Open Clinical Trials – Updated January 15, 2023

 

Immunotherapy AML/MDS NHL Multiple Myeloma
ALL Hematological Malignancies Post Transplant Supportive Care/Other
DiseaseTrial NumberName of TrialDrug & Link to clinicaltrials.gov
Immunotherapy
NHLNSH1231Managed 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
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
NSH1303A 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 originAB-101 NCT04673617
NSH1325Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCLNCT#03960840
NSH1329A 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
NSH1332A 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
NSH1334A 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 LymphomaDPX-Survivac
NCT04920617
NSH1339A 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
NSH1353A 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 MyelomaNSH1298Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Non-Conforming for Commercial Release bb2121-EAP-001bb2121-EAP-001
NSH1339A 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
NSH1351An Open-label Phase 1b Study of ORIC-533 in Patients with Relapsed or Refractory Multiple MyelomaORIC-533
NCT05227144
NSH1353A 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
AMLNSH1338A 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
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
NSH1325Phase I, open label, multicenter, dose escalation study of YTB323 in adult patients with CLL/SLL and DLBCLNCT03960840
Supportive Care
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 TransplantALVR105 NCT04390113
NSH1337Phase 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 TransplantNCT04390113
Respiratory VirusC434Phase 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 NSH1219Phase 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 DiseaseRituximab and Ibrutinib NCT04235036
Hematologic Malignancies, Leukemia, BMT and Supportive CareNSH1318A 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
LeukemiaNSH1331SY-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
NSH1338A 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
TransplantNSH1246Phase 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
NSH1347A Phase II Trial of Reduced Intensity Fludarabine and Total Body Irradiation-Based Conditioning Prior to Haploidentical Transplantation for Patients with Hematologic MalignanciesFludarabine
NCT04191187
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
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
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
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