Open Clinical Trials – Updated April 15, 2022

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
NHLNSH1170A 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
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
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
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
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
Multiple MyelomaNSH1298Expanded Access Protocol (EAP) for Subjects Receiving Idecabtagene Vicleucel That is Non-Conforming for Commercial Release bb2121-EAP-001bb2121-EAP-001
NSH1304An 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 MyelomaNCT04855136
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
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
Supportive Care and GVHD 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
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 Disease
Rituximab and Ibrutinib
NCT04235036
Leukemia, BMT and Supportive Care
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
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
GVHDNSH1317
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
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