Clinical Study to Evaluate the Safety and Feasibility of spCART-269 Injection in the Treatment of...
Multiple MyelomaThe trial is a single arm, single-center, non-randomized phase I clinical trial which is designed to evaluate the safety and efficacy of spCART-269 in treatment of relapsed or refractory multiple myeloma patients.
Clinical Study to Evaluate the Safety and Efficacy of IM21 CAR-T Cells in the Treatment of Elderly...
Multiple MyelomaThis is a single center study to assess the efficacy and safety of IM21 CAR-T cells in adult with R/R multiple myeloma in China.
Study of Carfilzomib in Multiple Myeloma Relapsed After High-dose Melphalan With Autologous Stem...
Multiple MyelomaThis study evaluates induction therapy with carfilzomib-cyclophosphamide-dexamethasone before salvage high-dose melphalan with autologous stem cell support (HDT) in multiple myeloma patients with relapse after HDT done at diagnosis. In addition, the study evaluates the effect of maintenance therapy after salvage HDT in multiple myeloma. After salvage HDT half of the patients receive maintenance therapy with carfilzomib/dexamethasone while the other half are observed without maintenance therapy.
Clinical Study of CAR-BCMA T Cells in Patients With Refractory or Relapsed Multiple Myeloma
Refractory or Relapsed Multiple MyelomaA single arm, open-label pilot study is designed to determine the safety, efficacy and cytokinetics of CAR-BCMA T cells in patients with BCMA-positive refractory or relapsed multiple myeloma.
A Study of Dabrafenib and/or Trametinib in Patients With Relapsed and/or Refractory Multiple Myeloma...
Multiple MyelomaThis research study is studying a targeted therapy as a possible treatment for multiple myeloma. The names of the study drugs involved in this study are: Trametinib Dabrafenib
Carfilzomib Thalidomide and Dexamethasone in Patients With Relapsed and/or Refractory Multiple Myeloma...
Relapsed and/or Refractory Multiple MyelomaAll patients with multiple myeloma (MM) are destined to relapse even with the best available approved agents. Median OS from diagnosis in the current era is reported at 5.4 years. Given that myeloma remains an incurable disease, future improved OS is therefore reliant on the expansion of salvage options for patients with RRMM. Carfilzomib (formerly PR-171) is a tetrapeptide epoxyketone-based irreversible inhibitor of the 20S proteasome. This second-generation proteasome inhibitor (PI) is structurally and mechanistically different to the dipeptide boronic acid PI, bortezomib. Compared to bortezomib, carfilzomib showed less off-target activity that may account for the reduced myelosuppression and reduced neuropathy that is observed compared to bortezomib. As monotherapy, carfilzomib has demonstrated robust and durable activity in heavily pre-treated patients with RRMM in phase I and II trials The idea of combining a PI and an immunomodulatory drug (IMiD) such as thalidomide or lenalidomide is attractive in MM due to the efficacy previously demonstrated with combination bortezomib, thalidomide and dexamethasone. Such efficacy obviates the need for chemotherapy that is known to induce genetic instability and in turn gives rise to secondary cancers. In combination with lenalidomide (25mg), Niesvizky and colleagues have demonstrated a maximum planned dose (MPD) of carfilzomib as 20/27 mg/m2 with promising safety and efficacy. Combination carfilzomib and thalidomide, as opposed to lenalidomide, is practically a more affordable regimen that will be more applicable to the Asia-Pacific region.
CKD-581 + Bortezomib + Dexamethasone in Patients With Previously Treated Multiple Myeloma
MyelomaMultipleThis study is to determine the maximum tolerated dose(MTD), dose limiting toxicity(DLT), safety and pharmacokinetics(PK) profile of a single agent CKD-581 injection in Combination with Bortezomib and Dexamethasone in patients with Previously Treated Multiple Myeloma.
Multi-CAR T Cell Therapy in the Treatment of Multiple Myeloma
Multiple MyelomaThe aim of this clinical trial is to assess the feasibility, safety and efficacy of autologous CAR T cell immunotherapy targeting multiple cancer cell surface antigens in relapsed and refractory multiple myeloma patients. Another goal of the study is to learn more about the persistence and function of CAR T cells in the body.
Maintenance Treatment of Multiple Myeloma (MM) After Autologous Peripheral Blood Transplant (PBSCT)...
Multiple MielomaMultiple myeloma accounts for approximately 1% of all cancers and 10% of hematologic malignancies. Between 50 and 70% of symptomatic patients presented response to induction chemotherapy. The rate of complete responses (CR) achieved with standard induction of these treatments is less than 5% of cases and the median event-free survival between 2 and 3 years although most of the patients died from the disease. High dose chemotherapy with autologous stem cell transplant has improved the response rate and survival of patient with MM. However eventually all patients relapse with a median EFS between 40-50 months post-transplant. To improve these results and sustain remission, various maintenance treatment have been proposed as is the case of Interpheron alpha2b s.c. (Intron A) that has shown benefits in a meta-analysis. Intron A s.c. need administration of 3 days per week and is not well tolerated Recently a new formulation of Interpheron alpha2b is available. Conjugated with polietilenglicol (Pegintron) that need only one dose weekly and has not been tested in MM. The purpose of this study is to evaluate the role of Pegintron as maintenance after autologous transplant in MM
Safety Study of Anti LewisY Chimeric Antigen Receptor in Myeloma, Acute Myeloid Leukemia or Myelodysplastic...
Multiple MyelomaAcute Myeloid Leukaemia1 morePatients with some forms of acute myeloid leukemia (AML) and multiple myeloma (MM) are not cured with conventional therapy and new approaches are needed. For the last 15 years we have investigated the potential of using a patient's own T cells (a type of white blood cell [WBC]) to eradicate the tumor. We have demonstrated the feasibility of this approach in cell culture and animal models of AML and MM. Over the last 5 years we have been preparing to treat patients as part of a Phase I (first in human) clinical trial. The trial treatment involves collecting the patient's own WBCs from the blood by a standard well established and safe process called apheresis. The cells are then cultured in a specialized laboratory (under Good Manufacturing Practice conditions, similar to standards under which pharmaceuticals are produced) over 12 days to convert the cells to specialized tumor-attacking T cells. Early in that culture process the cells are exposed to a virus (that is modified so that it cannot infect or replicate outside the special culture conditions) that contains a special gene. Via the virus, this gene inserts into the patient's T cells in culture and gets incorporated into the T cell's genetic machinery. As the T cells replicate, the new gene produces a protein receptor that becomes part of the patient's T cells. This protein receptor on the T cells has the capacity to specifically recognize and bind to a protein on the leukemia or myeloma cells called the "Lewis Y" antigen. After the modified T cells are infused into the patient, they home into the bone marrow (this tracking is monitored by special radiological techniques) where the new protein receptor on the T cell surface can recognize and bind to the cancer cells (which express Lewis Y). Once bound onto the cancer cells, the T cells get activated and subsequently replicate and kill the cancer cells. The novelty of this approach is that the T-cells will only kill cells that have the Lewis Y on their surface - the cancer cells. Moreover, because there are few normal cells in a person's body that carry Lewis Y, this treatment is likely to only have minor side effects. This gene therapy trial is unique and although the primary purpose is to test the safety of this approach, patients will be monitored closely for anti-tumor responses. As the trial progresses, the dose of T cells infused will increase, in the hope that this will result in a better and stronger immune response to the leukemia or myeloma.