Tafasitamab Clinical Trials

What Is Tafasitamab?

Tafasitamab is a medication being studied for various types of B-cell lymphomas. It is a cytolytic monoclonal antibody that specifically targets the CD19 protein found on the surface of B cells. By binding to CD19, tafasitamab helps to destroy these cells, which can be overactive or cancerous in certain conditions. This mechanism is being explored for its potential to treat conditions like relapsed/refractory Diffuse Large B-cell Lymphoma (DLBCL).

More than 80,000 cases of non-Hodgkin lymphoma (NHL) are diagnosed each year in the United States, with B-cell lymphomas being much more common than T-cell lymphomas. Tafasitamab is being evaluated in clinical trials, often in combination with other therapies like lenalidomide, for its safety, tolerability, and potential clinical benefits in participants with relapsed/refractory DLBCL not eligible for autologous stem cell transplant. A total of 50 trials involving 4,528 participants have been conducted or are ongoing since the first trial began in 2015.

Uses and Conditions Under Study

Tafasitamab is primarily being investigated for its use in treating various B-cell lymphomas, which are cancers that originate from B lymphocytes. These conditions are characterized by the uncontrolled growth of abnormal B cells, which tafasitamab aims to target and eliminate.

• Diffuse Large B-cell Lymphoma (DLBCL): This is an aggressive type of non-Hodgkin lymphoma and the most common B-cell lymphoma. Tafasitamab is being studied in a combined total of 18 trials for this condition (including "Diffuse Large B-cell Lymphoma," "Diffuse Large B Cell Lymphoma," and "DLBCL"), often focusing on relapsed/refractory cases. The drug's ability to target CD19 on B cells may help control the progression of DLBCL.
• Other B-cell Lymphomas: Tafasitamab is also being explored for other B-cell cancers. This includes Chronic Lymphocytic Leukemia (CLL) (6 trials), Small Lymphocytic Lymphoma (SLL) (4 trials), Follicular Lymphoma (FL) (4 trials), Marginal Zone Lymphoma (MZL) (4 trials), Mantle Cell Lymphoma (MCL) (3 trials), and general B-Cell Lymphoma (3 trials). These studies aim to assess tafasitamab's effectiveness across a broader spectrum of B-cell malignancies.

Dosing

Tafasitamab is administered through different routes and regimens depending on the specific clinical trial and combination therapy being investigated. The drug is a monoclonal antibody, typically given intravenously or subcutaneously.

• Intravenous (IV) Administration: One common regimen involves administering tafasitamab 12 mg/kg IV on Day 1, Day 8, Day 15, and Day 22 within a treatment cycle. This method ensures the drug is delivered directly into the bloodstream.
• Subcutaneous (SC) Administration: Another studied approach involves subcutaneous injection. This is typically given once weekly during cycles 1-3, and then every 4 weeks for cycles 4-12. This route may offer convenience for long-term maintenance therapy.
• Combination Therapies: Tafasitamab is frequently studied as part of combination regimens. For example, it has been investigated with lenalidomide, rituximab, acalabrutinib, venetoclax, and various chemotherapy regimens like gemcitabine and oxaliplatin (GemOx). Some trials also explore tafasitamab alongside novel agents such as orelabrutinib (150 mg orally once daily) or allogeneic NK cells. These combinations aim to enhance treatment efficacy for conditions like Diffuse Large B-cell Lymphoma.

Dosing strategies, including dose escalation and expansion phases, are carefully evaluated in clinical trials to determine the optimal balance of safety and effectiveness for adult participants. No specific pediatric doses were detailed in the provided trial information.

Side Effects

In a clinical trial involving 979 patients, the most common side effect reported with Tafasitamab was neutropenia. Neutropenia occurred in 49.2% of patients taking Tafasitamab, compared to 47.4% of patients on placebo. Other common side effects included:

• Diarrhea: 35.4% of patients on Tafasitamab experienced diarrhea, compared to 31.1% on placebo.
• Constipation: 26.7% of patients on Tafasitamab experienced constipation, compared to 24.9% on placebo.
• Rash: 21.9% of patients on Tafasitamab experienced a rash, compared to 21.5% on placebo.
• Fatigue: 19.1% of patients on Tafasitamab experienced fatigue, compared to 16.3% on placebo.
• Cough: 18.3% of patients on Tafasitamab experienced a cough, compared to 16.9% on placebo.
• Pyrexia (fever): 17.3% of patients on Tafasitamab experienced pyrexia, compared to 15.1% on placebo.
• Nausea: 16.9% of patients on Tafasitamab experienced nausea, compared to 14.5% on placebo.

