Clinical Trials

The clinical trials listed below are for informational purposes only and are not endorsed by the AST. More information on clinical trials can be found in our clinical trials brochure. For information about posting a clinical trial, contact JoAnn Gwynn at jgwynn@myast.org.

Clinical Trials for Kidney Recipients

• Tabelecleucel for Solid Organ Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE)
  Sponsor: Atara Biotherapeutics
  Organ Type: All organs
  Ages Accepted: All ages
  Genders Accepted: Both male and female
  Expected Study Completion Date: Monday, November 30, 2020
  Other Requirements
  COVID-19 Update: The ALLELE trial remains open and is currently enrolling patients. Please visit clinicaltrials.gov for information regarding sites and investigators.
   
• Efficacy and Safety of Human Plasma-derived C1-esterase Inhibitor as Adjunctive Treatment For Refractory Antibody-Mediated Rejection (ARMOR) in Adult Renal Transplant Recipients
  Sponsor: CSL Behring
  Organ Type: Kidney
  Ages Accepted: 18+
  Genders Accepted: Both male and female 
  Expected Study Completion Date: Thursday, January 15, 2026 
  Enrollment for the ongoing Phase 3 study of CSL842 in refractory antibody mediated rejection is currently on hold due to the COVID-19 pandemic. Subjects currently enrolled in the trial will continue to be followed by their transplant centers and should follow any instructions provided to them by the study site staff. CSL Behring is working closely with every center to ensure continued safe participation in the clinical trial. Enrollment will open as soon as feasible given the global impact of the pandemic.
   
• A Phase 3, Randomized, Multi-center, Open-label, Controlled Trial to Assess the Efficacy and Safety of Cellular Immunotherapy With MDR-101 for Induction of Immune Tolerance in Recipients of HLA-matched, Living Donor Kidney Transplants
  Sponsor: Medeor Therapeutics, Inc.
  Organ Type: Kidney
  Ages Accepted: Age ≥18 and ≤70 years
  Genders Accepted: Both male and female
  Expected Study Completion Date: January, 2022
   
• A Partially-blinded, Active-controlled, Multicenter, Randomized Study Evaluating Efficacy, Safety, Tolerability, Pharmacokinetic (PK) and Pharmacodynamic (PD) of an Anti-CD40 Monoclonal Antibody, CFZ533, in de Novo and Maintenance Kidney Transplant Recipients (CIRRUS I)
  Sponsor: Novartis 
  Organ Type: Kidney
  Ages Accepted: 18+
  Genders Accepted: Both male and female
  Expected Study Completion Date: April 15, 2026

Clinical Trials for Other Organ Types

• Tabelecleucel for Solid Organ Transplant Subjects With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease (EBV+ PTLD) After Failure of Rituximab or Rituximab and Chemotherapy (ALLELE)
  Sponsor: Atara Biotherapeutics
  Organ Type: All organs
  Ages Accepted: All ages
  Genders Accepted: Both male and female
  Expected Study Completion Date: Monday, November 30, 2020
  Other Requirements
  COVID-19 Update: The ALLELE trial remains open and is currently enrolling patients. Please visit clinicaltrials.gov for information regarding sites and investigators.
   
• A Phase 3, Multicenter, Randomized, Open-label, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Treatment Compared to Investigator-assigned Treatment in Transplant Recipients With Cytomegalovirus (CMV) Infections That Are Refractory or Resistant (RR) to Treatment With Ganciclovir, Valganciclovir, Foscarnet, or Cidofovir
  Sponsor: Takeda Pharmaceutical Company Limited
  Organ Type: Hematopoietic Stem Cell Transplant, All organs
  Ages Accepted: ≥12 years of age
  Genders Accepted: Both male and female
  Expected Study Completion Date: Tuesday, September 29, 2020
  Other Requirements
   
• A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Study to Assess the Efficacy and Safety of Maribavir Compared to Valganciclovir for the Treatment of Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant (HSCT) Recipients
  Sponsor: Takeda Pharmaceutical Company Limited
  Organ Type: Hematopoietic Stem Cell Transplant
  Ages Accepted: ≥16 years of age
  Genders Accepted: Both male and female
  Expected Study Completion Date: Tuesday, August 13, 2021
  Other Requirements
  
   
• A 12-month, Open-label, Multicenter, Randomized, Safety, Efficacy, Pharmacokinetic (PK) and Pharmacodynamic (PD) Study of an Anti-CD40 Monoclonal Antibody, CFZ533 vs. Standard of Care Control, in Adult de Novo Liver Transplant Recipients With a 12-month Additional Follow-up (CONTRAIL I)
  Sponsor: Novartis 
  Organ Type: Liver
  Ages Accepted: 18 years to 70 years 
  Genders Accepted: Both male and female
  Expected Study Completion Date: September 23, 2022