Open Clinical Trials - Updated December 2024
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| NHL | NSH1270 | A Phase 1/2a, Open-Label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR0191 in Subjects with Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) and r/r B-cell Acute Lymphoblastic Leukemia (B-ALL) | PBCAR0191 NCT03666000 |
| NSH1303 | A Multi-Center, Open-Label, Phase 1 /2 Clinical Trial to Evaluate the Safety and Anti-Tumor Activity of AB-101 Monotherapy and AB-101 plus Rituximab in Patients with Relapsed/Refractory NHL of B-Cell origin | AB-101 NCT04673617 | |
| NSH1329 | A Phase 1b Open-label Study to Evaluate the Safety and Anti-cancer activity of Loncastuximab Tesirine in Combination with Other Anti-Cancer Therapies in Patients with Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma (LOTIS 7) | Loncastuximab Tesirine NCT04970901 | |
| NSH1370 | A Phase 1, Multicenter, Open-Label Study of CB-010, a CRISPR-Edited Allogeneic Anti-CD19 CAR-T Cell Therapy in Patients with Relapsed/Refractory B Cell Non-Hodgkin Lymphoma (ANTLER) | CB-010 NCT04637763 | |
| NSH1381 | An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of CRG-022, a CD22-Directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Participants with Relapsed/Refractory Large B-Cell Lymphoma After CD19-Directed CAR T-cell Therapy | CRG-022 NCT05972720 | NSH1400 | A Phase 1 Open-Label, Multicenter Study Evaluating the Safety and Efficacy of KITE-363 or KITE-753, Autologous Anti CD19/CD20 CAR T-cell Therapies, in Subjects with Relapsed and/or Refractory B-cell Lymphoma | KITE-363 or KITE-753 NCT 04989803 |
| Multiple Myeloma | NSH1357 | Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral irreversible menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM) | BMF-219 NCT05153330 |
| NSH1382 | A Phase 1 Multicenter, Open-Label Study to Determine the Recommended Dose and Schedule, and Evaluate the Safety and Preliminary Efficacy of BMS-986393 in Combination with Alnuctamab, Mezigdomide, or Iberdomide in Participants with Relapsed and/or Refractory Multiple Myeloma | BMS-986393 NCT06121843 | |
| NSH1396 | A Phase I/II, Open-Label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Preliminary Efficacy of Anti-GPRC5D CAR-T cell Product (OriCAR-017) in Subjects with Relapsed/Refractory Multiple Myeloma | OriCAR-017 NCT06271252 | |
| C-554 | A Phase 2, Open-Label, Multicenter Study of BMS-986393, a GPRC5D-directed CAR T Cell Therapy in Adult Participants with Relapsed or Refractory Multiple Myeloma (QUINTESSENTIAL) | BMS-986393 NCT06297226 | |
| AML | NSH1357 | Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral irreversible menin inhibitor, in adult patients with acute leukemia (AL), diffuse large B-cell lymphoma (DLBCL), and multiple myeloma (MM) | BMF-219 NCT05153330 |
| NSH1389 | A Phase I, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients with Relapsed/Refractory Acute Myeloid Leukemia (AMpLify) | CB-012 NCT06128044 | |
| NSH1406 | A Phase Ia/Ib Study of NMS-03597812 in Adult Patients with Relapsed/Refractory Acute Myeloid Leukemia including patients with TP53 mutations | NMS-03597812 NCT06549790 | |
| ALL | NSH1325 | Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL | NCT03960840 |
| NSH1354 | Intrathecal Chemoprophylaxis to Prevent Neurotoxicity associated with Blinatumomab therapy for Acute Lymphoblastic Leukemia | Blinatumomab NCT05519579 |
|
| CLL | C532 | A Phase 1 study evaluating SC291, a hypoimmune allogeneic CD19-directed CAR T cell therapy, in relapsed and/or refractory B-cell malignancies (ARDENT) | SC291 NCT05878184 |
