Taimur Sher, M.B.B.S., M.D.

Closed for Enrollment

• 54767414AMY3001: A Randomized Phase 3 Study to Evaluate the Efficacy and Safety of Daratumumab in Combination with Cyclophosphamide, Bortezomib and Dexamethasone (CyBorD) Compared With CyBorD Alone in Newly Diagnosed Systemic AL Amyloidosis (CyBorD) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the efficacy and safety of daratumumab plus cyclophosphamide, bortezomib and dexamethasone (CyBorD) compared with CyBorD alone in treatment of newly diagnosed amyloid light chain (AL) amyloidosis participants.

• A Phase 1, Open-label, Dose Escalation, Safety and Tolerability Study of INCB040093 in Subjects With Previously Treated B-Cell Malignancies Jacksonville, Fla., Rochester, Minn. The study will be conducted in three parts. Part 1 is a dose escalation phase to determine the maximum tolerated dose (MTD) of INCB040093, a PI3Kδ inhibitor, or a tolerated, pharmacologically active dose; Part 2 will evaluate the combination of INCB040093 and INCB039110, a JAK1 inhibitor, to determine the MTD of the combination or a tolerated dose that produces substantial pharmacologic inhibition of both targets; Part 3 will further evaluate the chosen doses of INCB040093 alone and in combination with INCB039110 in subjects with relapsed/refractory B-cell malignancies.
• A Phase 1b Dose Escalation Study to Assess the Safety of AFM13 in Combination With Pembrolizumab in Patients With Relapsed or Refractory Classical Hodgkin Lymphoma (KEYNOTE- 206) Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to establish a dosing regimen for the combination therapy of AFM13 and pembrolizumab (MK-3475) in patients with relapsed or refractory (R/R) Hodgkin Lymphoma (HL) and to assess the safety and tolerability of this combination therapy.

• A Phase 2b, Randomized, Double-blind, Placebo-controlled Study of NEOD001 in Previously Treated Subjects With Light Chain (AL) Amyloidosis Who Have Persistent Cardiac Dysfunction (PRONTO) Rochester, Minn., Jacksonville, Fla.

  This is a global, multicenter, Phase 2b, randomized, double-blind, placebo-controlled, two-arm, parallel-group efficacy and safety study of NEOD001 as a single agent administered intravenously in adults with AL amyloidosis who had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

• A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment-Naïve Patients with Mayo Stage IIIb AL Amyloidosis Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine if CAEL-101 and treatment for plasma cell dyscrasia improves overall survival in Mayo stage IIIb AL amyloidosis patients who are treatment naïve compared to treatment for plasma cell dyscrasia alone, and to evaluate the safety and tolerability of CAEL-101 in combination with treatment for plasma cell dyscrasia.

• A Phase 3, Randomized, Multicenter, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study of NEOD001 Plus Standard of Care Versus Placebo Plus Standard of Care in Subjects With Light Chain (AL) Amyloidosis (VITAL) Jacksonville, Fla., Rochester, Minn.

  This is a multi-center, international, randomized, double-blind, placebo-controlled, two-arm efficacy and safety study in subjects newly diagnosed with AL amyloidosis. Subjects will remain on-study until study completion, which will occur when all primary endpoint events (all-cause mortality or cardiac hospitalizations) have been reached.

• A Phase I Dose Escalation Study of the Safety and Pharmacokinetics of LAM-002A (Apilimod Dimeyslate Capsules) Administered Orally in Subjects with Relapsed or Refractory B-Cell Non-Hodgkin's Lymphoma (LAM-002A/NHL) Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to evaluate the safety, tolerability, drug/body interactions, and preliminary activity of LAM-002A for the treatment of patients who have B-cell non-Hodgkin's lymphoma that has returned or is resistant to treatment. 

• A Phase IIb, Randomized, Double-Blind, Placebo-Controlled Study of NEOD001 in Previously Treated Subjects with Light Chain Amyloidosis who have Persistent Cardiac Dysfunction (PRONTO) Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to assess the effectiveness and safety of NEOD001 administered intravenously in adults with light chain amyloidosis who have had a hematologic response to previous treatment for their amyloidosis (e.g., chemotherapy, autologous stem cell transplant [ASCT]) and have persistent cardiac dysfunction.

• ADCT-301-201 - A Phase 2, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of Camidanlumab Tesirine (ADCT-301) in Patients With Relapsed or Refractory Hodgkin Lymphoma Jacksonville, Fla., Rochester, Minn., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to evaluate the clinical effectiveness and safety of Camidanlumab Tesirine (ADCT-301) in participants with relapsed or refractory Hodgkin Lymphoma (HL).

• An Open Label, Phase 2 Study to Evaluate Efficacy and Safety of Daratumumab in Relapsed or Refractory Mantle Cell Lymphoma, Diffuse Large B-Cell Lymphoma, and Follicular Lymphoma Jacksonville, Fla., Rochester, Minn.

  The purpose of this study is to assess overall response rate, including complete and partial response, of daratumumab in patients with relapsed or refractory mantle cell lymphoma, diffuse large B-cell lymphoma, and follicular lymphoma.

• CAEL101-302 A Phase 3, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of CAEL-101 and Plasma Cell Dyscrasia Treatment Versus Placebo and Plasma Cell Dyscrasia Treatment in Plasma Cell Dyscrasia Treatment Naïve Patients With Mayo Stage IIIa AL Amyloidosis (CAEL101-302) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  The purpose of this study is to determine if CAEL-101 improves the overall survival in patients with cardiac AL Amyloidosis.

   

   

• Examining the In-Vitro Cytotoxic Activity of Lenalidomide in Combination with the Bispecific CD30/CD16a Therapeutic Monoclonal Antibody, AFM13 Jacksonville, Fla.

  The purpose of this study is to determine whether lenalidomide enhances the activation potential of NK cells derived from Hodgkin’s lymphoma patients. The study also aims to determine if lenalidomide treated NK cells are more efficient in killing CD30+ tumor cells  (cancer cell lines) in combination with an investigational agent (AFM13, CD30/CD16a mAb, Affimed Therapeutics, Germany), which engages both the CD30+ tumor cell and CD16a+ NK cells.

• Phase 2 Single-Arm, Open-Label Study of Nivolumab in Patients With Relapsed or Refractory Peripheral T-Cell Lymphoma (PTCL) Rochester, Minn., Jacksonville, Fla., Scottsdale/Phoenix, Ariz.

  This phase II trial studies how well nivolumab works in treating patients with peripheral T-cell lymphoma that has come back after a period of improvement or that does not respond to treatment. Monoclonal antibodies, such as nivolumab, may block cancer growth in different ways by targeting certain cells.