| Immunotherapy | AML/MDS | NHL | Multiple Myeloma |
| ALL | Hematological Malignancies | Post Transplant | Supportive Care/Other |
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| NHL | NSH1170 | A Phase 1, Multicenter, Open-Label Study of JCAR017, CD19-Targeted Chimeric Antigen Receptor (CAR) T Cells, in Relapsed and Refractory (R/R) B-Cell Non-Hodgkin Lymphoma | JCAR017 NCT02631044 |
| 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 Manufactured Tisagenlecleucel Out of Specification for Commercial Release | CTL019NCT3601442 | |
| NSH1261 | A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb®13676 in Patients with CD20-Expressing Hematologic Malignancies | XmAb®13676 NCT02924402 | |
| 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 | |
| NSH1282 | Expanded Access Protocol (EAP) for Patients receiving Lisocabtagene Maraleucel that is nonconforming for commercial release | Lisocabtagene Maraleucel NCT04400591 | |
| 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 |
|
| NSH1332 | A Phase 2 Open-label Clinical Study to Evaluate the Efficacy and Safety of Zilovertamab Vedotin (MK-2140) in Participants With Relapsed or Refractory Diffuse Large B-Cell Lymphoma | MK-2140 NCT05144841 |
|
| NSH1334 | A Phase 2b, Open-label, Multicenter, Randomized, Parallel-Group, Two-Stage, Study of an Immunotherapeutic Treatment, DPX-Survivac Alone, or in Combination with Pembrolizumab with and without Intermittent Low Dose Cyclophosphamide, in Subjects with Relapsed/Refractory Diffuse Large B-Cell Lymphoma | DPX-Survivac NCT04920617 |
|
| NSH1340 | FT516-101 A Phase 1 study of FT516 as Monotherapy in Relapsed/Refractory Acute Myelogenous Leukemia and in combination with Monoclonal Antibodies in Relapsed/Refractory B Cell Lymphoma | FT516 NCT04920617 | |
| C459 | BMT CTN 1903 Administration of HIV-Specific T cells to HIV+ Patients Receiving High Dose Chemotherapy Followed by Autologous Stem Cell Rescue | HIV Antigen-specific T-cells Targeting HST-NEETs NCT04975698 |
|
| Multiple Myeloma | NSH1298 | Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Non-Conforming for Commercial Release bb2121-EAP-001 | bb2121-EAP-001 |
| NSH1304 | An exploratory Phase 1/2 Trial to Determine Recommended Phase 2 Dose (RP2D), Safety and Preliminary Efficacy of BB2121(ide-cel) Combinations in Subjects with Refractory/Relapsed Multiple Myeloma | NCT04855136 | |
| 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 |
| Supportive Care | |||
| Hemorrhagic Cystitis | C429 | A Phase 3 Multicenter, Double-Blind, Placebo-Controlled Trial of Viralym-M (ALVR105) for the treatment of patients with Virus-Associated Hemorrhagic Cystitis after Allogeneic Hematopoietic Cell Transplant | ALVR105 NCT04390113 |
| Respiratory Virus | C434 | Phase 1/2, Double-Blind, Placebo-Controlled, Dose Escalation and Expansion Study of ALVR106 for the Treatment of High-Risk Patients With Respiratory Viral Infections After Hematopoietic Cell Transplant | ALVR105 NCT04933968 |
| GVHD | NSH1219 | Phase II Trial Evaluating the Safety and Efficacy of Combined CD20- and BTK-Targeted B Cell Depleting Therapy with Rituximab and Ibrutinib in the Primary Treatment of Chronic Graft-Versus Host Disease | Rituximab and Ibrutinib NCT04235036 |
| Hematologic Malignancies, Leukemia, BMT and Supportive Care | NSH1318 | A Phase 1a/1b Dose-Escalation and Expansion Trial of TT-622 in Patients with Advanced Hematologic Malignancies, including Lymphoma, Leukemia, and Multiple Myeloma | TT-622 NCT03530683 |
| 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 |
| NSH1338 | A Phase 1b/2 study of the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of the selective SYK inhibitor lanraplenib (LANRA) in combination with the FLT3 inhibitor gilteritinib, in patients with FLT3-mutated relapsed or refractory AML | YK inhibitor lanraplenib (LANRA) NCT05028751 |
|
| 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 |
| 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 | |||
| 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 | NSH1317 | A Phase 2, Open-label, Randomized, Multicenter Study to Evaluate the Efficacy, Safety and Tolerability of Axatilimab at 3 Different Doses in Patients with Recurrent or Refractory Active Chronic Graft Versus Host Disease who have Received at least 2 Lines of Systemic Therapy | Axatilimab NCT04710576 |
| C401 | A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha 1 – Antitrypsin (AAT) Combined with Corticosteroids vs. Corticosteroids Alone for the Treatment of High Risk Acute GVHD Following Allogeneic HSCT | Alpha 1-Antitrpsin (AAT) NCT04167514 |
|
| 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 | |