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Joint Clinical Trials Office

A Phase 1, Multicenter, Open-Label Study of CB-012, a CRISPR-Edited Allogeneic Anti-CLL-1 CAR-T Cell Therapy in Patients With Relapsed/Refractory Acute Myeloid Leukemia

This is a Phase 1 study to evaluate the safety, preliminary efficacy, and pharmacokinetics, of CB-012 (the study treatment) in adults with acute myeloid leukemia (AML) that has come back after prior treatment (relapsed) or did not respond or is no longer responding to other treatment (refractory).

CB-012 is an allogeneic chimeric antigen receptor (CAR-T) cell therapy that targets C-type lectin-like molecule-1 (CLL-1). CB-012 is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA).

Radioembolization Oncology Trial Utilizing Transarterial Eye90 (ROUTE 90) for the Treatment of Hepatocellular Carcinoma (HCC)

This is a prospective, multi-center, open-label study to evaluate the effectiveness and safety of Eye90 microspheres® in the treatment of participants with unresectable Hepatocellular Carcinoma (HCC, a.k.a. liver cancer).

Eye90 is comprised of tiny glass beads containing yttrium-90 (Y90), a radioactive material. The beads are delivered in and around the tumor(s) through a tiny catheter placed through the artery of the groin or wrist and into one or more branches of the artery of the liver under x-ray camera guidance.

A Randomized Phase II Trial of Consolidation Therapy Following CD19 CAR T-Cell Treatment For Relapsed/Refractory Large B-Cell Lymphoma or Grade IIIB Follicular Lymphoma

This study is being done to determine if we can lower the chance of diffuse large B-cell lymphoma (DLBCL) growing or spreading by adding treatment to the usual therapy.

A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score ≤ 25 (OFSET)

NRG-BR009, also known as the “OFSET” trial, is a clinical study trying to determine whether the chance of breast cancer returning would be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian function suppression.

A Phase III, Open-label, Randomised Study of Neoadjuvant Datopotamab Deruxtecan (Dato-DXd) Plus Durvalumab Followed by Adjuvant Durvalumab With or Without Chemotherapy Versus Neoadjuvant Pembrolizumab Plus Chemotherapy Followed by Adjuvant Pembrolizumab

This clinical trial is for adult participants who have triple-negative breast cancer (TNBC).
   
The purpose of this study is to evaluate the safety and effectiveness of the study drug datopotamab deruxtecan (also called Dato-DXd) given in combination with another investigational drug called durvalumab.
   
Dato-DXd and Durvalumab are experimental, which means that they are being tested and are not approved by the United States Food and Drug Administration (FDA).
   

A Phase 1, Open-Label, Safety and Tolerability Study of INCB057643 in Participants With Myelofibrosis and Other Advanced Myeloid Neoplasms

This clinical trial is for men and women with myelofibrosis.
   
The purpose of this study is to test the safety and tolerability of INCB057643 in combination with ruxolitinib on people with myelofibrosis. 
   

A Phase III, Open-Label, Randomised Study to Assess the Efficacy and Safety of Camizestrant (AZD9833, a Next-Generation, Oral Selective Estrogen Receptor Degrader) Versus Standard Endocrine Therapy (Aromatase Inhibitor or Tamoxifen) as Adjuvant Treatment

This is a Phase III open-label study to assess if camizestrant improves outcomes compared to standard adjuvant endocrine therapy for patients with ER+/HER2- early breast cancer with intermediate-high or high risk for disease recurrence who completed definitive locoregional therapy (with or without chemotherapy).

Camizestrant is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

Expanded Access Study for the Treatment of Patients with Commercially Out-of-Specification Axicabtagene Ciloleucel

The goal of this study is to provide access to axicabtagene ciloleucel for patients diagnosed with large B-cell lymphoma and follicular lymphoma approved for treatment with axicabtagene ciloleucel, that is otherwise out of specification for commercial release.

Axicabtagene ciloleucel is considered investigational, which means it has not been approved by the U.S. Food and Drug Administration (FDA). 

Local Methotrexate Injections for the Treatment of Nail Psoriasis

This study is evaluating the efficacy of methotrexate injections for treatment of nail psoriasis.

Participants in this study will receive three injections into three different nails: one nail will receive methotrexate, one nail will receive triamcinolone acetonide, and one nail will receive a placebo (no medication) injection.

Triamcinolone acetate and methotrexate are both approved by the U.S. Food and Drug Administration, however, nail injections for nail psoriasis are not an approved use of methotrexate by the FDA.

Technology dRiven Enhancement to Engage & Connect (TREE-Connect)

We invite you to participate in the TREE-Connect Study. 
   
This study aims to develop a hybrid intervention that combines a remote psychotherapy with a novel mobile health app (TREE-Connect). Together, this combined intervention can lead to improvement in depression and social connectedness in mid- and late-life.