Study on TTI-622 and Pembrolizumab for Treating Relapsed or Hard-to-Treat Diffuse Large B-Cell Lymphoma

Sponsor: Mayo Clinic

Sponsor score: 60
Inactive

ClinicalTrials ID:NCT05507541

Provider View

This clinical trial is testing a new combination of drugs, TTI-622 and pembrolizumab, to see if they can help treat diffuse large B-cell lymphoma that has returned or is not responding to treatment. The study aims to find the safest dose and evaluate how well the treatment works.

Patient Parameters

Program Overview

This study is exploring a new treatment for diffuse large B-cell lymphoma (DLBCL) that has come back or is not responding to current treatments. The trial is testing a combination of two drugs: TTI-622, which helps the immune system find and attack cancer cells, and pembrolizumab, which boosts the immune system's ability to fight cancer. The main goals are to determine the safest dose of TTI-622 and to see if this combination can effectively reduce cancer in patients.

Description

The study is divided into two parts. In the first part, researchers will determine the safest dose of TTI-622 when combined with pembrolizumab. In the second part, they will evaluate how well this combination works in shrinking tumors.

Participants will be assigned to one of two groups. Group A (closed to new participants) received pembrolizumab and TTI-621, while Group B will receive pembrolizumab and TTI-622. Both groups will receive treatment every 21 days for up to 12 cycles, with the possibility of continuing for up to 23 cycles if the cancer does not progress and side effects are manageable.

Throughout the study, participants will undergo regular scans and blood tests to monitor their response to the treatment. They may also have biopsies to provide more information about how the treatment is working.

After completing the treatment, participants will have follow-up visits every six months for up to two years to monitor their health and any long-term effects of the treatment.

Eligibility Criteria

Inclusion Criteria

  • Be 18 years or older.
  • Have a confirmed diagnosis of diffuse large B-cell lymphoma or related subtypes.
  • The cancer must have returned or not responded to previous treatments, including anti-CD20 therapy.
  • Have measurable disease as defined by specific scan criteria.
  • Be in good overall health with an ECOG performance status of 0 or 1.
  • Have completed previous treatments, such as anti-CD20 therapy, at least four weeks prior.
  • Have adequate blood cell counts and organ function as determined by specific tests.
  • Women of childbearing potential must agree to use effective contraception during and after the study.
  • Men must agree to use contraception and refrain from donating sperm during and after the study.
  • Be willing to provide tissue and blood samples for research purposes.
  • Provide informed consent to participate in the study.

Exclusion Criteria

  • Have primary central nervous system lymphoma or known CNS involvement.
  • Have another active or past cancer, except for certain non-invasive cancers or those with a complete response for over two years.
  • Have received certain prior therapies or investigational agents within a specified time before the study.
  • Have significant heart disease or ongoing infectious diseases.
  • Have a history of autoimmune diseases requiring treatment or immunosuppressive therapy.
  • Have had a stem cell or organ transplant.
  • Be pregnant or breastfeeding.
  • Have a known allergy to pembrolizumab.
  • Have received prior anti-CD47 therapy.
  • Be taking certain anticoagulants, with some exceptions.

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