Myeloma Clinical Trial
Official title:
Phase I/II Trial of Cord Blood-Derived NK Cells Genetically Engineered With NY-ESO-1 TCR/IL-15 Cell Receptor for Relapsed/Refractory Multiple Myeloma
To find the recommended dose of NY-ESO-1 TCR/IL-15 NK cells that can be given to patients with relapsed or refractory MM. To learn if the dose of NY-ESO-1 TCR/IL-15 NK cells found in Part A can help to control the disease.
Primary Objectives: - Part A: To assess dose-limiting toxicity (DLT) and determine the safety and optimal cell dose of NY-ESO-1 TCR/IL-15 NK cells in patients with relapsed/refractory multiple myeloma. - Part B: To assess the day +90 overall response rate in patients treated at the optimal cell dose. Secondary Objectives: - Assess day +180 progression-free survival (PFS). - Quantify the persistence of infused allogeneic donor TCR-transduced CB-derived NK cells in the recipient. - To conduct comprehensive immune reconstitution studies. - To obtain preliminary data on quality of life and patient experience. - Assess duration of response (DOR) Secondary end points - Day +180 PFS rate; - NY-ESO-1 TCR/IL-15 NK cell numbers in peripheral blood vs time profile; - Characterization of lymphocyte populations at various time points; - PROMIS-29 quality of life questionnaire score. - Duration of response ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT03832127 -
Evaluation of PET 18F-Fludarabine for the Initial Assessment and End-treatment of Symptomatic Multiple Myeloma Patients
|
Phase 1 | |
| Completed |
NCT01413178 -
A Randomized Trial to Compare Busulfan + Melphalan 140 mg/m2 With Melphalan 200 mg/m2 as Preparative Regimen for Autologous Hematopoietic Stem Cell Transplantation for Multiple Myeloma
|
Phase 3 | |
| Recruiting |
NCT03641456 -
VRD as Induction Followed by VR Maintenance in Patients With Newly Diagnosed High Risk Multiple Myeloma
|
Phase 2 | |
| Terminated |
NCT02907073 -
Positron Emission Tomography (PET) Imaging Studies With NIS Reporter
|
Phase 1/Phase 2 | |
| Completed |
NCT03135925 -
Feasibility of Pre Transplant Exercise (Pre-habilitation) for Multiple Myeloma Patients Awaiting Autologous Stem Cell Transplantation
|
N/A | |
| Withdrawn |
NCT02114502 -
Carfilzomib/SAHA Combined With High-Dose Gemcitabine/Busulfan/Melphalan With Autologous Stem Cell Transplant in Myeloma
|
Phase 2 | |
| Completed |
NCT01700608 -
Prospective Observational Study on Plerixafor After Chemotherapy
|
N/A | |
| Completed |
NCT00800839 -
Busulfan and Fludarabine Followed by Post-transplant Cyclophosphamide
|
Phase 2 | |
| Completed |
NCT00794261 -
Stem Cell Mobilization With Pegfilgrastim in Lymphoma and Myeloma
|
Phase 2 | |
| Completed |
NCT00606437 -
Total Body Irradiation With Fludarabine Followed by Combined Umbilical Cord Blood (UCB) Transplants
|
Phase 1 | |
| Recruiting |
NCT05528887 -
Study of CAR-T Cell Therapy in the Treatment of Relapsed/Refractory Hematological Malignancies
|
Phase 1 | |
| Recruiting |
NCT05625971 -
Non-invasive MRD Assessment in Multiple Myeloma
|
||
| Active, not recruiting |
NCT02931942 -
Changing Over Time of Ascorbic Acid After Chemotherapy
|
||
| Active, not recruiting |
NCT05889221 -
Multicenter Phase 2 Study of Subcutaneous Isatuximab Plus Bortezomib, Lenalidomide and Dexamethasone in the Treatment of Newly Diagnosed Transplant Ineligible Multiple Myeloma
|
N/A | |
| Recruiting |
NCT03836690 -
Transfer of Effector Memory T Cells (Tem) Following Allogeneic Stem Cell Transplantation
|
Phase 1 | |
| Active, not recruiting |
NCT02542657 -
Ixazomib With Pomalidomide, Clarithromycin and Dexamethasone in Treating Patients With Multiple Myeloma
|
Phase 1/Phase 2 | |
| Completed |
NCT01191060 -
Study Comparing Conventional Dose Combination RVD to High-Dose Treatment With ASCT in the Initial Myeloma up to 65 Years
|
Phase 3 | |
| Completed |
NCT01279694 -
Trial of Carfilzomib Plus Melphalan and Prednisone in Elderly Untreated Patients With Multiple Myeloma (CARMYSAP)
|
Phase 1/Phase 2 | |
| Terminated |
NCT00983346 -
Effect of Low Dose Bortezomib on Bone Formation in Smoldering Myeloma Patients
|
Phase 2 | |
| Completed |
NCT00476294 -
Long-Term Follow Up Study for AMD3100 Patients
|
N/A |