Open Clinical Trials - Updated April 15, 2024
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| NHL | NSH 1270 | 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 | |
| NSH1341 | A Phase 1 Safety and Efficacy Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma Delta (¿d) T Cells in Adults with B Cell Malignancies | ADI-001 Anti-CD20 CAR- NCT04911478 | |
| 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 | |
| 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 | |
| NSH1373 | Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Brexucabtagene Autoleucel | Brexucabtagene Autoleucel NCT05776134 | |
| 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 NCTNCT03233854 | |
| 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 |
| NSH1358 | A Phase II Study of CART-ddBCMA for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma | CART-ddBCMA NCT05396885 | |
| NSH1376 | Intermediate-Size Population Expanded Access Program (EAP) for Ciltacabtagene autoleucel (cilta-cel) Out-of-Specification (OOS) in patients with Multiple Myeloma | Ciltacabtagene autoleucel (cilta-cel) NCT05346835 | |
| 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 | |
| ALL | NSH1231 | Managed Access Program (MAP) to Provide Access to CTL019, for Acute Lymphoblastic Leukemia (ALL) or Large B-cell Lymphoma Patients Without Specification Leukapheresis Product and/or KManufactured Tisagenlecleucel Out of Specification for Commercial Release | CTL019 NCT3601442 |
| 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 | |
| Supportive Care | |||
| Hematologic Malignancies, Leukemia, BMT and Supportive Care | |||
| Leukemia | NSH1331 | SY-1425 in Combination with Venetoclax and Azacitidine in Adult Patients with RARA-positive, Previously Untreated AML who are ineligible for Standard Induction Therapy | SY-1425 NCT04905407 |
| Transplant | |||
| 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 NCT04191187 |
| 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 |
| Supportive Care/Other | |||
| NSH721 | NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository | NCT00495300 (sample) NCT01166009 (database) |
|
| 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 | |
| NSH1385 | Phase II Trial of Belumosudil and Rituximab for the Primary Treatment of Extensive Chronic Graft-versus-Host Disease | Belumosudil and Rituximab NCT06046248 |