Joint Clinical Trials Office

A Phase 3 Randomized Study Comparing Teclistamab in Combination with Daratumumab SC and Lenalidomide (Tec-DR) and Talquetamab in Combination with Daratumumab SC and Lenalidomide (Tal-DR) versus Daratumumab SC, Lenalidomide, and Dexamethasone (DRd)

This clinical trial is for men and women with newly diagnosed multiple myeloma who are not considered a candidate for high-dose chemotherapy with autologous stem cell transplant (ASCT).
   
The purpose of this study is to compare the efficacy of teclistamab in combination with daratumumab and lenalidomide (Tec-DR) and talquetamab in combination with daratumumab and lenalidomide (Tal-DR) versus daratumumab, lenalidomide, dexamethasone (DRd).
   

Phase 1 Trial of CA-4948 in Combination with Pembrolizumab to Overcome Resistance to PD-1/PD-L1 Blockade in Metastatic Urothelial Cancer

The purpose of this study is to test the safety of a drug called CA-4948 in combination with pembrolizumab for patients with metastatic urothelial cancer. This study tests different doses of the drug to determine the highest dose with manageable side effects in people.

A Phase IV Study Evaluating the Safety and Efficacy of neffy or Intramuscular Adrenalin in Patients with Allergic Reactions after Oral Food Challenge or Allergen Immunotherapy (EPI R01)

The purpose of this research is to see if Neffy nasal spray works as well as injected epinephrine for treatment of serious allergic reaction known as anaphylaxis. 

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Expanded Access Treatment Protocol for Bulevirtide

 The primary objective of this expanded access program (EAP) is to address a significant patient unmet medical need by providing access to bulevirtide (BLV [GS-4438], Hepcludex®) 10 mg for patients in the United States of America (USA) living with chronic hepatitis delta virus (HDV) infection (CHD).

A Phase 2 Study of Blinatumomab in Combination with Chemotherapy for Infants with Newly Diagnosed Acute Lymphoblastic Leukemia with Randomization of KMT2A-Rearranged Patients to Addition of Venetoclax

The purpose of this study is to test whether it is feasible to include the study drugs, blinatumomab and venetoclax, in the chemotherapy regimen used to treat infants with KMT2A- ALL. The study will test the good and bad effects of the study drugs. Blinatumomab and venetoclax in combination with standard chemotherapy could help treat the leukemia.

A Phase III, Open-label, Randomised Study of Osimertinib With or Without Dato-DXd as First-line Treatment in Participants With Epidermal Growth Factor Receptor Mutation-positive, Locally Advanced or Metastatic Non-small Cell Lung Cancer

This clinical trial is for adults who have been diagnosed with non-small cell lung cancer (NSCLC).

A Phase 3, Randomized, Open-Label Study to Compare the Efficacy and Safety of Anitocabtagene Autoleucel Versus Standard of Care Therapy in Participants With Relapsed/Refractory Multiple Myeloma

This clinical trial is for adults who have relapsed or refractory multiple myeloma (either their disease has come back, or it is no longer responding to their current treatment) and standard therapies available to treat their disease may have limited effectiveness.
   

The Magenta Elevate™ High-Risk PCI Pivotal Study (Elevate III)

The purpose of this study is to evaluate the safety and effectiveness of the Elevate System for patients needing non-emergent percutaneous coronary intervention (PCI).

The Elevate System is an investigational heart pump device, which means it has not been approved by the U.S. Food and Drug Administration (FDA). It is being compared with an already approved heart pump device called the Impella System. The Impella System is approved for patients having HR-PCI.

Endocardial Delivery of XC001 Gene Therapy for Refractory Angina Coronary Treatment: A 26-Week (with 26 Week Extension) Phase 2b Randomized, Multi-Center, Double-Blind, Sham Controlled Study to Evaluate Efficacy and Safety (The EXACT-2 Trial)

The purpose of this study is to evaluate the safety and efficacy of percutaneous endovascular catheter-facilitated intramyocardial delivery of XC001 in treating refractory angina compared to standard treatment.