, unresectable multiple myeloma. Also eligible are (11) up to 6 donors with triple negative breast cancer and (12) up to 6 donors with colorectal cancer who have no clinical evidence of residual (macroscopic) disease following an attempt to perform definitive treatment (including surgery, radiation and/or adjuvant or neoadjuvant chemotherapy). Cohort 2 includes (1) muCALR+ primary MF, and (2) muCALR+ secondary MF. Cohort 3 includes (1) CMVpp65 absent and (2) CMVpp65 present GBM.. Patients in all subcohorts except 1.11 and 1.12 currently have unresectable advanced or recurrent cancers, and may undergo the collection: (1) prior to initiation of systemic therapy; (2) if patient is already engaged in an ongoing cyclical systemic therapy, collection should be within three days prior to the end of the current therapy cycle, if necessary delayed until all clinical parameters are acceptable to proceed with the next planned cycle of therapy; (3) if patient is completing non-cyclical therapy, collection should be at least 2.5-3.0 weeks after completion of the therapy, or delayed until all clinical parameters are acceptable to proceed with any planned follow-up therapy. Patients in cohorts 1.11 and 1.12 (currently lacking detectable cancer) will undergo the collection at least 4 weeks after conclusion of therapy. In addition to belonging to one of these 16 subcohorts, patients will be required to have bloodwork demonstrating a blood hemoglobin ≥ 10 g/dL, a neutrophil count ≥ 1,500 /microliter, and platelets ≥ 100,000 /microliter, performed within 7 days prior to the collection.

  • BB2121-EAP-001, Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Nonconforming for Commercial Release (BB2121-EAP-001) Rochester, Minn., Jacksonville, Fla.

    The purpose of this study is to evaluate the safety and effectiveness of nonconforming idecabtagene vicleucel (ide-cel) in subjects with multiple myeloma per the approved prescribing information. 

  • Cell, Serum, and Bone Marrow Bank for Patients receiving Chimeric Antigen Receptor T Cell Therapy for the Treatment of Cancer Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

    The purpose of this study is to store blood, serum and bone marrow so that they can be used for laboratory studies that may contribute to finding the exact function of the CART cells and the factors that may determine disease progression and treatment response.

  • GC-LTFU-001 - Long-Term Follow-up Protocol for Subjects Treated With Gene-Modified T Cells Rochester, Minn., Scottsdale/Phoenix, Ariz., Jacksonville, Fla.

    This is a prospective study for the long-term follow-up (LTFU) of safety and efficacy for all pediatric and adult subjects exposed to Gene-modified (GM) T cell therapy participating in a previous Celgene sponsored or Celgene alliance partner sponsored study. Subjects who received at least one GM T cell infusion, will be asked to roll-over to this LTFU protocol upon either premature discontinuation from, or completion of the prior parent treatment protocol.

  • Immune Monitoring and Immunotherapy in Myeloma Rochester, Minn.

    Characterize and identify the immune phenotype of patients with multiple myeloma by flow cytometry of peripheral blood circulating and bone marrow immune cells and by testing the immunogenticity of these cells in vitro. Samples will be collected from patients longitudinally at baseline and post treatments to examine the effect of treatments on host immunity. The treatments include IMiDs, proteosome inhibitors, chemotherapy, monoclonal antibodies and stem cell transplantation.To c

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