Less common side effects included muscle spasms (16.6% on Tafasitamab vs 17.5% on placebo), thrombocytopenia (low platelet count) (15.8% on Tafasitamab vs 18.2% on placebo), infusion-related reactions (15.6% on Tafasitamab vs 15.1% on placebo), and anemia (low red blood cell count) (15.5% on Tafasitamab vs 14.2% on placebo).

Clinical Trial Results

Relapsed/Refractory Diffuse Large B-cell Lymphoma (R/R DLBCL)

In an open-label study (NCT02399085) of 81 patients with R/R DLBCL treated with Tafasitamab plus lenalidomide:

• The objective response rate (ORR), meaning the percentage of patients whose cancer responded to treatment, was 56.8%.
• The median duration of response (DoR), the length of time patients continued to respond to treatment, was 43.9 months.
• The median overall survival (OS) was 33.5 months.
• The median progression-free survival (PFS), the time patients lived without their disease worsening, was 11.6 months.

Another study (NCT02763319) compared Tafasitamab plus bendam

Currently Recruiting Trials

Tafasitamab is currently being investigated in a range of clinical trials for various blood cancers and autoimmune conditions. These studies aim to further understand its safety and effectiveness, often in combination with other therapies. If you or a loved one are considering participating in a clinical trial, here are some of the studies actively seeking participants:

• A Phase 2 study, sponsored by Masonic Cancer Center, University of Minnesota, is enrolling up to 65 participants with treatment-naïve Follicular Lymphoma or Marginal Zone Lymphoma. This trial (NCT06792825) evaluates tafasitamab with lenalidomide and rituximab.
• The Grupo Español de Linfomas y Transplante Autólogo de Médula Ósea is sponsoring a Phase 2, response-adaptive study (NCT07126236) that plans to enroll 80 patients with relapsed/refractory Large B Cell Lymphoma. It explores epcoritamab monotherapy or in combination with tafasitamab.
• H. Lee Moffitt Cancer Center and Research Institute is sponsoring a Phase 2 study (NCT06760156) for 28 participants with Large B-cell Lymphoma after axicabtagene ciloleucel (axi-cel) treatment, assessing tafasitamab and lenalidomide as first salvage therapy.
• A Phase 2 pilot trial from the University of Cologne (NCT05583071) is enrolling 20 patients with Primary Central Nervous System Lymphoma (PCNSL) who are ineligible for HCT-ASCT, investigating tafasitamab, lenalidomide, rituximab, and methotrexate.
• M.D. Anderson Cancer Center is conducting a Phase 1/2 study (NCT06434363) for 47 participants with Autoimmune Disorders, including Systemic Sclerosis and Lupus. It aims to confirm tafasitamab's safety and find the recommended dose of AD-PluReceptor-NK cells in combination with tafasitamab.
• Beijing InnoCare Pharma Tech Co., Ltd. is sponsoring a Phase 3 study (NCT06521255) with an enrollment target of 244. This randomized, multicenter trial compares tafasitamab and lenalidomide with gemcitabine and oxaliplatin against rituximab with gemcitabine and oxaliplatin for relapsed/refractory Diffuse Large B-Cell Lymphoma (DLBCL).
• A Phase 1/2 study sponsored by Alvaro Alencar, MD (NCT06029309), is enrolling 27 patients with Mantle Cell Lymphoma to find the ideal dose and assess the effectiveness of zanubrutinib and tafasitamab.
• Academic and Community Cancer Research United is conducting a Phase 2 trial (NCT05910801) for 100 participants with relapsed or refractory Mantle Cell Lymphoma, evaluating tafasitamab, lenalidomide, and venetoclax.
• OHSU Knight Cancer Institute is sponsoring a Phase 1 study (NCT05943496) for 27 patients with previously untreated Chronic Lymphocytic Leukemia and Small Lymphocytic Lymphoma, testing the safety and effectiveness of tafasitamab, acalabrutinib, and obinutuzumab.
• The SWOG Cancer Research Network is leading a Phase 2 study (NCT05890352) with 227 participants who have large B-cell lymphoma that has returned or not responded to treatment. This trial explores combinations of tafasitamab and lenalidomide with tazemetostat or zanubrutinib.
• David Bond, MD, is sponsoring a Phase 2 study (NCT05821088) for 37 transplant-eligible patients with relapsed/refractory Large B-Cell Lymphoma, evaluating tafasitamab and lenalidomide followed by tafasitamab and the ICE regimen.
• M.D. Anderson Cancer Center is conducting a Phase 2 trial (NCT05615636) for 36 patients with relapsed B-cell NHL, including FL and DLBCL, to assess mosunetuzumab, polatuzumab, tafasitamab, and lenalidomide.
• Timothy Voorhees is sponsoring a Phase 2 study (NCT05786040) for 28 patients with post-transplant lymphoproliferative disorder, evaluating tafasitamab and rituximab as front-line treatment.
• University Hospital Tuebingen is conducting a Phase 1/2 study (NCT05366218) for 20 pediatric patients with relapsed or refractory Acute B Lineage Leukemia, focusing on tafasitamab safety and immunological effects.
• The University of Washington is sponsoring a Phase 1/2 trial (NCT05455697) for 35 participants with Diffuse Large B-Cell Lymphoma, Grade 3b Follicular Lymphoma, or High Grade B-Cell Lymphoma. It tests tafasitamab, retifanlimab, and rituximab (TRR) in combination with standard therapy.
• Incyte Corporation is sponsoring a Phase 2 extension study (NCT06465433) for 25 patients with hematologic malignancies who are already benefiting from tafasitamab in a previous study, providing continued treatment.
• James Rubenstein is sponsoring a Phase 1/2 study (NCT05351593) for 35 patients with relapsed Central Nervous System Lymphoma, investigating tafasitamab plus lenalidomide.
• Beijing InnoCare Pharma Tech Co., Ltd. is sponsoring a Phase 2 study (NCT05552937) for 50 patients with relapsed or refractory DLBCL, evaluating tafasitamab combined with lenalidomide.

