| 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 | 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 | |
| NSH1325 | Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCL | NCT#03960840 | |
| 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 |
|
| NSH1339 | A Phase 1, Open-Label, Dose-Escalation and Expansion, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients with Relapsed or Refractory Multiple Myeloma or Non-Hodgkin Lymphoma | NCT04017130 | |
| NSH1353 | A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma. | SG2501 NCT05293912 |
|
| 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 |
| NSH1339 | A Phase 1, Open-Label, Dose-Escalation and Expansion, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of MT-0169 in Patients with Relapsed or Refractory Multiple Myeloma or Non-Hodgkin Lymphoma | MT-0169 NCT04017130 |
|
| NSH1351 | An Open-label Phase 1b Study of ORIC-533 in Patients with Relapsed or Refractory Multiple Myeloma | ORIC-533 NCT05227144 |
|
| NSH1353 | A Phase Ia/Ib, First-in-Human, Open-Label, Multicenter, Dose Escalation and Dose Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Preliminary Efficacy of SG2501 in Subjects with Relapsed or Refractory Hematological Malignancies and Lymphoma. | NCT05293912 | |
| AML | 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 | NCT05028751 |
| 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 | |
| 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 |
| NSH1337 | Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of ALVR105 (Viralym-M) Compared to Placebo for the Prevention of AdV, BKV, CMV, EBV, HHV-6 and JCV Infection and/or Disease, in High-Risk Patients After Allogeneic Hematopoietic Cell Transplant | 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 |
| 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 | |