| NSH1359 | An Open-Label, Phase 1/2 Study Evaluating the Safety, Efficacy, and Cellular Kinetics/Pharmacodynamics of ALLO-501A, an Anti-CD19 Allogeneic CAR T Cell Therapy, and ALLO-647, an Anti-CD52 Monoclonal Antibody, in Subjects with Relapsed/Refractory Large B-Cell Lymphoma | ALLO-501A and ALL)-647 NCT04416984 | |
| Sickle Cell and Hemoglobinopahties | NSH1356 | A Non-Myeloablative Conditioning and Transplantation of Partially HLA-Mismatched and HLA-Matched Bone Marrow for Patients with Sickle Cell Disease and Other Hemoglobinopathies | NCT01850108 |
| Hematologic Malignancies | NSH1347 | A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haploidentical Transplantation for Patients with Hematologic Malignancies | Fludarabine NCT05417971 |
| Aplastic Anemia | NSH1158 | A Study of T Cell Replete, HLA-Mismatched Bone Marrow Transplantation With Post-Transplant Cyclophosphamide as a Front-Line Therapy for Patients With Severe Aplastic Anemia Lacking HLA-Matched Related Donor | Fludarabine Cyclophos NCT02828592 |
| Allogeneic Donors | NSH1166 | Infusion of CD34+ Selected Donor Hematopoietic Stem Cells/Bone Marrow Using the CliniMACS Humanitarian Use Device Protocol | NONE |
| Post Transplant | |||
| NSH1246 | Phase II Trial Evaluating the Efficacy and Safety or Sargramostim Post Infusion of T-Replete HLA Mismatched Peripheral Blood Haploidentical Stem Cells with Post Transplant Cyclophosphamide | Sargamostim NCT04237623 | |
| Multiple Myeloma | C389 | Phase III Study of Daratumumab/rHuPh20 (NSC-810307) Plus Lenalidomide or Lenalidomide as Post Autologous Stem Cell Transplant Maintenance Therapy in Patient with Multiple Myeloma (MM) using Minimal Residual Disease to Direct Therapy Duration (Dramatic Study). | Daratumumab/rHuPh20 (NSC-810307) NCT04071457 |
| GVHD | NSH1385 | Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-Host Disease | Belumosudil and Rituximab NCT06046248 |
| NSH1398 | A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Investigate the Efficacy and Safety of CYP-001 in Combination with Corticosteroids vs. Corticosteroids Alone for the Treatment of High-Risk Acute Graft Versus Host Disease | CYP-001 NCT05643638 | |
| NSH1405 | An Open-Label, Expanded Access Program of Axatilimab for the Treatment of Chronic Graft-Versus-Host Disease in Participants Who Have Received at Least 2 Lines of Systemic Therapy | Axatilimab NCT05544032 | |
| C566 | Phase 2 Open Label Prospective Dose-Ranging Clinical Trial with Escalation and Expansion Cohorts to Evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Dosing, and Efficacy of RLS-0071 for the Treatment of Hospitalized Patients with Steroid-Refractory Acute Graft-versus-Host Disease | RLS-0071 NCT06343792 | |
| Supportive Care/Other | |||
| NSH721 | NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository | NCT00495300 (sample) NCT01166009 (database) |
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| NSH943 | A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other Indications | NCT01351545 | |
| NSH995 | A Multicenter Safety Study of unlicensed, Investigational Cryopreserved Cord Blood Units (CBUs) Manufactured by the National Cord Blood Program (NCBP) and Provided for Unrelated Hematopoietic Stem Cell Transplantation of Pediatric and Adult Patients | NCT01656603 | |
| NSH1411 | Expanded access intermediate size treatment protocol: Pritelivir for immunocompromised subjects with treatment-resistant Herpes Simplex Virus type 1 or 2 | NCT05844436 | |
| C552 | Placebo-Controlled and Randomized Phase 2 Trial of CMV-MVA Triplex Vaccination in HLA-Matched Related Stem Cell Donors to Enhance CMV-Specific Immunity and Prevent CMV Viremia in Recipients After Hematopoietic Stem Cell Transplant | NCT06059391 |