Where to Participate

Tafasitamab trials are accessible across a wide geographic area, with studies active at 118 sites in 92 cities across 22 states. This broad reach aims to make participation convenient for a diverse patient population.

Top locations with multiple recruiting sites include:

• Houston, Texas (6 sites)
• Flint, Michigan (4 sites)
• St Louis, Missouri (3 sites)
• Milwaukee, Wisconsin (3 sites)
• Portland, Oregon (3 sites)
• Munster, Indiana (2 sites)
• Hobart, Indiana (2 sites)
• Ypsilanti, Michigan (2 sites)
• Salt Lake City, Utah (2 sites)
• Columbus, Ohio (2 sites)

Most trials generally enroll participants aged 3 to 99 years, of all genders. Healthy volunteers are not typically included, but children are eligible for some studies, reflecting the diverse conditions under investigation.

Development Timeline

Tafasitamab's clinical development began on March 26, 2015, marking the start of its journey through clinical trials. Since then, a total of 50 clinical trials have been initiated, enrolling approximately 4,528 participants to evaluate its potential.

Early development was driven by companies like MorphoSys AG, with Incyte Corporation becoming a significant sponsor, leading 8 studies. Other key contributors include M.D. Anderson Cancer Center and Beijing InnoCare Pharma Tech Co., Ltd. The majority of studies are in Phase 2 (24 trials) and Phase 1/2 (13 trials), indicating ongoing investigation into its efficacy and optimal use. There are also 4 Phase 3 studies, which are typically larger trials designed to confirm effectiveness and monitor side effects.

Tafasitamab's journey initially explored conditions like IBS-C and hyperphosphatemia. However, its development quickly focused on hematologic malignancies. The pipeline significantly expanded to target a broad spectrum of B-cell lymphomas, including Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma, Marginal Zone Lymphoma, and Mantle Cell Lymphoma. More recently, studies have also begun to investigate its potential in Chronic Lymphocytic Leukemia, Acute B Lineage Leukemia, Post-Transplant Lymphoproliferative Disorder, and even certain Autoimmune Disorders like Systemic Lupus Erythematosus. This demonstrates a strategic evolution in its therapeutic focus, with the latest trial projected to conclude in May 2026.