Open Clinical Trials – Updated May 15, 2021

Immunotherapy NHL Multiple Myeloma AML/MDS ALL SLL/CLL
Hematological Malignancies Hemorrhagic Cystitis AML Transplant Post Transplant Supportive Care/Other
DiseaseTrial NumberName of TrialDrug & Link to clinicaltrials.gov
Immunotherapy
NHLNSH1226An 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
NSH1231Managed 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 ReleaseCTL019NCT3601442
NSH 1251A 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 LymphomaCC-97540 NCT04231747
NSH1261A Phase 1 Multidose Study to Evaluate the Safety and Tolerability of XmAb®13676 in Patients with CD20-Expressing Hematologic Malignancies XmAb®13676 NCT02924402
NSH 1270A 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
NSH1282Expanded Access Protocol (EAP) for Patients receiving Lisocabtagene Maraleucel that is nonconforming for commercial release Lisocabtagene Maraleucel NCT04400591
NSH1297 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 MyelomaNSH1216A 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
NSH1277 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 June 2021)NSH1298 (Open March 2021)bb2121-EAP-001
AML/MDSNSH1296Phase 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 June 2021) BMTCTN 1803 Haplo-Identical Natural Killer (NK) Cells to Prevent Post-Transplant Relapse in AML and MDSNCT04395092
ALLNSH1231Managed 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 ReleaseCTL019 NCT3601442
NSH1270A 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/CLLNSH1226An 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 MalignanciesNSH1164
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 C429A 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
Leukemia, BMT and Supportive Care
AML
 NSH1208A 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
NSH1246Phase II trial evaluating the Efficacy and Safety or Sargramostim Post Infusion of T-Replete HLA mismatched Peripheral Blood Haploidentical Stem Cells with Post Transplant cyclophosphamideSargamostim
NCT04237623
Aplastic AnemiaNSH1158A 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 DonorFludarabine
Cyclophos NCT02828592
Allogeneic DonorsNSH1166Infusion of CD34+ Selected Donor Hematopoietic Stem Cells/Bone Marrow Using the CliniMACS Humanitarian Use Device Protocol
NONE
 Post Transplant
GVHDNSH1219
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
Multiple MyelomaC389
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
NSH721NMDP Recipient Consent for Participation in Registry, Research Database, and Research Sample Repository NCT00495300 (sample)
NCT01166009 (database)
 NSH943A Multicenter Access and Distribution Protocol for Unlicensed Cryopreserved Cord Blood Units (CBUs) for Transplantation in Pediatric and Adult Patients With Hematologic Malignancies and Other IndicationsNCT01351545
NSH995A 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
C373BMT 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