| Immunotherapy | NHL | Multiple Myeloma | AML/MDS | ALL | SLL/CLL | |
| Hematological Malignancies | Hemorrhagic Cystitis | Respiratory Viruses | AML | Transplant | Post Transplant | Supportive Care/Other |
| Disease | Trial Number | Name of Trial | Drug & Link to clinicaltrials.gov |
|---|---|---|---|
| Immunotherapy | |||
| NHL | NSH1226 | An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | JCAR017 NCT03331198 |
| 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 | |
| NSH 1251 | A Phase 1, Multicenter, open-label study of CC-97540, C19-targeted NEX-T chimeric antigen receptor (CAR) T cells, in subjects with relapsed or refractory B-cell non-Hodgkin Lymphoma | CC-97540 NCT04231747 | |
| 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 (Open March 2021) | Expanded Access Protocol (EAP) for Patients receiving Lisocabtagene Maraleucel that is nonconforming for commercial release | Lisocabtagene Maraleucel NCT04400591 | |
| NSH1297 (Open February 2021) | A Phase 1/ 2 Open-Label Study to Evaluate the Safety and Efficacy of Loncastuximab Tesirine and Ibrutinib in Patients with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma | Loncastuximab Tesirine and Ibrutinib NCT03684694 | |
| Multiple Myeloma | NSH1216 | A Phase 3, Multicenter, Randomized, Open-Lable Study to Compare the Efficacy and Safety of BB2121 versus Daratumumab(DARA) in Combination with Relapsed and Refractory Multiple Myeloma (RRMM) (KarMM-3) | bb2121 NCT03651128 |
| NSH1224 | A Phase I, Open Label Study to Evaluate the Safety, Pharmacokinetic, Pharmacodynamic and Clinical Activity of PF-06863135, A B-Cell Maturation Antigen (BCMA) – CD3 Bispecific Antibody, in Patients with Relapsed/Refractory Advanced Multiple Myeloma (MM) | PF-06863135 NCT03269136 | |
| NSH1277 (Open February 2021) | A Phase 1, Open-Label, Multicenter Study to Evaluate the Safety of bb2121 in Subjects with High-Risk Newly Diagnosed Multiple Myeloma (KarMMa-4) | bb2121 NCT04196491 | |
| NSH1298 (Open March 2021) | NSH1298 (Open March 2021) | bb2121-EAP-001 | |
| AML/MDS | NSH1296 (Open April 2021) | Phase 1 Study of Escalating Single and Multiple Doses of Mana 312 (Multi Tumor-Associated Antigen T Cells) Administered to Adult Subjects with AML or MDS after Allogeneic Hematopoietic Stem Cell Transplant | Mana |
| C394 (Open April 2021) | BMTCTN 1803 Haplo-Identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDS | NCT04395092 | |
| 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 |
| 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 | |
| SLL/CLL | NSH1226 | An Open-Label, Phase 1 Safety and Phase 2 Randomized Study of JCAR017 in Subjects with Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma | JCAR017 NCT03331198 |
| Hematological Malignancies | NSH1164 | A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb® 14045 in Patients With CD123-Expressing Hematologic Malignancies | XmAB® 14045 NCT02730312 |
| Hemorrhagic Cystitis | C429 (Open March 2021) | 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 Viruses | C434 (Open Jan. 2021) | 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 |
| Leukemia, BMT and Supportive Care | |||
| AML | |||
| NSH1208 | A Phase 1 Trial to Evaluate the Potential Impact of Renal Impairment on the Pharmacokinetics and Safety of CPX-351 (Daunorubicin and Cytarabine) Liposome for Injection Treatment in Adult Patients with Hematologic Malignancies | Vyxeos NCT03555955 | |
| NSH1238 | A Phase Ib study of SEL120 in patients with Acute Myeloid Leukemia and High-Risk Myelodysplastic Syndrome | SEL120NCT04021368 | |
| NSH1260 | A Phase I, Parallel, Open-Label Study of the Safety and Tolerability, Pharmacokinetics, and Antileukemic Activity of ASTX660 as a Single Agent and in Combination with ASTX727 in Subjects with Acute Myeloid Leukemia | ASTX660 and ASTX727 NCTNCT04155580 | |
| C374 | A Phase III Randomized, Double-Blind Trial to Evaluate the Efficacy of Uproleselan administered with chemotherapy versus chemotherapy alone in patients with relapsed/refractory AML | Uproleselan(GMI-1271) NCT03616470 | |
| 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 |
|
| 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 | |||
| 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 |
| C369 | BMT CTN 1703 A Randomized, Multicenter, Phase III Trial of Tacrolimus/Methotrexate versus Post-Transplant Cyclophosphamide/ Tacrolimus/ Mycophenolate Mofetil in Non-Myeloablative/ Reduced Intensity Conditioning Allogeneic Peripheral Blood Stem Cell Transplantation | NCT03959241 |
|
| C401 | BMT CTN 1705 – A Randomized, Double-Blind, Placebo-Controlled Multicenter Phase III Trial of Alpha1-Antitrypsin (AAT) Combined with Corticosteroids Versus Corticosteroids Alone for the Treatment of High Risk Acute Graft-Versus-Host Disease (GVHD) Following Allogeneic Hematopoietic Stem Cell Transplant | Alpha1-Antitrypsin (AAT) NCT04167514 | |
| 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 | |
| C373 | BMT CTN 1702 Clinical Transplant-Related Long-term Outcomes of Alternative Donor Allogeneic Transplantation and Adult Patients | NCT03904134 | |
| C393 | BMT CTN 1704 Composite Health Assessment Model for Older Adults: Applying Pre-Transplant Comorbidity, Geriatric Assessment, and Biomarkers to Predict Non-Relapse Mortality after Allogeneic Transplantation (CHARM) | NCT03992352 | |