Arm B (pembrolizumab, TTI-622) for Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Mayo Clinic in Rochester, Rochester, MN
Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type+35 More
Biospecimen Collection - Procedure
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This phase II trial tests the safety, side effects, and best dose of TTI-621 or TTI-622 in combination with pembrolizumab in treating patients with diffuse large B-Cell lymphoma that has come back (relapsed). TTI-621 and TTI-622 are called fusion proteins. A fusion protein includes two specialized proteins that are joined together. In TTI-621 and TTI-622, one of the proteins binds with other proteins found on the surface of certain cells that are part of the immune system. The other protein targets and blocks a protein called CD47. CD47 is present on cancer cells and is used by those cells to hide from the body's immune system. By blocking CD47, TTI-621 and TTI-622 may help the immune system find and destroy cancer cells. Pembrolizumab is a monoclonal antibody directed against human cell surface receptor PD-1 (programmed death-1 or programmed cell death-1) that works by helping the body's immune system attack the cancer and may interfere with the ability of cancer cells to grow and spread. Giving TTI-621 or TTI-622 in combination with pembrolizumab may kill more cancer cells in patients with relapsed or refractory diffuse large B-cell lymphoma.

Eligible Conditions

  • Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
  • Refractory High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent ALK Positive Large B-Cell Lymphoma
  • Refractory EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Recurrent High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent Intravascular Large B-Cell Lymphoma
  • Recurrent T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Refractory Grade 3b Follicular Lymphoma
  • Refractory Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Refractory Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
  • Refractory T-Cell/Histiocyte-Rich Large B-Cell Lymphoma
  • Refractory Intravascular Large B-Cell Lymphoma
  • Recurrent EBV-Positive Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory ALK Positive Large B-Cell Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Recurrent High Grade B-Cell Lymphoma, Not Otherwise Specified
  • Refractory B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Recurrent Primary Mediastinal (Thymic) Large B-Cell Cell Lymphoma
  • Recurrent Grade 3b Follicular Lymphoma
  • Recurrent B-Cell Lymphoma, Unclassifiable, With Features Intermediate Between Diffuse Large B-Cell Lymphoma and Classic Hodgkin Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory High Grade B-Cell Lymphoma
  • Recurrent Diffuse Large B-Cell Lymphoma Associated With Chronic Inflammation
  • Recurrent High Grade B-Cell Lymphoma
  • Recurrent B-Cell Non-Hodgkin Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC, BCL2, and BCL6 Rearrangements
  • Recurrent Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Diffuse Large B-Cell Lymphoma, Not Otherwise Specified
  • Refractory Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type

Study Objectives

2 Primary · 4 Secondary · Reporting Duration: Up to 2 years

Year 2
Overall survival (OS) (Phase 2)
Year 2
Progression-free survival (PFS) (Phase 2)
Up to 2 years
Duration of response (DOR) (Phase 2)
Incidence of adverse events (AEs) (Phase 2)
Overall response (Phase 2)
Up to 6 weeks
Recommended phase 2 dose of TTI-621 and TTI-622 when given in combination with pembrolizumab (Safety run-in)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Other trials for Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type

Trial Design

2 Treatment Groups

Arm B (pembrolizumab, TTI-622)
1 of 2
Arm A (pembrolizumab, TTI-621)
1 of 2
Experimental Treatment

62 Total Participants · 2 Treatment Groups

Primary Treatment: Arm B (pembrolizumab, TTI-622) · No Placebo Group · Phase 2

Arm B (pembrolizumab, TTI-622)Experimental Group · 5 Interventions: Biospecimen Collection, Computed Tomography, Positron Emission Tomography, SIRPa-IgG4-Fc Fusion Protein TTI-622, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Biological
Arm A (pembrolizumab, TTI-621)Experimental Group · 5 Interventions: Biospecimen Collection, Computed Tomography, Positron Emission Tomography, Ontorpacept, Pembrolizumab · Intervention Types: Procedure, Procedure, Procedure, Drug, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 1
~430
Computed Tomography
2017
Completed Phase 2
~3460
Positron Emission Tomography
2019
Completed Phase 2
~3050
Pembrolizumab
2017
Completed Phase 3
~2950

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to 2 years
Closest Location: Mayo Clinic in Rochester · Rochester, MN
Photo of Rochester  1Photo of Rochester  2Photo of Rochester  3
2021First Recorded Clinical Trial
2 TrialsResearching Recurrent Primary Cutaneous Diffuse Large B-Cell Lymphoma, Leg Type
502 CompletedClinical Trials

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have high-grade B-cell lymphoma, NOS.
You have a primary mediastinal (thymic) large B-cell lymphoma.
You have follicular lymphoma 3B.
Diffuse large B-cell lymphoma NOS.
You have germinal center B-cells.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.