Tafasitamab + Polatuzumab Vedotin + Glofitamab for Diffuse Large B-Cell Lymphoma

(TPG Trial)

RW
Overseen ByRoxanne Wood
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new combination of three drugs to treat diffuse large B-cell lymphoma (DLBCL) or high-grade B-cell lymphoma (HGBL). The goal is to evaluate the effectiveness of this combination as a first-line treatment. It is open to individuals diagnosed with DLBCL or HGBL who have received minimal prior treatment for their lymphoma. Those experiencing symptoms and requiring immediate treatment might be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot use systemic immunosuppressive medications within 2 weeks before starting the study treatment, unless they are allowed for managing lymphoma.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of tafasitamab, polatuzumab vedotin, and glofitamab is generally safe for patients with certain types of lymphoma. Specifically, studies found that using glofitamab with polatuzumab vedotin remained safe even for patients with extensive prior treatments. While some side effects occurred, they were usually not serious enough to outweigh the potential benefits.

Additionally, tafasitamab has received approval for use with other drugs for similar conditions, indicating it is generally well-tolerated. However, more than half of the patients in some studies experienced side effects that were moderate to severe.

These findings suggest that while the combination treatment is generally safe, participants should remain aware of possible side effects and discuss them with their healthcare provider.12345

Why are researchers excited about this trial's treatments?

Researchers are excited about the combination of Tafasitamab, Polatuzumab Vedotin, and Glofitamab for treating Diffuse Large B-Cell Lymphoma because each component offers a unique mechanism of action. Tafasitamab is an antibody that targets CD19 on B-cells, enhancing the immune response against cancer cells. Polatuzumab Vedotin delivers a potent chemotherapy agent directly to B-cells by targeting CD79b, minimizing damage to healthy cells. Glofitamab is a bispecific antibody that connects T-cells to cancer cells, boosting the body’s ability to attack tumors. This combination could offer a more targeted and potentially more effective alternative to existing treatments like R-CHOP, which primarily rely on broad cytotoxic chemotherapy.

What evidence suggests that this trial's treatments could be effective for diffuse large B-cell lymphoma?

Research has shown that combining the drugs glofitamab and polatuzumab vedotin holds promise for treating certain types of lymphoma. Studies have found that this combination can lead to high response rates and long-lasting remissions, even in patients who have tried multiple treatments before. For example, one study reported an overall response rate of 59%. Tafasitamab, another drug included in the TPG therapy under study in this trial, targets specific cancer cells, potentially improving treatment effectiveness. While the exact effectiveness of using all three drugs together is still under investigation in this trial, each drug has demonstrated strong results in treating similar conditions. These findings suggest that this combination could offer a powerful new option for patients with diffuse large B-cell lymphoma.25678

Who Is on the Research Team?

AO

Adam Olszewski

Principal Investigator

Brown University Health

Are You a Good Fit for This Trial?

This trial is for adults (18 or older) with certain types of aggressive B-cell lymphomas, including diffuse large B-cell lymphoma and high-grade B-cell lymphoma. Participants must be able to give informed consent and follow study procedures.

Inclusion Criteria

I am able and willing to understand and sign consent forms for the study.
I have EBV-positive diffuse large B-cell lymphoma.
I am 18 years old or older.
See 7 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive TPG therapy for the first four 21-day cycles, followed by response-adapted therapy based on PET-CT assessment

12 weeks
4 visits (in-person)

Response Assessment

Primary endpoint evaluation using PET-CT based Lugano criteria to determine subsequent therapy

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of progression-free survival and overall survival

Up to 5 years

What Are the Treatments Tested in This Trial?

Interventions

  • Glofitamab
  • Polatuzumab Vedotin
  • Tafasitamab

Trial Overview

The study is testing a new combination of three drugs—tafasitamab, polatuzumab vedotin, and glofitamab—as the first treatment for these lymphomas. All participants receive this drug combo in an open-label phase 2 trial.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: TPG therapyExperimental Treatment4 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Brown University

Lead Sponsor

Trials
480
Recruited
724,000+

Incyte Corporation

Industry Sponsor

Trials
408
Recruited
66,800+
Steven Stein profile image

Steven Stein

Incyte Corporation

Chief Medical Officer since 2015

MD from University of Witwatersrand

Hervé Hoppenot profile image

Hervé Hoppenot

Incyte Corporation

Chief Executive Officer since 2014

MBA from ESSEC Business School

Genentech, Inc.

Industry Sponsor

Trials
1,578
Recruited
569,000+
Ashley Magargee profile image

Ashley Magargee

Genentech, Inc.

Chief Executive Officer since 2024

MBA from Harvard University, BA from Princeton University

Levi Garraway profile image

Levi Garraway

Genentech, Inc.

Chief Medical Officer since 2021

MD, PhD

Natera, Inc.

Industry Sponsor

Trials
56
Recruited
50,700+

Citations

Efficacy and Safety of Glofitamab Plus Polatuzumab ...

Glofitamab and polatuzumab vedotin are novel treatments with promising antilymphoma activity when delivered in combination (Glofit-Pola). This ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41115257/

Efficacy and Safety of Glofitamab Plus Polatuzumab ...

Glofit-Pola demonstrated high efficacy and durable responses, with manageable safety, in heavily pretreated patients with R/R LBCL, ...

Tafasitamab + Polatuzumab Vedotin + Glofitamab for ...

This is a single-center, phase 2, open-label clinical trial of a novel combination of polatuzumab vedotin, glofitamab, and tafasitamab (TPG) ...

Combination Glofitamab and Polatuzumab Vedotin ...

It has an overall response rate of 59.0%, the study authors noted. Polatuzumab vedotin has also shown efficacy when administered in conjunction ...

Real-world outcomes of patients with aggressive B-cell ...

Key PointsBispecifics had an ORR and CR rate of 51.7% and 25.4%, respectively; median PFS and OS were 2.5 and 7.8 months, respectively.

761163Orig1s000 - accessdata.fda.gov

Based on the efficacy and safety information currently available, the clinical reviewer recommends approval of tafasitamab-cxix in combination ...

Tafasitamab for the treatment of patients with diffuse large B ...

This study reported outcomes for three pre-specified treatments not assessed in the RE-MIND study which included treatment with polatuzumab vedotin in ...

Safety and efficacy of glofitamab for relapsed/refractory large ...

Glofitamab has a 46% ORR (27% CR; 19% PR) and a manageable safety in heavily pretreated patients with r/r LBCL. Increased lactate dehydrogenase is the ...